Publications by authors named "Neil Aaronson"

283 Publications

A prospective prostate cancer screening programme for men with pathogenic variants in mismatch repair genes (IMPACT): initial results from an international prospective study.

Lancet Oncol 2021 11 19;22(11):1618-1631. Epub 2021 Oct 19.

University Hospital Southampton, Southampton, UK; Wessex Clinical Genetics Service, Princess Anne Hospital, Southampton, UK.

Background: Lynch syndrome is a rare familial cancer syndrome caused by pathogenic variants in the mismatch repair genes MLH1, MSH2, MSH6, or PMS2, that cause predisposition to various cancers, predominantly colorectal and endometrial cancer. Data are emerging that pathogenic variants in mismatch repair genes increase the risk of early-onset aggressive prostate cancer. The IMPACT study is prospectively assessing prostate-specific antigen (PSA) screening in men with germline mismatch repair pathogenic variants. Here, we report the usefulness of PSA screening, prostate cancer incidence, and tumour characteristics after the first screening round in men with and without these germline pathogenic variants.

Methods: The IMPACT study is an international, prospective study. Men aged 40-69 years without a previous prostate cancer diagnosis and with a known germline pathogenic variant in the MLH1, MSH2, or MSH6 gene, and age-matched male controls who tested negative for a familial pathogenic variant in these genes were recruited from 34 genetic and urology clinics in eight countries, and underwent a baseline PSA screening. Men who had a PSA level higher than 3·0 ng/mL were offered a transrectal, ultrasound-guided, prostate biopsy and a histopathological analysis was done. All participants are undergoing a minimum of 5 years' annual screening. The primary endpoint was to determine the incidence, stage, and pathology of screening-detected prostate cancer in carriers of pathogenic variants compared with non-carrier controls. We used Fisher's exact test to compare the number of cases, cancer incidence, and positive predictive values of the PSA cutoff and biopsy between carriers and non-carriers and the differences between disease types (ie, cancer vs no cancer, clinically significant cancer vs no cancer). We assessed screening outcomes and tumour characteristics by pathogenic variant status. Here we present results from the first round of PSA screening in the IMPACT study. This study is registered with ClinicalTrials.gov, NCT00261456, and is now closed to accrual.

Findings: Between Sept 28, 2012, and March 1, 2020, 828 men were recruited (644 carriers of mismatch repair pathogenic variants [204 carriers of MLH1, 305 carriers of MSH2, and 135 carriers of MSH6] and 184 non-carrier controls [65 non-carriers of MLH1, 76 non-carriers of MSH2, and 43 non-carriers of MSH6]), and in order to boost the sample size for the non-carrier control groups, we randomly selected 134 non-carriers from the BRCA1 and BRCA2 cohort of the IMPACT study, who were included in all three non-carrier cohorts. Men were predominantly of European ancestry (899 [93%] of 953 with available data), with a mean age of 52·8 years (SD 8·3). Within the first screening round, 56 (6%) men had a PSA concentration of more than 3·0 ng/mL and 35 (4%) biopsies were done. The overall incidence of prostate cancer was 1·9% (18 of 962; 95% CI 1·1-2·9). The incidence among MSH2 carriers was 4·3% (13 of 305; 95% CI 2·3-7·2), MSH2 non-carrier controls was 0·5% (one of 210; 0·0-2·6), MSH6 carriers was 3·0% (four of 135; 0·8-7·4), and none were detected among the MLH1 carriers, MLH1 non-carrier controls, and MSH6 non-carrier controls. Prostate cancer incidence, using a PSA threshold of higher than 3·0 ng/mL, was higher in MSH2 carriers than in MSH2 non-carrier controls (4·3% vs 0·5%; p=0·011) and MSH6 carriers than MSH6 non-carrier controls (3·0% vs 0%; p=0·034). The overall positive predictive value of biopsy using a PSA threshold of 3·0 ng/mL was 51·4% (95% CI 34·0-68·6), and the overall positive predictive value of a PSA threshold of 3·0 ng/mL was 32·1% (20·3-46·0).

Interpretation: After the first screening round, carriers of MSH2 and MSH6 pathogenic variants had a higher incidence of prostate cancer compared with age-matched non-carrier controls. These findings support the use of targeted PSA screening in these men to identify those with clinically significant prostate cancer. Further annual screening rounds will need to confirm these findings.

Funding: Cancer Research UK, The Ronald and Rita McAulay Foundation, the National Institute for Health Research support to Biomedical Research Centres (The Institute of Cancer Research and Royal Marsden NHS Foundation Trust; Oxford; Manchester and the Cambridge Clinical Research Centre), Mr and Mrs Jack Baker, the Cancer Council of Tasmania, Cancer Australia, Prostate Cancer Foundation of Australia, Cancer Council of Victoria, Cancer Council of South Australia, the Victorian Cancer Agency, Cancer Australia, Prostate Cancer Foundation of Australia, Asociación Española Contra el Cáncer (AECC), the Instituto de Salud Carlos III, Fondo Europeo de Desarrollo Regional (FEDER), the Institut Català de la Salut, Autonomous Government of Catalonia, Fundação para a Ciência e a Tecnologia, National Institutes of Health National Cancer Institute, Swedish Cancer Society, General Hospital in Malmö Foundation for Combating Cancer.
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http://dx.doi.org/10.1016/S1470-2045(21)00522-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8576477PMC
November 2021

Characteristics of Participants and Nonparticipants in a Blended Internet-Based Physical Activity Trial for Breast and Prostate Cancer Survivors: Cross-sectional Study.

JMIR Cancer 2021 Oct 5;7(4):e25464. Epub 2021 Oct 5.

Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, Netherlands.

Background: As the number of cancer survivors is increasing, it is important to be able to offer exercise and physical activity (PA)-promoting interventions that are both effective and reasonably accessible. Internet-based interventions are typically less expensive and more accessible alternatives to on-site supervised interventions. Currently, little is known about the characteristics of nonparticipants in PA promotion trials in the cancer survivorship setting, both in general and specifically in trials using internet-supported interventions.

Objective: This study aims to gain insight into the characteristics associated with nonparticipation in a blended internet-based supported intervention trial to promote PA.

Methods: Breast and prostate cancer survivors, 3-36 months after primary curative treatment, were invited to participate in the PABLO trial; this trial compared an internet-based intervention to enhance PA levels, with or without additional support from a physical therapist, to usual care. Participants and nonparticipants were asked to complete a comprehensive questionnaire assessing sociodemographics, fatigue, and health-related quality of life. Baseline data for participants and nonparticipants were compared using the independent Student t test and chi-square test.

Results: The inclusion rate in the trial was 11.03% (137/1242). Of the nonparticipants, 13.95% (154/1104) completed the questionnaire. Participants were more highly educated (P=.04), had a paid job less often (P=.03), and were on sick leave more often (P=.03). They reported less PA per week, both moderate (P=.03) and vigorous (P<.01), before diagnosis and during leisure time (P<.01, effect size [ES]=0.44). They reported a significantly lower stage of change (P≤.01), lower self-efficacy (P<.01, ES=0.61), perceived barriers to PA (P<.01, ES=0.54), and more general fatigue (P<.01, ES=0.60). Participants reported lower health-related quality of life for most domains (ES ranging from 0.34 for mental health to 0.48 for social functioning). No significant differences were found for other sociodemographics, mood state, or attitudes toward or perceived social support for PA.

Conclusions: The participants who self-selected for trial participation reported lower PA levels before diagnosis and a stronger need for support compared with nonparticipants. The trial thus included those patients who might benefit the most from internet-based supportive PA interventions.

Trial Registration: Netherlands trial register NTR6911; https://www.trialregister.nl/trial/6733.
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http://dx.doi.org/10.2196/25464DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8527379PMC
October 2021

Validation and reliability of the Dutch version of the EORTC QLQ-NMIBC24 Questionnaire Module for patients with non-muscle-invasive bladder cancer.

