Publications by authors named "Neil K Aaronson"

243 Publications

Patient-reported Outcomes Following Treatment of Localised Prostate Cancer and Their Association with Regret About Treatment Choices.

Eur Urol Oncol 2020 02 26;3(1):21-31. Epub 2018 Dec 26.

Department of Urology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands. Electronic address:

Background: Well-documented reports of patients' experiences with different treatments are important for helping localised prostate cancer (LPC) patients choose among the available treatment options.

Objective: To document differences in patient-reported outcomes (PROs) following radical prostatectomy (RP), external beam radiotherapy (EBRT), brachytherapy (BT), and active surveillance (AS), and to evaluate how these PROs and other factors are associated with treatment decision regret.

Design, Setting, And Participants: A prospective, observational, multicentre study of men diagnosed with LPC (stage cT1-2) during 2014-2016.

Outcome Measurements And Statistical Analysis: Patients completed validated PRO measures (Quality of Life Questionnaire Core 30 [QLQ-C30], Quality of Life Questionnaire prostate cancer-specific module [QLQ-PR25], Decision Regret Scale, and the Memorial Anxiety Scale for Prostate Cancer) before treatment and at 3, 6, and 12mo after treatment. Mixed-effect models were used to describe different PRO patterns.

Results And Limitations: The analytic cohort included 434 men (AS=32%; RP=45%; EBRT=12%; BT=10%). Follow-up response rates were above 90%. At 1-yr follow-up, (1) men who had received RP reported significantly (p<0.01) more urinary incontinence, sexual dysfunction, hormonal/masculinity-related symptoms, and less emotional distress; (2) those having received EBRT reported more sexual dysfunction, hormonal/masculinity-related symptoms, and physical distress; and (3) those having received BT reported more urinary obstruction and irritation symptoms, compared with patients under AS. Irrespective of the treatment modality, 23% of the patients reported clinically relevant treatment regret (99% confidence interval, 17-28%). Multivariate correlates of decision regret were hormonal/masculinity-related symptoms, educational level, and positive surgical margins.

Conclusions: Post-treatment physical and psychosocial functioning was significantly associated with specific treatment modalities and pretreatment functioning. Regret was relatively frequently reported by patients who experienced unwanted physical, psychosocial, and oncological outcomes. Greater efforts should be made to understand whether carefully educating patients about the possible consequences and effectiveness of treatments may help limit the feeling of treatment regret.

Patient Summary: In men with localised prostate cancer, regret about the treatment choice was more common among those who experienced more treatment-related symptoms during the year after treatment.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.euo.2018.12.004DOI Listing
February 2020

Adherence to and satisfaction with low-intensity physical activity and supervised moderate-high intensity exercise during chemotherapy for breast cancer.

Support Care Cancer 2020 May 8;28(5):2115-2126. Epub 2019 Aug 8.

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

Purpose: In this study, we investigated factors associated with program adherence and patient satisfaction with a home-based physical activity program (Onco-Move, N = 77) and a supervised exercise program with a home-based component (OnTrack, N = 76).

Methods: We assessed adherence via self-report (home-based program) and attendance records (supervised program). We used logistic regression analysis to identify sociodemographic, clinical and behavioural variables associated with program adherence. Patient satisfaction was assessed with self-report and is reported descriptively.

Results: Fifty-one percent of Onco-Move and 62% of OnTrack participants were adherent to the home-based program, while 59% of OnTrack participants were adherent to the supervised sessions. Higher baseline physical fitness was associated with higher adherence to home-based components. Higher disease stage and having a partner were associated with adherence to OnTrack supervised sessions. Overall satisfaction with the exercise programs was high, but ratings of coaching provided by professionals for the home-based components were low. Patients offered suggestions for improving delivery of the programs.

Conclusions: These findings point to factors relevant to program adherence and suggest ways in which such programs can be improved. Providing additional time and training for health care professionals could improve the quality and hopefully the effectiveness of the interventions. The use of online diaries and smartphone apps may provide additional encouragement to participants. Finally, allowing greater flexibility in the planning and availability of supervised exercise training in order to accommodate the variability in cancer treatment schedules and the (acute) side effects of the treatments could also enhance program adherence.

Trial Registration: Netherlands Trial Register, NTR2159. http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2159.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s00520-019-05019-1DOI Listing
May 2020

Cost Effectiveness of Interval Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy in Stage III Ovarian Cancer on the Basis of a Randomized Phase III Trial.

J Clin Oncol 2019 08 28;37(23):2041-2050. Epub 2019 Jun 28.

1The Netherlands Cancer Institute, Amsterdam, the Netherlands.

Purpose: In the randomized open-label phase III OVHIPEC trial, the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery (CRS) improved recurrence-free and overall survival in patients with stage III ovarian cancer. We studied the cost effectiveness of the addition of HIPEC to interval CRS in patients with ovarian cancer.

Patients And Methods: We constructed a Markov health-state transition model to measure costs and clinical outcomes. Transition probabilities were derived from the OVHIPEC trial by fitting survival distributions. Incremental cost-effectiveness ratio (ICER), expressed as euros per quality-adjusted life-year (QALY), was calculated from a Dutch societal perspective, with a time horizon of 10 years. Univariable and probabilistic sensitivity analyses were conducted to evaluate the decision uncertainty.

Results: Total health care costs were €70,046 (95% credibility interval [CrI], €64,016 to €76,661) for interval CRS compared with €85,791 (95% CrI, €78,766 to €93,935) for interval CRS plus HIPEC. The mean QALY in the interval CRS group was 2.12 (95% CrI, 1.66 to 2.64 QALYs) and 2.68 (95% CrI, 2.11 to 3.28 QALYs) in the interval CRS plus HIPEC group. The ICER amounted to €28,299/QALY. In univariable sensitivity analysis, the utility of recurrence-free survival and the number of days in the hospital affected the calculated ICER most.

Conclusion: On the basis of the trial data, treatment with interval CRS and HIPEC in patients with stage III ovarian cancer was accompanied by a substantial gain in QALYs. The ICER is below the willingness-to-pay threshold in the Netherlands, indicating interval CRS and HIPEC is cost effective for this patient population. These results lend additional support for reimbursing the costs of treating these patients with interval CRS and HIPEC in countries with comparable health care systems.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1200/JCO.19.00594DOI Listing
August 2019

The added value of health-related quality of life as a prognostic indicator of overall survival and progression-free survival in glioma patients: a meta-analysis based on individual patient data from randomised controlled trials.

Eur J Cancer 2019 07 13;116:190-198. Epub 2019 Jun 13.

Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands; Department of Neurology, Haaglanden Medical Center, Den Haag, the Netherlands.

Objective: Prognostic value of health-related quality of life (HRQoL) data may be important to inform patients in clinical practice and to guide clinical decision-making. Our study investigated the added prognostic value of HRQoL for overall survival (OS) and progression-free survival (PFS) in a large heterogeneous sample of glioma patients, besides known prognostic factors.

Methods: We included individual baseline data from previously published randomised controlled trials (RCTs) in glioma patients in which HRQoL was assessed through the European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-BN20 questionnaires. Multivariable Cox regression models (stratified for newly diagnosed versus recurrent disease) were constructed, first with clinical variables (age, sex, tumour type, performance status, allocated treatment and extent of resection) only and subsequently with HRQoL variables added, separately for OS and PFS. The added prognostic value of HRQoL was calculated using C-indices.

Results: Baseline HRQoL and clinical data from 15 RCTs were included, comprising 5217 patients. In the model including both clinical and HRQoL variables, better cognitive and role functioning and less motor dysfunction were independently associated with longer OS, whereas better role and cognitive functioning, less nausea and vomiting and more appetite loss were independently associated with prolonged PFS. However, C-indices indicated only a small prognostic improvement of the models for OS and PFS when adding HRQoL to the clinical prognostic variables (+1.1% for OS and +.7% for PFS).

Conclusion: Our findings demonstrate that several baseline HRQoL variables are independently prognostic for OS and PFS, yet the added value of HRQoL to the known clinical prognostic variables was small.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ejca.2019.05.012DOI Listing
July 2019

The International Index of Erectile Function (IIEF)-A Systematic Review of Measurement Properties.

J Sex Med 2019 07 27;16(7):1078-1091. Epub 2019 May 27.

Vrije Universiteit Amsterdam, Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Cancer Center Amsterdam, Amsterdam, The Netherlands; Amsterdam UMC, Vrije Universiteit Amsterdam, Department of Otolaryngology Head and Neck Surgery, Cancer Center Amsterdam, Amsterdam, The Netherlands. Electronic address:

Introduction: The International Index of Erectile Function (IIEF) is a patient-reported outcome measure to evaluate erectile dysfunction and other sexual problems in men.

Aim: To perform a systematic review of the measurement properties of the 15-item patient-reported outcome measure (IIEF-15) and the shortened 5-item version (IIEF-5).

Methods: A systematic search of scientific literature up to April 2018 was performed. Data were extracted and analyzed according to COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines for structural validity, internal consistency, reliability, measurement error, hypothesis testing for construct validity, and responsiveness. Evidence of measurement properties was categorized into sufficient, insufficient, inconsistent, or indeterminate, and quality of evidence as very high, high, moderate, or low.

Results: 40 studies were included. The evidence for criterion validity (of the Erectile Function subscale), and responsiveness of the IIEF-15 was sufficient (high quality), but inconsistent (moderate quality) for structural validity, internal consistency, construct validity, and test-retest reliability. Evidence for structural validity, test-retest reliability, construct validity, and criterion validity of the IIEF-5 was sufficient (moderate quality) but indeterminate for internal consistency, measurement error, and responsiveness.

Clinical Implications: Lack of evidence for and evidence not supporting some of the measurement properties of the IIEF-15 and IIEF-5 shows the importance of further research on the validity of these questionnaires in clinical research and clinical practice.

Strengths & Limitations: A strength of the current review is the use of predefined guidelines (COSMIN). A limitation of this review is the use of a precise rather than a sensitive search filter regarding measurement properties to identify studies to be included.

Conclusion: The IIEF requires more research on structural validity (IIEF-15), internal consistency (IIEF-15 and IIEF-5), construct validity (IIEF-15), measurement error (IIEF-15 and IIEF-5), and responsiveness (IIEF-5). The most pressing matter for future research is determining the unidimensionality of the IIEF-5 and the exact factor structure of the IIEF-15. Neijenhuijs KI, Holtmaat K, Aaronson NK, et al. The International Index of Erectile Function (IIEF)-A Systematic Review of Measurement Properties. J Sex Med 2019;16:1078-1091.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jsxm.2019.04.010DOI Listing
July 2019

"I am busy surviving" - Views about physical exercise in older adults scheduled for colorectal cancer surgery.

J Geriatr Oncol 2020 04 20;11(3):444-450. Epub 2019 May 20.

Center for Quality of Life, The Netherlands Cancer Institute Amsterdam, the Netherlands; ACHIEVE Center for Applied Research, University of Applied Sciences Amsterdam, Amsterdam, the Netherlands.

Objective: Seventy percent of patients with colorectal cancer (CRC) are aged 65 years or older. Netherlands Comprehensive Cancer Organization (n.d.) [1] Surgery is an important treatment modality, depending on cancer stage and the resectability of the tumor. Frail older patients are at an increased risk for complications and reduced self-care capacity after surgery. Increasing physical fitness preoperatively (prehabilitation) might improve treatment outcomes, but challenges remain with regard to uptake, attrition, and non-compliance. The objectives of this study were to investigate the barriers, facilitators, and preferences for preoperative exercise programs in older patients scheduled for CRC surgery.

Methods: This was a qualitative study, using in-depth interviews of fifteen patients aged 65 years and older and surgically treated for CRC, thirteen informal care givers (ICs) and nine health care providers (HCPs) with experience in prehabilitation. Data analysis was done through thematic coding analysis.

Results: Limited time, not receiving or misunderstanding information, physical ailments, and emotional impact of the diagnosis are barriers to preoperative exercise. Not having physical complaints (Patients, ICs, HCPs), understandable information provided by a physician (Patients, ICs), and low cost programs (ICs, HCPs) facilitate exercise. Exercise should not be too intensive (Patients, ICs) and should be adjusted to personal preferences and be provided close to home (Patients, ICs, HCPs).