J Patient Rep Outcomes 2021 Sep 20;5(1):96. Epub 2021 Sep 20.

Department for Health Evidence, Radboud Institute for Health Sciences, Radboud University Medical Center, PO Box 9101, 6500 HB, Nijmegen, The Netherlands.

Background: The European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire for non-muscle invasive bladder cancer (QLQ-NMIBC24) has been available and applied for some years now, but has yet to undergo a full comprehensive psychometric evaluation. The aim of this study was to investigate the psychometric properties of the Dutch version of the EORTC QLQ-NMIBC24 questionnaire in patients with low, intermediate and high risk NMIBC.

Methods: We included patients newly diagnosed with NMIBC participating in the multicenter, population-based prospective cohort studies UroLife or BlaZIB. Psychometric evaluation included examination of the structural validity, reliability (i.e. internal consistency and test-retest reliability), construct validity (i.e. divergent validity and known-groups validity), responsiveness and interpretability.

Results: A total of 1463 patients who completed the baseline questionnaire of UroLife (n = 541, response rate 50%) or BlaZIB (n = 922, response rate 58%) were included. The percentage of missing responses were low for all non-sex related scales (< 1%) and ranged between 6.9% to 50.0% for sex-related scales. More than 15% of the patients obtained the lowest possible scores on nearly each scale (floor effect). The structural validity was adequate; the confirmatory factor analysis showed satisfactory results and all items of multiple items scales had higher within- than between-scale correlations. Reliability of the questionnaire was adequate for most multiple item scales (Cronbach's α ≥ 0.70 and intraclass correlation coefficient ≥ 0.70), with exception of the scales 'malaise' and 'bloating and flatulence'. The questionnaire also showed good construct validity; it showed low correlations with the items of the EORTC core questionnaire and was able to measure differences between risk-based subgroups. The responsiveness of the questionnaire was good, but the interpretability, i.e. minimal important change, could not be determined.

Conclusions: This study shows that the measurement properties of the EORTC QLQL-NMIBC24 are good; it has a good structural validity, reliability (i.e. internal consistency and test-retest reliability), construct validity (i.e. divergent validity and known-group validity), and responsiveness. Interpretability could not be assessed. This questionnaire can be used to measure and monitor health-related quality of life of patients with NMIBC.
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http://dx.doi.org/10.1186/s41687-021-00372-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8452806PMC
September 2021

SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung): study protocol for a stepped-wedge randomised controlled trial.

BMJ Open 2021 09 13;11(9):e052494. Epub 2021 Sep 13.

Department for Health Evidence, Radboud University Medical Center, Nijmegen, Gelderland, The Netherlands.

Introduction: Lung cancer and its treatment cause a wide range of symptoms impacting the patients' health-related quality of life (HRQoL). The use of patient-reported outcomes (PRO) to monitor symptoms during and after cancer treatment has been shown not only to improve symptom management but also to improve HRQoL and overall survival (OS). Collectively, these results favour implementation of PRO-symptom monitoring in daily clinical care. However, these promising outcomes have been obtained under trial conditions in which patients were selected based on stringent inclusion criteria, and in countries with a dissimilar healthcare system than in the Netherlands.The primary aim of the SYMptom monitoring with Patient-Reported Outcomes using a web application among patients with Lung cancer in the Netherlands (SYMPRO-Lung) study is to evaluate the effect of PRO-symptom monitoring during and after lung cancer treatment on HRQoL in daily clinical practice. Secondary objectives include assessing the effect of PRO-symptom monitoring on progression-free survival, OS, the incidence and grade of PRO symptoms, medication adherence, implementation fidelity and cost-effectiveness.

Methods And Analysis: The SYMPRO-Lung study is a prospective, multicentre trial with a stepped wedge cluster randomised design. Study participants (n=292 intervention, n=292 controls) include patients with lung cancer (stages I-IV) starting treatment with surgery, systemic treatment, targeted treatment and/or radiotherapy.Every participating centre will consecutively switch from the control period to the intervention period, in which patients report their symptoms weekly via an online tool. In the intervention group, we evaluate two alert approaches: the active and reactive approach. If the symptoms exceed a predefined threshold, an alert is sent to the healthcare provider (active approach) or to the patient (reactive approach). Both the control and intervention group complete HRQoL questionnaires at 4 time points: at baseline, 15 weeks, 6 months and 1-year post treatment). Differences in HRQoL between the groups will be compared using linear mixed modelling analyses, accounting for within-centre clustering, potential time effects and confounding.

Ethics And Dissemination: The study protocol was approved by the Institutional Review Board and the Medical Ethics Committee of the Amsterdam UMC (under number NL 68440.029.18) and the institutional review boards of the participating study sites. The dissemination of the results will be conducted through publication in peer-reviewed journals and through scientific conferences.

Trial Registration Number: Trial register identifier: Netherlands Trial register Trial NL7897. Date of registration: 24 July 2019. https://www.trialregister.nl/trial/7897.
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http://dx.doi.org/10.1136/bmjopen-2021-052494DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8438957PMC
September 2021

Impact of Blinding on Patient-Reported Outcome Differences between Treatment Arms in Cancer Randomized Controlled Trials.

J Natl Cancer Inst 2021 Sep 11. Epub 2021 Sep 11.

University Hospital of Psychiatry II, Medical University of Innsbruck, Innsbruck, Austria.

Some concerns have been raised about potential bias in patient-reported outcome (PRO) results from open-label cancer randomized controlled trials (RCTs). We investigated if open-label trials favor the experimental treatment over the standard treatment more frequently than blinded trials. We also examined if the effect of treatment concealment differs for distal vs more proximal PROs. We assessed 538 RCTs with a PRO endpoint conducted in the most prevalent cancers, of which 366 (68.0%) were open-label, 148 (27.5%) were blinded, and 24 (4.5%) were categorized as unclear. In our multivariable logistic regression model, we did not observe a statistically significant association of the independent variable treatment concealment (open-label vs blinded) on the dependent variable measuring the proportion of trials favoring the experimental treatment (adjusted odds ratio = 1.19, 95% confidence interval = 0.79 to 1.79, 2-sided P = .40. This was also the case when comparing distal and proximal PROs. Our findings provide novel evidence-based data that support the validity of PRO results from open label cancer RCTs.
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http://dx.doi.org/10.1093/jnci/djab177DOI Listing
September 2021

Efficacy of Physical Exercise to Offset Anthracycline-Induced Cardiotoxicity: A Systematic Review and Meta-Analysis of Clinical and Preclinical Studies.

J Am Heart Assoc 2021 09 2;10(17):e021580. Epub 2021 Sep 2.

Julius Center for Health Sciences and Primary Care University Medical Center UtrechtUtrecht University Utrecht The Netherlands.