Conclusions: To engage frail older adults with CRC in preoperative exercise programs information on exercise should improve. Exercise programs should be easily accessible and take personal preferences, needs and abilities into account.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jgo.2019.05.001DOI Listing
April 2020

Determinants of satisfactory patient communication and shared decision making in patients with multiple myeloma.

Psychooncology 2019 07 31;28(7):1490-1497. Epub 2019 May 31.

Department of Nursing, School of Health and Welfare, Jönköping University, Jönköping, Sweden.

Objective: To identify determinants of shared decision making in patients with multiple myeloma (MM) to facilitate the design of a program to maximize the effects of shared decision making.

Methods: This prospective longitudinal study recruited 276 adult patients (52% male, mean age 62.86 y, SD 15.45). Each patient completed the eHealth Literacy Scale (eHEALS), Multidimensional Trust in Health Care Systems Scale (MTHCSS), Patient Communication Pattern Scale (PCPS), and 9-Item Shared Decision-Making Questionnaire (SDM-Q-9) at baseline and the SDM-Q-9 again 6 months later. One family member of the patient completed the Family Decision-Making Self-Efficacy (FDMSE) at baseline. Structural equation modeling (SEM) was used to investigate the associations between eHealth literacy (eHEALS), trust in the health care system (MTHCSS), self-efficacy in family decision making (FDMSE), patient communication pattern (PCPS), and shared decision making (SDM-Q-9).

Results: SEM showed satisfactory fit (comparative fit index = 0.988) and significant correlations between the following: eHealth literacy and trust in the health care system (β = 0.723, P < 0.001); eHealth literacy and patient communication pattern (β = 0.242, P < 0.001); trust in the health care system and patient communication pattern (β = 0.397, P < 0.001); self-efficacy in family decision making and patient communication pattern (β = 0.264, P < 0.001); eHealth literacy and shared decision making (β = 0.267, P < 0.001); and patient communication pattern and shared decision making (β = 0.349, P < 0.001).

Conclusions: Patient communication and eHealth literacy were found to be important determinants of shared decision making. These factors should be taken into consideration when developing strategies to enhance the level of shared decision making.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/pon.5105DOI Listing
July 2019

Measuring health-related quality of life in colorectal cancer patients: systematic review of measurement properties of the EORTC QLQ-CR29.

Support Care Cancer 2019 Jul 13;27(7):2395-2412. Epub 2019 Apr 13.

Department of Clinical, Neuro- and Developmental Psychology, Faculty of Behavioral and Movement Sciences, Amsterdam Public Health institute, Vrije Universiteit Amsterdam, Van der Boechorststraat 7, 1081 BT, Amsterdam, The Netherlands.

Introduction: The EORTC QLQ-CR29 is a patient-reported outcome measure to evaluate health-related quality of life among colorectal cancer patients in research and clinical practice. The aim of this systematic review was to investigate whether the initial positive results regarding the measurement properties of the QLQ-CR29 are confirmed in subsequent studies.

Methods: A systematic search of Embase, Medline, PsycINFO, and Web of Science was conducted to identify studies investigating the measurement properties of the QLQ-CR29 published up to January 2019. For the 11 included studies, data were extracted, methodological quality was assessed, results were synthesized, and evidence was graded according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology on the measurement properties: structural validity, internal consistency, reliability, measurement error, construct validity (hypothesis testing, including known-group comparison, convergent and divergent validity), cross-cultural validity, and responsiveness.

Results: Internal consistency was rated as "sufficient," with low evidence. Reliability was rated as "insufficient," with moderate evidence. Construct validity (hypothesis testing; known-group comparison, convergent and divergent validity) was rated as "inconsistent," with moderate evidence. Structural validity, measurement error, and responsiveness were rated as "indeterminate" and could therefore not be graded.

Conclusion: This review indicates that current evidence supporting the measurement properties of the QLQ-CR29 is limited. Additionally, better quality research is needed, taking into account the COSMIN methodology.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s00520-019-04764-7DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6541702PMC
July 2019

The Female Sexual Function Index (FSFI)-A Systematic Review of Measurement Properties.

J Sex Med 2019 05 5;16(5):640-660. Epub 2019 Apr 5.

Vrije Universiteit Amsterdam, Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands; Amsterdam UMC, Cancer Center Amsterdam, Amsterdam, The Netherlands; Amsterdam UMC, Department of Otolaryngology-Head and Neck Surgery, Amsterdam Public Health Research Institute, Amsterdam, The Netherlands. Electronic address:

Introduction: The Female Sexual Function Index (FSFI) is a patient-reported outcome measure measuring female sexual dysfunction. The FSFI-19 was developed with 6 theoretical subscales in 2000. In 2010, a shortened version became available (FSFI-6).

Aim: To investigate the measurement properties of the FSFI-19 and FSFI-6.

Methods: A systematic search was performed of Embase, Medline, and Web of Science for studies that investigated measurement properties of the FSFI-19 or FSFI-6 up to April 2018. Data were extracted and analyzed according to COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) guidelines. Evidence was categorized into sufficient, insufficient, inconsistent, or indeterminate, and quality of evidence as very high, high, moderate, or low.

Main Outcome Measures: The Main Outcome Measure is the evidence of a measurement property, and the quality of evidence based on the COSMIN guidelines.

Results: 83 studies were included. Concerning the FSFI-19, the evidence for internal consistency was sufficient and of moderate quality. The evidence for reliability was sufficient but of low quality. The evidence for criterion validity was sufficient and of high quality. The evidence for structural validity was inconsistent of low quality. The evidence for construct validity was inconsistent of moderate quality. Concerning the FSFI-6, the evidence for criterion validity was sufficient of moderate quality. The evidence for internal consistency was rated as indeterminate. The evidence for reliability was inconsistent of low quality. The evidence for construct validity was inconsistent of very low quality. No information was available on structural validity of the FSFI-6, and measurement error, responsiveness, and cross-cultural validity of both FSFI-6 and FSFI-19.

Clinical Implications: Conflicting and lack of evidence for some of the measurement properties of the FSFI-19 and FSFI-6 indicates the importance of further research on the validity of these patient-reported outcome measures. We advise researchers who use the FSFI-19 to perform confirmatory factor analyses and report the factor structure found in their sample. Regardless of these concerns, the FSFI-19 and FSFI-6 have strong criterion validity. Pragmatically, they are good screening tools for the current definition of female sexual dysfunction.

Strength & Limitation: A strong point of the review is the use of predefined guidelines. A limitation is the use of a precise rather than a sensitive search filter.

Conclusions: The FSFI requires more research on structural validity (FSFI-19 and FSFI-6), reliability (FSFI-6), construct validity (FSFI-19), measurement error (FSFI-19 and FSFI-6), and responsiveness (FSFI-19 and FSFI-6). Further corroboration of measurement invariance (both across cultures and across subpopulations) in the factor structure of the FSFI-19 is necessary, as well as tests for the unidimensionality of the FSFI-6. Neijenhuijs KI, Hooghiemstra N, Holtmaat K, et al. The Female Sexual Function Index (FSFI)-A Systematic Review of Measurement Properties. J Sex Med 2019;16:640-660.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.jsxm.2019.03.001DOI Listing
May 2019

Changes in employment status, barriers to, and facilitators of (return to) work in breast cancer survivors 5-10 years after diagnosis.

Disabil Rehabil 2020 10 23;42(21):3052-3058. Epub 2019 Mar 23.

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

To qualitatively investigate changes in employment status, barriers to and facilitators of (return to) work in breast cancer survivors 5-10 years after diagnosis. Women were eligible to participate in the focus groups if they were younger than 55 years and were employed at time of diagnosis. Data were analysed by two independent researchers using thematic content analysis. Nineteen women participated in three semi-structured focus groups, of whom 18 reported a change in employment status 5-10 years after diagnosis. Perceived barriers to (return to) work shortly after breast cancer diagnosis tended to be disease- and treatment-related, while 5-10 years later, they were personal- and work-related. Participants recommended open communication and support at the workplace, and comprehensive information from (occupational) health care professionals to facilitate dealing with breast cancer at work. Breast cancer survivors still experience changes in employment status 5-10 years after diagnosis. (Occupational) health care professionals should be alert that perceived barriers for returning to work change over time. Future research should focus on increasing awareness (at work) of breast cancer survivors' needs, providing adequate information and support to all involved, and developing interventions to sustain survivors' work ability at the long term.IMPLICATIONS FOR REHABILITATIONEven long after diagnosis and treatment, a sizeable number of breast cancer survivors report a change in employment status, such as job loss.(Occupational) health care professionals should be alert that barriers for returning to work and retaining work change over time.There is a lack of awareness and a shortage of interventions regarding work-related issues for breast cancer survivors at long-term follow-up.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1080/09638288.2019.1583779DOI Listing
October 2020

Patients choose certainty over burden in bladder cancer surveillance.

World J Urol 2019 Dec 23;37(12):2747-2753. Epub 2019 Mar 23.

Department of Complex Genetics, Nutrition and Metabolism in Translational Research (NUTRIM), Care and Public Health Research Institute (CAPHRI), Maastricht University, Maastricht, The Netherlands.

Background: Due to the high risk of recurrence of non-muscle invasive bladder cancer, all patients undergo regular cystoscopic surveillance for early detection. As cystoscopy is invasive, costly and increases the burden of the disease considerably, there is significant ongoing research and development into non-invasive urinary biomarker substitutes. This study aims to assess the level of sensitivity required before patients accept a new urinary biomarker.

Methods: We studied the preferences for a hypothetical diagnostic urinary biomarker and compared this to usual care (cystoscopy) at different levels of sensitivity among 437 patients with bladder cancer (354 men and 83 women) from the UK Bladder Cancer Prognosis Programme. A standard gamble approach was used to estimate the minimally acceptable sensitivity (MAS) of the new biomarker. Additionally, non-parametric statistical analyses were performed to investigate the association between surveillance preference and various patient characteristics.

Results: Almost half of patients (183, 43%) would not replace cystoscopy with a urinary biomarker unless it was 100% sensitive. The median MAS was 99.9999%, and nearly 85% of patients demanded a sensitivity of at least 99% before preferring a urinary biomarker test over cystoscopy. These results were consistent across all patient characteristics and demographic categories.

Conclusions: Our results indicate that patients demand urinary biomarkers as sensitive as cystoscopy before they would be willing to forego cystoscopy for bladder cancer surveillance.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s00345-019-02728-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6867982PMC
December 2019

Clinician-reported symptomatic adverse events in cancer trials: are they concordant with patient-reported outcomes?

J Comp Eff Res 2019 04 6;8(5):279-288. Epub 2019 Mar 6.

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

Aim: We investigate the concordance, in terms of favoring the same treatment arm, between clinician-reported symptomatic adverse events (AEs) and information obtained via patient-reported outcomes (PRO) measures in cancer randomized controlled trials (RCTs).

Methods: We conducted a systematic literature search to identify all RCTs conducted in breast, colorectal, lung and prostate cancer, published between 2004 and 2017.

Results: We identified 207 RCTs. In the majority of RCTs (n=133, 64.2%) a discordance between PROs and AEs was found. In 104 studies (50.2%), PRO data favored the experimental arm when AEs did not, while the opposite situation was found in 29 trials (14.0%).

Conclusion: Frequently, information obtained via PRO measures and clinician-reported AEs do not favor the same treatment arm in RCT settings.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2217/cer-2018-0092DOI Listing
April 2019

Efficacy of Internet-Based Cognitive Behavioral Therapy for Treatment-Induced Menopausal Symptoms in Breast Cancer Survivors: Results of a Randomized Controlled Trial.

J Clin Oncol 2019 04 14;37(10):809-822. Epub 2019 Feb 14.

1 The Netherlands Cancer Institute, Amsterdam, the Netherlands.

Purpose: We evaluated the effect of Internet-based cognitive behavioral therapy (iCBT), with or without therapist support, on the perceived impact of hot flushes and night sweats (HF/NS) and overall levels of menopausal symptoms (primary outcomes), sleep quality, HF/NS frequency, sexual functioning, psychological distress, and health-related quality of life in breast cancer survivors with treatment-induced menopausal symptoms.