Background Physical exercise is an intervention that might protect against doxorubicin-induced cardiotoxicity. In this meta-analysis and systematic review, we aimed to estimate the effect of exercise on doxorubicin-induced cardiotoxicity and to evaluate mechanisms underlying exercise-mediated cardioprotection using (pre)clinical evidence. Methods and Results We conducted a systematic search in PubMed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) databases. Cochrane's and Systematic Review Centre for Laboratory Animal Experimentation (SYRCLE) risk-of-bias tools were used to assess the validity of human and animal studies, respectively. Cardiotoxicity outcomes reported by ≥3 studies were pooled and structured around the type of exercise intervention. Forty articles were included, of which 3 were clinical studies. Overall, in humans (sample sizes ranging from 24 to 61), results were indicative of exercise-mediated cardioprotection, yet they were not sufficient to establish whether physical exercise protects against doxorubicin-induced cardiotoxicity. In animal studies (n=37), a pooled analysis demonstrated that forced exercise interventions significantly mitigated in vivo and ex vivo doxorubicin-induced cardiotoxicity compared with nonexercised controls. Similar yet slightly smaller effects were found for voluntary exercise interventions. We identified oxidative stress and related pathways, and less doxorubicin accumulation as mechanisms underlying exercise-induced cardioprotection, of which the latter could act as an overarching mechanism. Conclusions Animal studies indicate that various exercise interventions can protect against doxorubicin-induced cardiotoxicity in rodents. Less doxorubicin accumulation in cardiac tissue could be a key underlying mechanism. Given the preclinical evidence and limited availability of clinical data, larger and methodologically rigorous clinical studies are needed to clarify the role of physical exercise in preventing cardiotoxicity in patients with cancer. Registration URL: https://www.crd.york.ac.uk/prospero; Unique identifier: CRD42019118218.
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http://dx.doi.org/10.1161/JAHA.121.021580DOI Listing
September 2021

Oncology team perspectives on distress screening: a multisite study of a well-established use of patient-reported outcomes for clinical assessment.

Support Care Cancer 2021 Sep 1. Epub 2021 Sep 1.

Division of Psychosocial Research and Epidemiology, Netherlands Cancer Institute, Amsterdam, The Netherlands.

Purpose: Cancer care team attitudes towards distress screening are key to its success and sustainability. Previous qualitative research has interviewed staff mostly around the startup phase. We evaluate oncology teams' perspectives on psychosocial distress screening, including perceived strengths and challenges, in settings where it has been operational for years.

Methods: We conducted, transcribed, and analyzed semi-structured interviews with 71 cancer care team members (e.g., MDs, RNs, MSWs) at 18 Commission on Cancer-accredited cancer programs including those serving underrepresented populations.

Results: Strengths of distress screening identified by participants included identifying patient needs and testing provider assumptions. Staff indicated it improved patient-provider communication and other aspects of care. Challenges to distress screening included patient barriers (e.g., respondent burden) and lack of electronic system interoperability. Participants expressed the strengths of distress screening (n = 291) more than challenges (n = 86). Suggested improvements included use of technology to collect data, report results, and make referrals; complete screenings prior to appointments; longitudinal assessment; additional staff training; and improve resources to address patient needs.

Conclusion: Cancer care team members' perspectives on well-established distress screening programs largely replicate findings of previous studies focusing on the startup phase, but there are important differences: team members expressed more strengths than challenges, suggesting a positive attitude. While our sample described many challenges described previously, they did not indicate challenges with scoring and interpreting the distress screening questionnaire. The differences in attitudes expressed in response to mature versus startup implementations provide important insights to inform efforts to sustain and optimize distress screening.
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http://dx.doi.org/10.1007/s00520-021-06458-5DOI Listing
September 2021

Past and Current Practice of Patient-Reported Outcome Measurement in Randomized Cancer Clinical Trials: A Systematic Review.

Value Health 2021 04 10;24(4):585-591. Epub 2021 Feb 10.

Innsbruck Institute of Patient-centered Outcome Research (IIPCOR), Innsbruck, Austria.

Objectives: In our systematic review, we assessed past and current practice of patient-reported outcome (PRO) measurement in cancer randomized, controlled trials (RCTs).

Methods: We included RCTs with PRO endpoints evaluating conventional medical treatments, conducted in patients with the most prevalent solid tumor types (breast, lung, colorectal, prostate, bladder, and gynecological cancers) and either published in 2004 to 2018 or registered on clinicaltrials.gov and initiated in 2014 to 2019. Frequency of use of individual PRO measures was assessed overall, over time, and by cancer site.

Results: Screening of 42 095 database records and 3425 registered trials identified 480 published and 537 registered trials meeting inclusion criteria. Among published trials, the European Organisation for Research and Treatment of Cancer (EORTC) measures were used most often (54.8% of trials), followed by the Functional Assessment of Chronic Illness Therapy (FACIT) measures (35.8%), the EQ-5D (10.2%), the SF-36 (7.3%), and the MD Anderson Symptom Inventory (MDASI; 2.5%). Among registered trials, the EORTC measures were used in 66.1% of the trials, followed by the FACIT measures (25.9%), the EQ-5D (23.1%), the SF-36 (4.8%), the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE; 2.2%), the Patient-Reported Outcomes Measurement Information System (PROMIS) measures (1.7%), and the MDASI measures (1.1%).

Conclusion: The PRO measures most frequently used in RCTs identified in our review differ substantially in terms of content and domains, reflecting the ongoing debate among the scientific community, healthcare providers, and regulators on the type of PRO to be measured. Current findings may contribute to better informing the development of an internationally agreed core outcome set for future cancer trials.
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http://dx.doi.org/10.1016/j.jval.2020.11.004DOI Listing
April 2021

Does exercise intensity matter for fatigue during (neo-)adjuvant cancer treatment? The Phys-Can randomized clinical trial.

Scand J Med Sci Sports 2021 May 2;31(5):1144-1159. Epub 2021 Mar 2.

Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden.

Exercise during cancer treatment improves cancer-related fatigue (CRF), but the importance of exercise intensity for CRF is unclear. We compared the effects of high- vs low-to-moderate-intensity exercise with or without additional behavior change support (BCS) on CRF in patients undergoing (neo-)adjuvant cancer treatment. This was a multicenter, 2x2 factorial design randomized controlled trial (Clinical Trials NCT02473003) in Sweden. Participants recently diagnosed with breast (n = 457), prostate (n = 97) or colorectal (n = 23) cancer undergoing (neo-)adjuvant treatment were randomized to high intensity (n = 144), low-to-moderate intensity (n = 144), high intensity with BCS (n = 144) or low-to-moderate intensity with BCS (n = 145). The 6-month exercise intervention included supervised resistance training and home-based endurance training. CRF was assessed by Multidimensional Fatigue Inventory (MFI, five subscales score range 4-20), and Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-F, score range 0-52). Multiple linear regression for main factorial effects was performed according to intention-to-treat, with post-intervention CRF as primary endpoint. Overall, 577 participants (mean age 58.7 years) were randomized. Participants randomized to high- vs low-to-moderate-intensity exercise had lower physical fatigue (MFI Physical Fatigue subscale; mean difference -1.05 [95% CI: -1.85, -0.25]), but the difference was not clinically important (ie <2). We found no differences in other CRF dimensions and no effect of additional BCS. There were few minor adverse events. For CRF, patients undergoing (neo-)adjuvant treatment for breast, prostate or colorectal cancer can safely exercise at high- or low-to-moderate intensity, according to their own preferences. Additional BCS does not provide extra benefit for CRF in supervised, well-controlled exercise interventions.
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http://dx.doi.org/10.1111/sms.13930DOI Listing
May 2021

Development of an EORTC questionnaire measuring instrumental activities of daily living (IADL) in patients with brain tumours: phase I-III.

Qual Life Res 2021 May 26;30(5):1491-1502. Epub 2021 Jan 26.

Department of Neurology, Leiden University Medical Center, Leiden, The Netherlands.

Purpose: Being able to function independently in society is an important aspect of quality of life. This ability goes beyond self-care, requires higher order cognitive functioning, and is typically measured with instrumental activities of daily living (IADL) questionnaires. Cognitive deficits are frequently observed in brain tumour patients, however, IADL is almost never assessed because no valid and reliable IADL measure is available for this patient group. Therefore, this measure is currently being developed.

Methods: This international multicentre study followed European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group module development guidelines. Three out of four phases are completed: phases (I) generation of items, (II) construction of the item list, and (III) pre-testing. This paper reports the item selection procedures and preliminary psychometric properties of the questionnaire. Brain tumour patients (gliomas and brain metastases), their informal caregivers, and health care professionals (HCPs) were included.