Patients And Methods: We randomly assigned 254 breast cancer survivors to a therapist-guided or a self-managed iCBT group or to a waiting list control group. The 6-week iCBT program included psycho-education, behavior monitoring, and cognitive restructuring. Questionnaires were administered at baseline and at 10 weeks and 24 weeks postrandomization. We used mixed-effects models to compare the intervention groups with the control group over time. Significance was set at P < .01. An effect size (ES) of .20 was considered small, .50 moderate and clinically significant, and .80 large.

Results: Compared with the control group, the guided and self-managed iCBT groups reported a significant decrease in the perceived impact of HF/NS (ES, .63 and .56, respectively; both P < .001) and improvement in sleep quality (ES, .57 and .41; both P < .001). The guided group also reported significant improvement in overall levels of menopausal symptoms (ES, .33; P = .003), and NS frequency (ES, .64; P < .001). At longer-term follow-up (24 weeks), the effects remained significant, with a smaller ES for the guided group on perceived impact of HF/NS and sleep quality and for the self-managed group on overall levels of menopausal symptoms. Additional longer-term effects for both intervention groups were found for hot flush frequency.

Conclusion: iCBT, with or without therapist support, has clinically significant, salutary effects on the perceived impact and frequency of HF/NS, overall levels of menopausal symptoms, and sleep quality.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1200/JCO.18.00655DOI Listing
April 2019

Factors associated with an adverse work outcome in breast cancer survivors 5-10 years after diagnosis: a cross-sectional study.

J Cancer Surviv 2019 02 14;13(1):108-116. Epub 2019 Jan 14.

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

Purpose: To identify which factors are associated with adverse work outcome 5-10 years after diagnosis.

Methods: In this cross-sectional study, breast cancer survivors, treated between 2003 and 2008, completed a questionnaire 5-10 years after diagnosis. Adverse work outcome was defined as not having paid employment or working > 20% less compared to prediagnosis. Logistic regression analyses were conducted.

Results: Of 906 participants, 326 (36%) had an adverse work outcome. In multivariable analyses, the probability of an adverse work outcome increased with age (OR, 1.03; 95% CI, 1.00-1.07), time since diagnosis (OR, 1.19; 95% CI, 1.03-1.37), and was higher among women who stated that work had become less important (OR, 2.99; 95% CI, 1.94-4.62). Factors associated with a lower probability of an adverse work outcome were having sufficient financial resources (OR, 0.23; 95% CI, 0.08-0.66), higher total work ability (OR, 0.61; 95% CI, 0.54-0.69), feeling supported at work (OR, 0.52; 95% CI, 0.33-0.80), and, prior to diagnosis, having more children to take care of (OR, 0.65; 95% CI, 0.54-0.79), being able to adjust working hours (OR, 0.55; 95% CI, 0.36-0.83) and not desiring to work less hours if that were to be financially feasible (OR, 1.8; 95% CI, 1.0-3.2).

Conclusions: Predominantly, work-related factors are associated with adverse work outcomes 5-10 years after diagnosis, whereas clinical factors are not. Our results need validation in prospective cohort studies, after which supportive interventions could be developed.

Implications For Cancer Survivors: Work-related factors should be considered in future interventions to prevent adverse work outcome 5-10 years after diagnosis.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s11764-018-0731-7DOI Listing
February 2019

Cancer survivorship: an integral part of Europe's research agenda.

Mol Oncol 2019 03 8;13(3):624-635. Epub 2019 Jan 8.

Huntsman Cancer Institute, Salt Lake City, UT, USA.

Cancer survivorship has traditionally received little prioritisation and attention. For a long time, the treatment of cancer has been the main focus of healthcare providers' efforts. It is time to increase the amount of attention given to patients' long-term well-being and their ability to return to a productive and good life. This article describes the current state of knowledge and identifies research areas in need of development to enable interventions for improved survivorship for all cancer patients in Europe. The article is summed up with 11 points in need of further focus.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/1878-0261.12428DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6396379PMC
March 2019

International phase IV validation study of an EORTC quality of life questionnaire for testicular cancer patients: the EORTC QLQ-TC26.

BMC Cancer 2018 Nov 12;18(1):1104. Epub 2018 Nov 12.

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

Background: Given the high cure-rate for testicular cancer (TC) and the patients' young age, comprehensive evaluation of health-related quality of life (HRQOL) is an important consideration in this patient population. The EORTC QLQ-TC26 questionnaire module has been developed to supplement the EORTC QLQ-C30 in assessing TC-specific HRQOL in clinical trials and routine clinical practice. This international, multicentre phase IV validation study evaluated the psychometric properties of the new module.

Methods: This international, multicentre phase IV validation study enrolled testicular cancer patients from seven European countries. Patients completed the EORTC quality of life core questionnaire EORTC QLQ-C30 and the QLQ-TC26 at two consecutive time points and a debriefing questionnaire regarding the QLQ-TC26 after baseline assessment. Psychometric evaluation included examination of the hypothesized module scale structure, internal consistency and test-retest reliability, known-groups validity, responsiveness to change over time and cross-cultural acceptability.

Results: Data from 313 patients (mean age 38.6, SD 9.5) were analysed. All items exhibited a high completion rate with less than 2.4% missing values except for the sexuality items (up to 8.8%). The confirmatory factor analysis supported the hypothesised scale structure of the QLQ-TC26. Test-retest reliability was good for 8 of 12 scales (intraclass correlation: R t1|t2 ranged from 0.71-0.91) and four scales did not meet the acceptable criteria. Internal consistency was good for all twelve scales (Cronbach alpha = 0.79-0.90), except Communication (alpha = 0.67) and Sexual Functioning (alpha = 0.62). The module was able to distinguish clearly between patients with differing clinical status. Responsiveness to change over time was acceptable.

Conclusion: The EORTC QLQ-TC26 is a valid, reliable and well-accepted condition-specific questionnaire, supplementing the EORTC QLQ-C30, for the assessment of testicular cancer patients' HRQOL in clinical trials.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s12885-018-5036-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6233273PMC
November 2018

Targeting Exercise Interventions to Patients With Cancer in Need: An Individual Patient Data Meta-Analysis.

J Natl Cancer Inst 2018 11;110(11):1190-1200

School of Medicine & Public Health (ELJ) and Priority Research Centre for Physical Activity and Nutrition (RCP), The University of Newcastle, Callaghan, NSW, Australia.

Background: Exercise effects in cancer patients often appear modest, possibly because interventions rarely target patients most in need. This study investigated the moderator effects of baseline values on the exercise outcomes of fatigue, aerobic fitness, muscle strength, quality of life (QoL), and self-reported physical function (PF) in cancer patients during and post-treatment.

Methods: Individual patient data from 34 randomized exercise trials (n = 4519) were pooled. Linear mixed-effect models were used to study moderator effects of baseline values on exercise intervention outcomes and to determine whether these moderator effects differed by intervention timing (during vs post-treatment). All statistical tests were two-sided.

Results: Moderator effects of baseline fatigue and PF were consistent across intervention timing, with greater effects in patients with worse fatigue (Pinteraction = .05) and worse PF (Pinteraction = .003). Moderator effects of baseline aerobic fitness, muscle strength, and QoL differed by intervention timing. During treatment, effects on aerobic fitness were greater for patients with better baseline aerobic fitness (Pinteraction = .002). Post-treatment, effects on upper (Pinteraction < .001) and lower (Pinteraction = .01) body muscle strength and QoL (Pinteraction < .001) were greater in patients with worse baseline values.

Conclusion: Although exercise should be encouraged for most cancer patients during and post-treatments, targeting specific subgroups may be especially beneficial and cost effective. For fatigue and PF, interventions during and post-treatment should target patients with high fatigue and low PF. During treatment, patients experience benefit for muscle strength and QoL regardless of baseline values; however, only patients with low baseline values benefit post-treatment. For aerobic fitness, patients with low baseline values do not appear to benefit from exercise during treatment.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1093/jnci/djy161DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6454466PMC
November 2018

Recall and Retention of Consent Procedure Contents and Decisions: Results of a Randomized Controlled Trial.

Public Health Genomics 2018 10;21(1-2):27-36. Epub 2018 Sep 10.

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

Background: Residual tissue samples, i.e., samples excised for diagnosis or during treatment, are commonly used for medical research. In the Netherlands, they can be used provided the patient did not opt out of this use. Previous research has shown that recall of the informed consent procedure for tissue use is poor. Here, we investigate recall of three consent procedures: informed consent, opt-out, and opt-out plus (an opt-out procedure with an information procedure similar to that of informed consent).

Methods: Patients (n = 1,319) with a variety of diseases were randomized into three trial arms: informed consent, opt-out plus, and opt-out. Questionnaires were administered 6 weeks and 6 months after randomization.

Results: Six hundred and seventy-three and 553 patients returned the 6-week and 6-month questionnaire, respectively. In the informed consent arm, recall of having received a brochure (55.3%) or oral information (69.4%) was similar to that in the opt-out plus arm (48.5 and 71.6%, respectively), at the 6-week assessment. Significantly more respondents in the informed consent and the opt-out plus arms versus the opt-out arm recalled that they had been informed about being able to control tissue use and which consent procedure they had experienced (6-week questionnaire range 53.2-75.8 vs. 13.9-16.1%; 6-month questionnaire range 43.5-84.2 vs. 3.2-35.4%). There were no significant differences between the informed consent and opt-out plus arms in this regard.

Conclusions: Recall of the consent procedure was similar in opt-out plus and informed consent procedures. Overall, recall was moderate, indicating that there is room for improvement in the quality of information provision.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1159/000492662DOI Listing
April 2019

Effects and moderators of exercise on muscle strength, muscle function and aerobic fitness in patients with cancer: a meta-analysis of individual patient data.

Br J Sports Med 2019 Jul 4;53(13):812. Epub 2018 Sep 4.

Center for Quality of Life, Netherlands Cancer Institute, Amsterdam, The Netherlands.

Objective: To optimally target exercise interventions for patients with cancer, it is important to identify which patients benefit from which interventions.

Design: We conducted an individual patient data meta-analysis to investigate demographic, clinical, intervention-related and exercise-related moderators of exercise intervention effects on physical fitness in patients with cancer.

Data Sources: We identified relevant studies via systematic searches in electronic databases (PubMed, Embase, PsycINFO and CINAHL).

Eligibility Criteria: We analysed data from 28 randomised controlled trials investigating the effects of exercise on upper body muscle strength (UBMS) and lower body muscle strength (LBMS), lower body muscle function (LBMF) and aerobic fitness in adult patients with cancer.

Results: Exercise significantly improved UBMS (β=0.20, 95% Confidence Interval (CI) 0.14 to 0.26), LBMS (β=0.29, 95% CI 0.23 to 0.35), LBMF (β=0.16, 95% CI 0.08 to 0.24) and aerobic fitness (β=0.28, 95% CI 0.23 to 0.34), with larger effects for supervised interventions. Exercise effects on UBMS were larger during treatment, when supervised interventions included ≥3 sessions per week, when resistance exercises were included and when session duration was >60 min. Exercise effects on LBMS were larger for patients who were living alone, for supervised interventions including resistance exercise and when session duration was >60 min. Exercise effects on aerobic fitness were larger for younger patients and when supervised interventions included aerobic exercise.

Conclusion: Exercise interventions during and following cancer treatment had small effects on UBMS, LBMS, LBMF and aerobic fitness. Demographic, intervention-related and exercise-related characteristics including age, marital status, intervention timing, delivery mode and frequency and type and time of exercise sessions moderated the exercise effect on UBMS, LBMS and aerobic fitness.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/bjsports-2018-099191DOI Listing
July 2019

Sexual Functioning and Relationship Satisfaction of Partners of Breast Cancer Survivors Who Receive Internet-Based Sex Therapy.

J Sex Marital Ther 2019 22;45(2):91-102. Epub 2018 Nov 22.