Results: Phase I (n = 44 patient-proxy dyads and 26 HCPs) generated 59 relevant and important activities. In phase II, the activities were converted into items. In phase III (n = 85 dyads), the 59 items were pre-tested. Item selection procedures resulted in 32 items. Exploratory factor analysis revealed a preliminary dimensional structure consisting of five scales with acceptable to excellent internal consistency (α = 0.73-0.94) and two single items. For three scales, patients with cognitive impairments had significantly more IADL problems than patients without impairments.

Conclusion: A phase IV validation study is needed to confirm the psychometric properties of the EORTC IADL-BN32 questionnaire in a larger international sample.
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http://dx.doi.org/10.1007/s11136-020-02738-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8068708PMC
May 2021

Long-Term Morbidity and Health After Early Menopause Due to Oophorectomy in Women at Increased Risk of Ovarian Cancer: Protocol for a Nationwide Cross-Sectional Study With Prospective Follow-Up (HARMOny Study).

JMIR Res Protoc 2021 Jan 22;10(1):e24414. Epub 2021 Jan 22.

Department of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, Netherlands.

Background: BRCA1/2 mutation carriers are recommended to undergo risk-reducing salpingo-oophorectomy (RRSO) at 35 to 45 years of age. RRSO substantially decreases ovarian cancer risk, but at the cost of immediate menopause. Knowledge about the potential adverse effects of premenopausal RRSO, such as increased risk of cardiovascular disease, osteoporosis, cognitive dysfunction, and reduced health-related quality of life (HRQoL), is limited.

Objective: The aim of this study is to assess the long-term health effects of premenopausal RRSO on cardiovascular disease, bone health, cognitive functioning, urological complaints, sexual functioning, and HRQoL in women with high familial risk of breast or ovarian cancer.

Methods: We will conduct a multicenter cross-sectional study with prospective follow-up, nested in a nationwide cohort of women at high familial risk of breast or ovarian cancer. A total of 500 women who have undergone RRSO before 45 years of age, with a follow-up period of at least 10 years, will be compared with 250 women (frequency matched on current age) who have not undergone RRSO or who have undergone RRSO at over 55 years of age. Participants will complete an online questionnaire on lifestyle, medical history, cardiovascular risk factors, osteoporosis, cognitive function, urological complaints, and HRQoL. A full cardiovascular assessment and assessment of bone mineral density will be performed. Blood samples will be obtained for marker analysis. Cognitive functioning will be assessed objectively with an online neuropsychological test battery.

Results: This study was approved by the institutional review board in July 2018. In February 2019, we included our first participant. As of November 2020, we had enrolled 364 participants in our study.

Conclusions: Knowledge from this study will contribute to counseling women with a high familial risk of breast/ovarian cancer about the long-term health effects of premenopausal RRSO. The results can also be used to offer health recommendations after RRSO.

Trial Registration: ClinicalTrials.gov NCT03835793; https://clinicaltrials.gov/ct2/show/NCT03835793.

International Registered Report Identifier (irrid): DERR1-10.2196/24414.
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http://dx.doi.org/10.2196/24414DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7864779PMC
January 2021

Moderators of the effect of psychosocial interventions on fatigue in women with breast cancer and men with prostate cancer: Individual patient data meta-analyses.

Psychooncology 2020 11 3;29(11):1772-1785. Epub 2020 Sep 3.

Department of Epidemiology and Biostatistics, Amsterdam Public Health Research Institute, Amsterdam UMC, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.

Objective: Psychosocial interventions can reduce cancer-related fatigue effectively. However, it is still unclear if intervention effects differ across subgroups of patients. These meta-analyses aimed at evaluating moderator effects of (a) sociodemographic characteristics, (b) clinical characteristics, (c) baseline levels of fatigue and other symptoms, and (d) intervention-related characteristics on the effect of psychosocial interventions on cancer-related fatigue in patients with non-metastatic breast and prostate cancer.

Methods: Data were retrieved from the Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS) consortium. Potential moderators were studied with meta-analyses of pooled individual patient data from 14 randomized controlled trials through linear mixed-effects models with interaction tests. The analyses were conducted separately in patients with breast (n = 1091) and prostate cancer (n = 1008).

Results: Statistically significant, small overall effects of psychosocial interventions on fatigue were found (breast cancer: β = -0.19 [95% confidence interval (95%CI) = -0.30; -0.08]; prostate cancer: β = -0.11 [95%CI = -0.21; -0.00]). In both patient groups, intervention effects did not differ significantly by sociodemographic or clinical characteristics, nor by baseline levels of fatigue or pain. For intervention-related moderators (only tested among women with breast cancer), statistically significant larger effects were found for cognitive behavioral therapy as intervention strategy (β = -0.27 [95%CI = -0.40; -0.15]), fatigue-specific interventions (β = -0.48 [95%CI = -0.79; -0.18]), and interventions that only targeted patients with clinically relevant fatigue (β = -0.85 [95%CI = -1.40; -0.30]).

Conclusions: Our findings did not provide evidence that any selected demographic or clinical characteristic, or baseline levels of fatigue or pain, moderated effects of psychosocial interventions on fatigue. A specific focus on decreasing fatigue seems beneficial for patients with breast cancer with clinically relevant fatigue.
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http://dx.doi.org/10.1002/pon.5522DOI Listing
November 2020

Calculating the net clinical benefit in neuro-oncology clinical trials using two methods: quality-adjusted survival effect sizes and joint modeling.

Neurooncol Adv 2020 Jan-Dec;2(1):vdaa147. Epub 2020 Oct 29.

Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands.

Background: Two methods combining survival and health-related quality of life (HRQoL) data in glioma trials to calculate the "net clinical benefit" were evaluated: Quality-adjusted effect sizes (QASES) and joint modeling (JM).

Methods: The net clinical benefit in two trials was calculated as proof of concept for other trials. With the QASES method, effect sizes for differences in progression-free survival (PFS) or overall survival (OS) and HRQoL between the experimental arm and standard treatment arm were calculated, while the relative emphasis placed on survival/HRQoL varied. JM allows simultaneous modeling of HRQoL and OS/PFS.

Results: In the EORTC 26951 trial, combined radiochemotherapy significantly prolonged OS (difference 11.7 months), but also resulted in more patients experiencing clinically relevant worsening (≥10 points) in appetite loss and nausea/vomiting shortly after treatment. Using QASES, the survival benefit of additional procarbazine, lomustine, and vincristine (PCV) decreased from 42.3 months to 29.5 and 28.2 months when accounting for appetite loss and nausea/vomiting, respectively. JM analyses resulted in a loss of the beneficial effect of additional PCV between 13% and 24% when adjusting for different HRQoL parameters. The EORTC 22033 trial showed no significant PFS difference between radiotherapy or temozolomide alone (46 vs 39 months), nor clinically relevant differences in HRQoL. JM analyses also showed no significant association between PFS and HRQoL scales/items, whereas QASES showed that temozolomide alone was more favorable when considering symptom burden (47-49 instead of 39 months).

Conclusions: Both methods resulted in different outcomes, but adjusting for the impact of treatment on HRQoL resulted in theoretically reduced survival benefits.
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http://dx.doi.org/10.1093/noajnl/vdaa147DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7772555PMC
October 2020

Measuring change in health-related quality of life: the impact of different analytical methods on the interpretation of treatment effects in glioma patients.

Neurooncol Pract 2020 Dec 7;7(6):668-675. Epub 2020 Jun 7.

Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands.

Background: Different analytical methods may lead to different conclusions about the impact of treatment on health-related quality of life (HRQoL). This study aimed to examine 3 different methods to evaluate change in HRQoL and to study whether these methods result in different conclusions.