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

As part of a larger, randomized controlled trial, we evaluated longitudinally the sexual functioning and relationship satisfaction of 69 partners of breast cancer (BC) survivors who received Internet-based cognitive behavioral therapy (CBT) for sexual dysfunction. The findings suggest that Internet-based CBT positively affects the partners' immediate post-CBT and longer-term overall sexual satisfaction, sexual intimacy, and sexual relationship satisfaction. No sustained changes in other areas of sexual functioning were observed. Our CBT program was focused primarily on the sexual health of the BC survivors. We recommend that future programs include more psychoeducational and behavioral elements targeted at the partners.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1080/0092623X.2018.1488325DOI Listing
December 2019

[The accuracy of patients' perceptions of the risks associated with localised prostate cancer treatments].

Ned Tijdschr Geneeskd 2018 Jun 7;162. Epub 2018 Jun 7.

Universitair Medisch Centrum Utrecht, Cancer Center, afd. Urologie, Utrecht.

Objective: To assess the accuracy of patients' perceptions of the risks associated with localised prostate cancer treatments (radical prostatectomy [RP], radiotherapy [RT], and active surveillance [AS]), and to identify correlates of misperceptions.

Patients And Methods: We used baseline data (questionnaires completed after treatment information was provided but before treatment) of 426 patients with newly diagnosed localised prostate cancer who participated (87% response rate) in a prospective, longitudinal, multicentre study. Patients' pretreatment perceptions of differences in adverse outcomes of treatments were compared to those based on the literature. We used univariate and multivariate linear regression to identify correlates of misperceptions.

Results: About two-thirds (68%, n = 211) of the patients did not understand that the risk of disease recurrence is comparable between RP and RT. More than half of the patients did not comprehend that RP patients are at greater risk of urinary incontinence (65%, n = 202) and erectile dysfunction (61%, n = 190), and less at risk of bowel problems (53%, n = 211) compared to RT patients. Many patients overestimated the risk of requiring definitive treatment following AS (45%, n = 157) and did not understand that mortality rates following AS, RP, and RT are comparable (80%, n = 333). Consulting a radiotherapist or a clinical nurse specialist was positively associated with, and emotional distress was negatively associated with, better understanding of the risks (P < 0.05), although effect sizes were small.

Conclusion: Prior to choosing treatment, most patients with prostate cancer poorly understood the differences in treatment risks. Greater efforts should be made to better understand why these misperceptions occur and, most importantly, how they can be corrected.
View Article and Find Full Text PDF

Download full-text PDF

Source
June 2018

The EORTC CAT Core-The computer adaptive version of the EORTC QLQ-C30 questionnaire.

Eur J Cancer 2018 09 21;100:8-16. Epub 2018 Jun 21.

The Research Unit, Department of Palliative Medicine, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark; Institute of Public Health, University of Copenhagen, Copenhagen, Denmark.

Background: To optimise measurement precision, relevance to patients and flexibility, patient-reported outcome measures (PROMs) should ideally be adapted to the individual patient/study while retaining direct comparability of scores across patients/studies. This is achievable using item banks and computerised adaptive tests (CATs). The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30) is one of the most widely used PROMs in cancer research and clinical practice. Here we provide an overview of the research program to develop CAT versions of the QLQ-C30's 14 functional and symptom domains.

Methods: The EORTC Quality of Life Group's strategy for developing CAT item banks consists of: literature search to identify potential candidate items; formulation of new items compatible with the QLQ-C30 item style; expert evaluations and patient interviews; field-testing and psychometric analyses, including factor analysis, item response theory calibration and simulation of measurement properties. In addition, software for setting up, running and scoring CAT has been developed.

Results: Across eight rounds of data collections, 9782 patients were recruited from 12 countries for the field-testing. The four phases of development resulted in a total of 260 unique items across the 14 domains. Each item bank consists of 7-34 items. Psychometric evaluations indicated higher measurement precision and increased statistical power of the CAT measures compared to the QLQ-C30 scales. Using CAT, sample size requirements may be reduced by approximately 20-35% on average without loss of power.

Conclusions: The EORTC CAT Core represents a more precise, powerful and flexible measurement system than the QLQ-C30. It is currently being validated in a large independent, international sample of cancer patients.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.ejca.2018.04.016DOI Listing
September 2018

Understanding the quality of life (QOL) issues in survivors of cancer: towards the development of an EORTC QOL cancer survivorship questionnaire.

Health Qual Life Outcomes 2018 Jun 4;16(1):114. Epub 2018 Jun 4.

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

Backround: The number of cancer survivors is growing steadily and increasingly, clinical trials are being designed to include long-term follow-up to assess not only survival, but also late effects and health-related quality of life (HRQOL). Therefore it is is essential to develop patient-reported outcome measures (PROMs) that capture the full range of issues relevant to disease-free cancer survivors. The objectives of this project are: 1) to develop a European Organisation for Research and Treatment of Cancer (EORTC) questionnaire that captures the full range of physical, mental and social HRQOL issues relevant to disease-free cancer survivors; and 2) to determine at which minimal time since completion of treatment the questionnaire should be used.

Methods: We reviewed 134 publications on cancer survivorship and interviewed 117 disease-free cancer survivors with 11 different types of cancer across 14 countries in Europe to generate an exhaustive, provisional list of HRQOL issues relevant to cancer survivors. The resulting issue list, the EORTC core questionnaire (QLQ-C30), and site-specific questionnaire modules were completed by a second group of 458 survivors.

Results: We identified 116 generic survivorship issues. These issues covered body image, cognitive functioning, health behaviors, negative and positive outlook, health distress, mental health, fatigue, sleep problems, physical functioning, pain, several physical symptoms, social functioning, and sexual problems. Patients rated most of the acute symptoms of cancer and its treatment (e.g. nausea) as no longer relevant approximately one year after completion of treatment.

Conclusions: Compared to existing cancer survivorship questionnaires, our findings underscore the relevance of assessing issues related to chronic physical side effects of treatment such as neuropathy and joint pain. We will further develop a core survivorship questionnaire and three site-specific modules for disease-free adult cancer survivors who are at least one year post-treatment.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1186/s12955-018-0920-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5987570PMC
June 2018

Psychosocial impact of undergoing prostate cancer screening for men with BRCA1 or BRCA2 mutations.

BJU Int 2019 02 22;123(2):284-292. Epub 2018 Jun 22.