Methods: HRQoL data from 15 randomized clinical trials were combined (CODAGLIO project). Change in HRQoL scores, measured with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and BN20 questionnaires, was analyzed in 3 ways: (1) at the group level, comparing mean changes in scale/item scores between treatment arms, (2) at the patient level per scale/item, calculating the percentage of patients that deteriorated, improved, or remained stable per scale/item, and (3) at the individual patient level, combining all scales/items.

Results: Baseline and first follow-up HRQoL data were available for 3727 patients. At the group scale/item level, only the item "hair loss" showed a significant and clinically relevant change (ie, ≥10 points) over time, whereas change scores on the other scales/items were statistically significant only (all  < .001; range in change score, 0.1-6.2). Although a large proportion of patients had stable HRQoL over time (range, 27%-84%) on the patient level per scale/item, many patients deteriorated (range, 6%-43%) or improved (range, 8%-32%) on a specific scale/item. At the individual patient level, the majority of patients (86%) showed both deterioration and improvement, whereas only 1% remained stable on all scales.

Conclusions: Different analytical methods of changes in HRQoL result in distinct conclusions of treatment effects, all of which may be relevant for informing clinical decision making.
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http://dx.doi.org/10.1093/nop/npaa033DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7716184PMC
December 2020

Dutch translation and linguistic validation of the U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™).

J Patient Rep Outcomes 2020 Oct 6;4(1):81. Epub 2020 Oct 6.

Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.

Background: The U.S. National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE™) is a library of items for assessing symptomatic adverse events by patient self-report in oncology trials. The aim of this multi-site study was to generate and linguistically validate a Dutch language version of the U.S. PRO-CTCAE for use in the Netherlands and Dutch-speaking Belgium.

Methods: All 124 items in the PRO-CTCAE item library were translated into Dutch using established translation procedures, including dual forward translations, reconciliation, back-translation, reconciliation of the source with the back-translation, and expert reviews. Harmonization of the translation for use in both the Netherlands and Belgium was achieved via an iterative review process in which the translations were discussed and reconciled by consensus of PRO experts, clinicians and bilingual Dutch translators. The translated PRO-CTCAE™ items were completed by a geographically-diverse sample of Dutch speaking patients from the Netherlands (n = 40) and Belgium (n = 60), and who were currently receiving or who had recently completed cancer-directed therapy. Patients were diverse with respect to age, sex, educational attainment, and cancer diagnosis. Cognitive debriefing, using a semi-structured interview guide, probed for comprehension and clarity of PRO-CTCAE symptom terms, attributes (e.g. frequency, severity, interference), response choices, and understanding of 'at its worst' and 'in the last 7 days'. Items for which the patient data indicated possible difficulties were considered for revision.

Results: Three items underwent minor phrasing revision and retesting was not deemed necessary. The symptom term for stretch marks was poorly understood by 12.5% of participants, and this item was revised to include parenthetical phrasing. It was retested with 10 participants from Belgium (n = 5) and the Netherlands (n = 5) and demonstrated acceptable comprehension.

Conclusions: The Dutch language version of PRO-CTCAE has been successfully developed and linguistically validated for use in oncology studies in the Netherlands and Dutch-speaking Belgium. Extending the availability of NCI PRO-CTCAE in languages beyond English increases international consistency in the capture of Patient-Reported outcomes in patients participating in cancer clinical trials.
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http://dx.doi.org/10.1186/s41687-020-00249-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7538479PMC
October 2020

Depressive Symptoms in Danish Patients With Glioma and a Cancer-Free Comparison Group.

J Natl Compr Canc Netw 2020 09;18(9):1222-1229

Danish Cancer Society Research Center, Copenhagen.

Background: It is well established that patients with glioma may experience adverse general (eg, headache) or focal symptoms (eg, personality changes) and neurocognitive deficits (eg, planning), but they may also experience severe emotional distress. We investigated the prevalence of depressive symptoms in patients with newly diagnosed glioma and in matched cancer-free persons.

Methods: For this study, we recruited patients with glioma diagnosed within 12 months at all 4 neurosurgical clinics in Denmark. The cancer-free comparison group was identified through the Danish Central Person Register and matched on sex and age. Participants' depressive symptoms were evaluated using the Center for Epidemiologic Studies Depression Scale (CES-D; score range, 0-60), with a cutoff score ≥16 indicating moderate-to-severe depressive symptoms.

Results: In this study, 363 of 554 patients with glioma and 481 of 1,304 cancer-free persons participated. Mean age of all patients was 55 years and 60% of the population was male. Mean scores for depressive symptoms were statistically significantly higher among patients with glioma, with a mean CES-D score of 10.9 (95% CI, 10.1-11.8) compared with 5.3 (95% CI, 4.7-5.8) among cancer-free persons (P<.0001). Overall, 92 patients with glioma (25%) and 30 cancer-free persons (6%) had moderate-to-severe depressive symptoms. After adjustment for marital status, education level, and comorbidity, the prevalence of depressive symptoms was 5 times higher among patients with glioma compared with cancer-free persons.

Conclusions: A substantially higher prevalence of moderate-to-severe depressive symptoms was identified in patients with glioma compared with cancer-free persons. This indicates the importance of programs to systematically identify and manage depressive symptoms in patients with glioma.
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http://dx.doi.org/10.6004/jnccn.2020.7570DOI Listing
September 2020

Evaluating the Thresholds for Clinical Importance of the EORTC QLQ-C15-PAL in Patients Receiving Palliative Treatment.

J Palliat Med 2021 03 24;24(3):397-404. Epub 2020 Aug 24.

University Hospital of Psychiatry II, Medical University of Innsbruck, Innsbruck, Austria.

The EORTC QLQ-C15-PAL is a shortened version of the widely used EORTC QLQ-C30. This questionnaire was developed to measure the symptoms and functional health of patients receiving palliative care. To enhance clinical interpretability of the EORTC QLQ-C15-PAL, our aim was to evaluate the sensitivity and specificity of thresholds for clinical importance developed previously for the QLQ-C30 when applied to the QLQ-C15-PAL scales. Cross-sectional observational study. Patients with cancer receiving any type of palliative treatment. Patients completed the EORTC QLQ-C15-PAL and anchor items on limitations, worries, and need for help for each of the health domains covered by the questionnaire. The anchor items were summarized in a binary criterion for clinical importance to calculate the sensitivity and specificity of the thresholds for clinical importance. In total, 225 patients participated in the study (mean age 64.5 years). Patients were recruited from Austria, Italy, the Netherlands, Poland, Spain, and the United Kingdom. The thresholds for clinical importance for the QLQ-C15-PAL scales showed a median sensitivity of 0.88 (range: 0.82 for sleep disturbances to 1.00 for dyspnea) and a median specificity of 0.74 (range: 0.54 for dyspnea to 0.89 for constipation). The thresholds for clinical importance showed high sensitivity and mostly high specificity in identifying clinically important symptoms and functional health impairments as assessed by the QLQ-C15-PAL. These thresholds will facilitate interpretation of EORTC QLQ-C15-PAL scores in daily clinical practice and clinical research.
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http://dx.doi.org/10.1089/jpm.2020.0159DOI Listing
March 2021

Towards a cancer mission in Horizon Europe: recommendations.

Mol Oncol 2020 08;14(8):1589-1615

European Cancer Patient Coalition, Brussels, Belgium.

A comprehensive translational cancer research approach focused on personalized and precision medicine, and covering the entire cancer research-care-prevention continuum has the potential to achieve in 2030 a 10-year cancer-specific survival for 75% of patients diagnosed in European Union (EU) member states with a well-developed healthcare system. Concerted actions across this continuum that spans from basic and preclinical research through clinical and prevention research to outcomes research, along with the establishment of interconnected high-quality infrastructures for translational research, clinical and prevention trials and outcomes research, will ensure that science-driven and social innovations benefit patients and individuals at risk across the EU. European infrastructures involving comprehensive cancer centres (CCCs) and CCC-like entities will provide researchers with access to the required critical mass of patients, biological materials and technological resources and can bridge research with healthcare systems. Here, we prioritize research areas to ensure a balanced research portfolio and provide recommendations for achieving key targets. Meeting these targets will require harmonization of EU and national priorities and policies, improved research coordination at the national, regional and EU level and increasingly efficient and flexible funding mechanisms. Long-term support by the EU and commitment of Member States to specialized schemes are also needed for the establishment and sustainability of trans-border infrastructures and networks. In addition to effectively engaging policymakers, all relevant stakeholders within the entire continuum should consensually inform policy through evidence-based advice.
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http://dx.doi.org/10.1002/1878-0261.12763DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7400777PMC
August 2020

A cost-effective approach to increasing participation in patient-reported outcomes research in cancer: A randomized trial of video invitations.

Int J Cancer 2021 02 21;148(4):971-980. Epub 2020 Sep 21.

Kids Cancer Centre, Sydney Children's Hospital, Randwick, New South Wales, Australia.

Maximizing participation in cancer research is important to improve the validity and generalizability of research findings. We conducted a four-arm randomized controlled trial to test the impact of a novel video invitation on participant response. We invited childhood cancer survivors and parents of survivors <16 years to complete questionnaires. We compared response rates to an invitation letter (control) vs receiving the letter plus a video invitation on a flash drive presented by a childhood cancer survivor, a pediatric oncologist or a researcher. We explored factors associated with viewing the video and examined the impact of enclosing the USB on study costs. Overall 54% (634/1176) of questionnaires were returned. Participants who received a video invitation on a USB were more likely to return the questionnaire than those who did not (58% vs 47%, P < .001). Participation rate did not significantly differ by video presenter. Forty-seven percent of participants who received a USB reported watching the video, of whom 48% reported that the video influenced their decision to participate. Participants with a lower income (OR = 0.43, 95% CI = 0.25-0.74, P = .002) were more likely to report watching the video. Participants who received a video invitation required significantly fewer reminder calls than those who only received a written invitation (mean = 1.6 vs 1.1 calls, P < .001), resulting in a 25% recruitment cost-saving for the study. Adding a USB with a video study invitation to recruitment packages is a cost-effective way of improving study participation. This is important in an era of declining study participation and underrepresentation of vulnerable populations in research.
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http://dx.doi.org/10.1002/ijc.33244DOI Listing
February 2021

Design of the PROstate cancer follow-up care in Secondary and Primary hEalth Care study (PROSPEC): a randomized controlled trial to evaluate the effectiveness of primary care-based follow-up of localized prostate cancer survivors.

BMC Cancer 2020 Jul 8;20(1):635. Epub 2020 Jul 8.

Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute-Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066, Amsterdam, CX, The Netherlands.

Background: In its 2006 report, From cancer patient to cancer survivor: lost in transition, the U.S. Institute of Medicine raised the need for a more coordinated and comprehensive care model for cancer survivors. Given the ever increasing number of cancer survivors, in general, and prostate cancer survivors, in particular, there is a need for a more sustainable model of follow-up care. Currently, patients who have completed primary treatment for localized prostate cancer are often included in a specialist-based follow-up care program. General practitioners already play a key role in providing continuous and comprehensive health care. Studies in breast and colorectal cancer suggest that general practitioners could also consider to provide survivorship care in prostate cancer. However, empirical data are needed to determine whether follow-up care of localized prostate cancer survivors by the general practitioner is a feasible alternative.

Methods: This multicenter, randomized, non-inferiority study will compare specialist-based (usual care) versus general practitioner-based (intervention) follow-up care of prostate cancer survivors who have completed primary treatment (prostatectomy or radiotherapy) for localized prostate cancer. Patients are being recruited from hospitals in the Netherlands, and randomly (1:1) allocated to specialist-based (N = 195) or general practitioner-based (N = 195) follow-up care. This trial will evaluate the effectiveness of primary care-based follow-up, in comparison to usual care, in terms of adherence to the prostate cancer surveillance guideline for the timing and frequency of prostate-specific antigen assessments, the time from a biochemical recurrence to retreatment decision-making, the management of treatment-related side effects, health-related quality of life, prostate cancer-related anxiety, continuity of care, and cost-effectiveness. The outcome measures will be assessed at randomization (≤6 months after treatment), and 12, 18, and 24 months after treatment.

Discussion: This multicenter, prospective, randomized study will provide empirical evidence regarding the (cost-) effectiveness of specialist-based follow-up care compared to general practitioner-based follow-up care for localized prostate cancer survivors.

Trial Registration: Netherlands Trial Registry, Trial NL7068 (NTR7266). Prospectively registered on 11 June 2018.
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http://dx.doi.org/10.1186/s12885-020-07112-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7346492PMC
July 2020

Time to health-related quality of life improvement analysis was developed to enhance evaluation of modern anticancer therapies.

J Clin Epidemiol 2020 11 18;127:9-18. Epub 2020 Jun 18.

Italian Group for Adult Hematologic Diseases (GIMEMA) Data Center and Health Outcomes Research Unit, Rome, Italy; Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.

Objectives: Major advances have recently been made in the treatments of cancer, which now also have the potential to improve patients' health-related quality of life (HRQOL). We propose the time to HRQOL improvement (TTI) and the time to sustained HRQOL improvement (TTSI) as potentially important cancer outcomes to be used in longitudinal HRQOL analyses.

Study Design And Setting: As proof of principle, we defined TTI and TTSI, using the Fine-Gray model to include competing risks in estimates, in a case study in real life of a cohort of newly diagnosed patients with cancer receiving a targeted therapy. HRQOL was evaluated before and during therapy with six assessments over a 24-month period, using the well-validated European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30.

Results: For each assessed HRQOL domain, we assessed TTI and TTSI and estimated the cumulative incidence of patients' clinically meaningful improvements, also accounting for the occurrence of competing events.

Conclusion: TTI and TTSI are potentially important outcomes in the era of modern anticancer therapies. The analysis of TTI and TTSI by competing risks approach will further add to the statistical methods that can be used to inform on the impact of cancer therapies on patients' HRQOL.
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http://dx.doi.org/10.1016/j.jclinepi.2020.06.016DOI Listing
November 2020

Differences in Patient-Reported Outcomes That Are Most Frequently Detected in Randomized Controlled Trials in Patients With Solid Tumors: A Pooled Analysis of 229 Trials.

Value Health 2020 05 25;23(5):666-673. Epub 2020 Apr 25.

Italian Group for Adult Hematologic Diseases, Data Center and Health Outcomes Research Unit, Rome, Italy. Electronic address:

Objectives: Patient-reported outcome (PRO) measurements used in cancer research can assess a number of health domains. Our primary objective was to investigate which broad types of PRO domains (namely, functional health, symptoms, and global quality of life [QoL]) most frequently yielded significant differences between treatments in randomized controlled trials (RCTs).

Methods: A total of 229 RCTs published between January 2004 and February 2019, conducted on patients diagnosed with the most common solid malignancies and assessed using the European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30, were considered. Studies were identified systematically using literature searches in key electronic databases. Unlike other PRO measurements typically used in RCTs, the scoring algorithm of the multidimensional EORTC QLQ-C30 allowed us to clearly distinguish the 3 broad types of PRO domains.

Results: In total, 134 RCTs (58.5%) reported statistically significant differences between treatment arms for at least 1 of the QLQ-C30 domains. Most frequently, differences were reported for 2 or all 3 broad types of PRO domains (78 of 134 trials; 58.2%). In particular, 35 trials (26.1%) found significant differences for symptoms, functional health, and global QoL, 24 trials (17.9%) for symptoms and functional health, 11 trials (8.2%) for functional health and global QoL, and 8 trials (6.0%) for symptoms and global QoL. The likelihood of finding a statistically significant difference between treatment arms was not associated with key study characteristics, such as study design (ie, open-label vs blinded trials) and industry support.

Conclusions: Our findings emphasize the importance of a multidimensional PRO assessment to most comprehensively capture the overall burden of therapy from the patients' standpoint.
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http://dx.doi.org/10.1016/j.jval.2020.02.007DOI Listing
May 2020

Unmet expectations in prostate cancer patients and their association with decision regret.

J Cancer Surviv 2020 10 8;14(5):731-738. Epub 2020 May 8.

Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Plesmanlaan 121, 1066 CX, Amsterdam, The Netherlands.

Purpose: Information about prostate cancer patients' experiences with their treatment is crucial to optimize shared decision-making. This study examined unmet expectations in prostate cancer patients and their association with decision regret.

Methods: We conducted a prospective, observational, multi-center study of men diagnosed with localized prostate cancer between 2014 and 2016. Questionnaires were completed at baseline (pre-treatment), and up to 12 months after treatment. Unmet expectations were reported as the proportion of patients who experienced side effects as worse than expected. Linear regression analysis was used to identify factors associated significantly (p ≤ 0.05) with unmet expectations and its association with decision regret.

Results: At 1-year follow-up, the majority of the patients (71%, 210/296) reported at least one unmet expectation. The proportion of patients who reported worse than expected erectile problems was 56%, recovery period = 29%, urinary problems = 28%, fatigue = 24%, and bowel problems = 17%. Unmet expectations were comparable between treatment groups, except for fatigue. A passive role in the decision-making process (eta squared (η) = 0.02) and higher scores on the decisional conflict scale (η = 0.02) were associated with more unmet expectations, and unmet expectations were associated with decision regret (η = 0.08).

Conclusions: Unmet expectations are common among men treated for localized prostate cancer. Involving patients in the treatment decision-making process and offering additional counseling to patients who indicate uncertainty about their decision, may help to avoid unmet expectations.

Implications For Cancer Survivors: The current study emphasizes the need for involving prostate cancer patients in the decision-making process in order to mitigate unmet expectations.
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http://dx.doi.org/10.1007/s11764-020-00888-6DOI Listing
October 2020

The EORTC QLQ-C30 Summary Score as Prognostic Factor for Survival of Patients with Cancer in the "Real-World": Results from the Population-Based PROFILES Registry.

Oncologist 2020 04 31;25(4):e722-e732. Epub 2019 Oct 31.

Department of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands.

Background: Health-related quality of life (HRQoL) has been shown to be a prognostic factor for cancer survival in randomized clinical trials and observational "real-world" cohort studies; however, it remains unclear which HRQoL domains are the best prognosticators. The primary aims of this population-based, observational study were to (a) investigate the association between the novel European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core30 (QLQ-C30) summary score and all-cause mortality, adjusting for the more traditional sociodemographic and clinical prognostic factors; and (b) compare the prognostic value of the QLQ-C30 summary score with the global quality of life (QoL) and physical functioning scales of the QLQ-C30.

Materials And Methods: Between 2008 and 2015, patients with cancer (12 tumor types) were invited to participate in PROFILES disease-specific registry studies (response rate, 69%). In this secondary analysis of 6,895 patients, multivariate Cox proportional hazard regression models were used to investigate the association between the QLQ-C30 scores and all-cause mortality.

Results: In the overall Cox regression model including sociodemographic and clinical variables, the QLQ-C30 summary score was associated significantly with all-cause mortality (hazard ratio [HR], 0.77; 99% confidence interval [CI], 0.71-0.82). In stratified analyses, significant associations between the summary score and all-cause mortality were observed for colon, rectal, and prostate cancer, non-Hodgkin lymphoma, chronic lymphocytic leukemia, and multiple myeloma. The QLQ-C30 summary score had a stronger association with all-cause mortality than the global QoL scale (HR, 0.82; 99% CI, 0.77-0.86) or the physical functioning scale (HR, 0.81; 95% CI, 0.77-0.85).

Conclusion: In a real-world setting, the QLQ-C30 summary score has a strong prognostic value for overall survival for a number of populations of patients with cancer above and beyond that provided by clinical and sociodemographic variables. The QLQ-C30 summary score appears to have more prognostic value than the global QoL, physical functioning, or any other scale within the QLQ-C30.

Implications For Practice: The finding that health-related quality of life provides distinct prognostic information beyond known sociodemographic and clinical measures, not only around cancer diagnosis (baseline) but also at follow-up, has implications for clinical practice. Implementation of cancer survivorship monitoring systems for ongoing surveillance may improve post-treatment rehabilitation that leads to better outcomes.
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http://dx.doi.org/10.1634/theoncologist.2019-0348DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7160310PMC
April 2020

Education Needs of Dutch Physical Therapists for the Treatment of Patients With Advanced Cancer: A Mixed Methods Study.

Phys Ther 2020 03;100(3):477-486

Center for Quality of Life, The Netherlands Cancer Institute, Plesmanlaan 121, Amsterdam 1066cx, The Netherlands; Amsterdam Movement Sciences, Department of Rehabilitation, Amsterdam UMC, VU Medical Center; and ACHIEVE, Faculty of Health, University of Applied Sciences Amsterdam, Amsterdam, The Netherlands.

Background: The survival rates for patients with advanced cancer have increased over time. Many patients experience symptoms and functional limitations that impair activities of daily living and limit quality of life. A number of these health problems are amenable to physical therapist treatment. However, physical therapists caring for patients with advanced cancer require special training and skills.

Objective: The study aimed to assess the educational needs and clinical uncertainties of Dutch physical therapists in relation to treatment of patients with advanced cancer.

Design: This was a mixed methods study.

Methods: A survey and 2 focus groups were conducted among physical therapists working in primary care who had previously received at least basic oncology training.

Results: A total of 162 physical therapists completed the survey. The most frequently reported educational needs were related to effective interprofessional collaboration (61.7%), knowledge of medical treatment (49.4%), and current evidence on physical therapist interventions in this population (49.4%). In the focus groups, physical therapists (n = 17) voiced uncertainties about treating patients with bone metastases, setting realistic goals, when and how to end a treatment episode, interprofessional collaboration, finding and using evidence, and using clinimetrics.

Conclusion: These results support the need for specific education programs for physical therapists working with advanced cancer patients to increase the availability of high-quality oncology rehabilitation for this population.
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http://dx.doi.org/10.1093/ptj/pzz172DOI Listing
March 2020

International validation of the EORTC CAT Core: a new adaptive instrument for measuring core quality of life domains in cancer.

Qual Life Res 2020 May 18;29(5):1405-1417. Epub 2020 Jan 18.

The Research Unit, Department of Palliative Medicine, Bispebjerg & Frederiksberg Hospital, University of Copenhagen, Bispebjerg bakke 23B, 2400, Copenhagen NV, Denmark.

Background: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group (QLG) has developed computerised adaptive tests (CATs) for the 14 functional and symptom domains of the EORTC QLQ-C30 quality of life questionnaire. This is expected to optimise measurement precision, relevance to patients and flexibility. Here, we present the first international validation of the EORTC CAT Core.

Methods: A heterogeneous sample of 699 cancer patients scheduled for chemotherapy and/or radiotherapy was recruited across seven European countries. The EORTC CAT Core and all QLQ-C30 items were administered to participants before and after initiating treatment. Correlations between CAT and QLQ-C30 scores and floor/ceiling effects were calculated. Using several grouping variables, relative validity (cross-sectional known groups difference), responsiveness (changes over time) and relative sample size requirements of the CAT compared to the QLQ-C30 were estimated.

Results: Correlations of the CAT and QLQ-C30 ranged from 0.81 to 0.93 across domains. The mean relative reduction in floor and ceiling effects using the CAT was 42% (range 3-99%). Analyses of known groups validity and responsiveness indicated that, across domains, mean sample size requirements for the CAT were 72% and 70%, respectively, of those using the QLQ-C30.

Conclusions: The EORTC CAT Core measures the same domains as the QLQ-C30 with reduced floor/ceiling effects. The CAT generally facilitated the use of smaller samples (about 30% smaller on average) without loss of power compared to the QLQ-C30. Based on this study, the EORTC QLG will release the EORTC CAT Core for general use.
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http://dx.doi.org/10.1007/s11136-020-02421-9DOI Listing
May 2020

Health-related quality of life in adult patients with brain metastases after stereotactic radiosurgery: a systematic, narrative review.

Support Care Cancer 2020 Feb 2;28(2):473-484. Epub 2019 Dec 2.

Department of Neurosurgery, Elisabeth-TweeSteden Hospital, Hilvarenbeekseweg 60, 5022 GC, Tilburg, The Netherlands.

Purpose: A growing number of patients with brain metastases (BM) are being treated with stereotactic radiosurgery (SRS), and the importance of evaluating the impact of SRS on the health-related quality of life (HRQoL) in these patients has been increasingly acknowledged. This systematic review summarizes the current knowledge about the HRQoL of patients with BM after SRS.

Methods: We searched EMBASE, Medline Ovid, Web-of-Science, the Cochrane Database, PsycINFO Ovid, and Google Scholar up to November 15, 2018. Studies in patients with BM in which HRQoL was assessed before and after SRS and analyzed over time were included. Studies including populations of several types of brain cancer and/or several types of treatments were included if the results for patients with BM and treatment with SRS alone were described separately.

Results: Out of 3638 published articles, 9 studies met the eligibility criteria and were included. In 4 out of 7 studies on group results, overall HRQoL of patients with BM remained stable after SRS. In small study samples of longer-term survivors, overall HRQoL remained stable up to 12 months post-SRS. Contradictory results were reported for physical and general/global HRQoL, which might be explained by the different questionnaires that were used.

Conclusions: In general, SRS does not have significant negative effects on patients' overall HRQoL over time. Future research is needed to analyze different aspects of HRQoL, differences in individual changes in HRQoL after SRS, and factors that influence these changes. These studies should take into account several methodological issues as discussed in this review.
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http://dx.doi.org/10.1007/s00520-019-05136-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6954134PMC
February 2020

Internet-based cognitive behavioral therapy aimed at alleviating treatment-induced menopausal symptoms in breast cancer survivors: Moderators and mediators of treatment effects.

Maturitas 2020 Jan 18;131:8-13. Epub 2019 Sep 18.

Division of Psychosocial Research and Epidemiology, The Netherlands Cancer Institute, Amsterdam, The Netherlands. Electronic address:

Objectives: Results from our recently conducted randomized controlled trial (RCT) indicated that Internet-based cognitive behavioral therapy (iCBT), with or without therapist support, is effective in reducing the perceived impact of hot flushes and night sweats (HF/NS) and overall levels of menopausal symptoms in breast cancer survivors with treatment-induced menopausal symptoms.

Study Design: We used data of 235 women and compared the iCBT groups combined (n = 156) with the control group (n = 79). Bootstrapped multiple regression analyses with interaction terms (group x potential moderator) or indirect effects (mediation pathway) were conducted.

Main Outcome Measures: Reductions in perceived impact of HF/NS and overall levels of menopausal symptoms.

Results: Women with lower levels of education benefited most from the iCBT. Age, time since diagnosis, current endocrine treatment, oophorectomy, frequency of HF/NS, and psychological distress did not moderate the treatment effects. Factors that mediated treatment effects were the development of healthier beliefs about experiencing hot flushes in a social context, about the impact of night sweats on sleep and daily functioning, and about the ability to control and cope with hot flushes. The acquisition of behavioral coping strategies and decreased psychological distress did not mediate treatment effects.

Conclusion: The results suggest that women with lower levels of education may benefit most from the current iCBT program, with or without therapist support. The development of healthier HF/NS beliefs contribute significantly to the observed positive effect of iCBT on the burden of menopausal symptoms.

Clinical Trial Information: NCT02672189.
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http://dx.doi.org/10.1016/j.maturitas.2019.09.007DOI Listing
January 2020

Risk factors of unmet needs among women with breast cancer in the post-treatment phase.

Psychooncology 2020 03 16;29(3):539-549. Epub 2019 Dec 16.

Academic Medical Center, Cancer Center Amsterdam, Amsterdam University Medical Centers, Amsterdam, The Netherlands.

Objective: Unmet health care needs require additional care resources to achieve optimal patient well-being. In this nationwide study we examined associations between a number of risk factors and unmet needs after treatment among women with breast cancer, while taking into account their health care practices. We expected that more care use would be associated with lower levels of unmet needs.

Methods: A multicenter, prospective, observational design was employed. Women with primary breast cancer completed questionnaires 6 and 15 months post-diagnosis. Medical data were retrieved from medical records. Direct and indirect associations between sociodemographic and clinical risk factors, distress, care use, and unmet needs were investigated with structural equation modeling.

Results: Seven hundred forty-six participants completed both questionnaires (response rate 73.7%). The care services received were not negatively associated with the reported levels of unmet needs after treatment. Comorbidity was associated with higher physical and daily living needs. Higher age was associated with higher health system-related and informational needs. Having had chemotherapy and a mastectomy were associated with higher sexuality needs and breast cancer-specific issues, respectively. A higher level of distress was associated with higher levels of unmet need in all domains.

Conclusions: Clinicians may use these results to timely identify which women are at risk of developing specific unmet needs after treatment. Evidence-based, cost-effective (online) interventions that target distress, the most influential risk factor, should be further implemented and disseminated among patients and clinicians.
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http://dx.doi.org/10.1002/pon.5299DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7065096PMC
March 2020

Consistency matters: measurement invariance of the EORTC QLQ-C30 questionnaire in patients with hematologic malignancies.

Qual Life Res 2020 Mar 28;29(3):815-823. Epub 2019 Nov 28.

Data Center and Health Outcomes Research Unit, Italian Group for Adult Hematologic Diseases (GIMEMA), Rome, Italy.

Purpose: To ensure that observed differences in the scores of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) reflect actual differences in health-related quality of life (HRQoL) rather than measurement bias, measurement invariance needs to be established. We investigated the assumption of measurement invariance of the EORTC QLQ-C30 in patients with hematological malignancies across age, sex, comorbidity, disease type, and time.

Methods: We used a large database of patients with hematological malignancies, which included HRQoL data collected with the EORTC QLQ-C30. We used the structural equation modeling approach to test for measurement (metric and scalar) invariance across groups (age, sex, comorbidity, disease) and time (baseline, 1 month and 2 month follow-up). Longitudinal invariance was examined in a subgroup of patients diagnosed with myelodysplastic syndromes.

Results: Confirmatory factor analyses demonstrated full measurement invariance for age and comorbidity and over time, while support for partial scalar invariance was obtained for sex and disease. Violations of invariance for sex were observed for items of the physical functioning scale and the emotional functioning scale, while for disease type, violations of invariance were observed for items of the physical functioning scale, emotional functioning scale, and the cognitive functioning scale.

Conclusions: Our findings support measurement invariance of the EORTC QLQ-C30 in a large sample of patients with hematological malignancies. The results showed that the number of non-invariant items was negligible, suggesting that this questionnaire is a valid and robust measurement tool in patients with hematological malignancies, also for comparisons across groups and time.
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http://dx.doi.org/10.1007/s11136-019-02369-5DOI Listing
March 2020
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