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

Objectives: To report the baseline results of a longitudinal psychosocial study that forms part of the IMPACT study, a multi-national investigation of targeted prostate cancer (PCa) screening among men with a known pathogenic germline mutation in the BRCA1 or BRCA2 genes.

Particpants And Methods: Men enrolled in the IMPACT study were invited to complete a questionnaire at collaborating sites prior to each annual screening visit. The questionnaire included sociodemographic characteristics and the following measures: the Hospital Anxiety and Depression Scale (HADS), Impact of Event Scale (IES), 36-item short-form health survey (SF-36), Memorial Anxiety Scale for Prostate Cancer, Cancer Worry Scale-Revised, risk perception and knowledge. The results of the baseline questionnaire are presented.

Results: A total of 432 men completed questionnaires: 98 and 160 had mutations in BRCA1 and BRCA2 genes, respectively, and 174 were controls (familial mutation negative). Participants' perception of PCa risk was influenced by genetic status. Knowledge levels were high and unrelated to genetic status. Mean scores for the HADS and SF-36 were within reported general population norms and mean IES scores were within normal range. IES mean intrusion and avoidance scores were significantly higher in BRCA1/BRCA2 carriers than in controls and were higher in men with increased PCa risk perception. At the multivariate level, risk perception contributed more significantly to variance in IES scores than genetic status.

Conclusion: This is the first study to report the psychosocial profile of men with BRCA1/BRCA2 mutations undergoing PCa screening. No clinically concerning levels of general or cancer-specific distress or poor quality of life were detected in the cohort as a whole. A small subset of participants reported higher levels of distress, suggesting the need for healthcare professionals offering PCa screening to identify these risk factors and offer additional information and support to men seeking PCa screening.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/bju.14412DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6378691PMC
February 2019

A systematic review of the measurement properties of the European Organisation for Research and Treatment of Cancer In-patient Satisfaction with Care Questionnaire, the EORTC IN-PATSAT32.

Support Care Cancer 2018 Aug 7;26(8):2551-2560. Epub 2018 May 7.

Department of Clinical, Neuro- and Developmental Psychology, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.

Purpose: The EORTC IN-PATSAT32 is a patient-reported outcome measure (PROM) to assess cancer patients' satisfaction with in-patient health care. The aim of this study was to investigate whether the initial good measurement properties of the IN-PATSAT32 are confirmed in new studies.

Methods: Within the scope of a larger systematic review study (Prospero ID 42017057237), a systematic search was performed of Embase, Medline, PsycINFO, and Web of Science for studies that investigated measurement properties of the IN-PATSAT32 up to July 2017. Study quality was assessed, data were extracted, and synthesized according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology.

Results: Nine studies were included in this review. The evidence on reliability and construct validity were rated as sufficient and of the quality of the evidence as moderate. The evidence on structural validity was rated as insufficient and of low quality. The evidence on internal consistency was indeterminate. Measurement error, responsiveness, criterion validity, and cross-cultural validity were not reported in the included studies. Measurement error could be calculated for two studies and was judged indeterminate.

Conclusion: In summary, the IN-PATSAT32 performs as expected with respect to reliability and construct validity. No firm conclusions can be made yet whether the IN-PATSAT32 also performs as well with respect to structural validity and internal consistency. Further research on these measurement properties of the PROM is therefore needed as well as on measurement error, responsiveness, criterion validity, and cross-cultural validity. For future studies, it is recommended to take the COSMIN methodology into account.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s00520-018-4243-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6018571PMC
August 2018

A systematic review of the measurement properties of the Body Image Scale (BIS) in cancer patients.

Support Care Cancer 2018 Jun 12;26(6):1715-1726. Epub 2018 Mar 12.

Department of Clinical, Neuro- and Developmental Psychology, Faculty of Behavioural and Movement Sciences, Amsterdam Public Health Research Institute, Vrije Universiteit Amsterdam, van der Boechorststraat 1, 1081BT, Amsterdam, The Netherlands.

Introduction: Body image is acknowledged as an important aspect of health-related quality of life in cancer patients. The Body Image Scale (BIS) is a patient-reported outcome measure (PROM) to evaluate body image in cancer patients. The aim of this study was to systematically review measurement properties of the BIS among cancer patients.

Methods: A search in Embase, MEDLINE, PsycINFO, and Web of Science was performed to identify studies that investigated measurement properties of the BIS (Prospero ID 42017057237). Study quality was assessed (excellent, good, fair, poor), and data were extracted and analyzed according to the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology on structural validity, internal consistency, reliability, measurement error, hypothesis testing for construct validity, and responsiveness. Evidence was categorized into sufficient, insufficient, inconsistent, or indeterminate.

Results: Nine studies were included. Evidence was sufficient for structural validity (one factor solution), internal consistency (α = 0.86-0.96), and reliability (r > 0.70); indeterminate for measurement error (information on minimal important change lacked) and responsiveness (increasing body image disturbance in only one study); and inconsistent for hypothesis testing (conflicting results). Quality of the evidence was moderate to low. No studies reported on cross-cultural validity.

Conclusion: The BIS is a PROM with good structural validity, internal consistency, and test-retest reliability, but good quality studies on the other measurement properties are needed to optimize evidence. It is recommended to include a wider variety of cancer diagnoses and treatment modalities in these future studies.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s00520-018-4145-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5919987PMC
June 2018

Shared Decision Making in Prostate Cancer Care-Encouraging Every Patient to be Actively Involved in Decision Making or Ensuring the Patient Preferred Level of Involvement?

J Urol 2018 09 6;200(3):582-589. Epub 2018 Mar 6.

Department of Psychosocial Research and Epidemiology, the Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, the Netherlands. Electronic address:

Purpose: The aims of this study were to 1) describe preferred and experienced roles in treatment decision making among patients with localized prostate cancer, 2) identify how often the roles experienced by patients matched their preferred roles and 3) determine whether active involvement in decision making regardless of role preferences or concordance between preferred and experienced roles would be the strongest predictor of more favorable patient reported outcomes.

Materials And Methods: In this prospective, multicenter, observational study we obtained serial questionnaire data from 454 patients with newly diagnosed, localized prostate cancer (cT1-cT2, or Gleason 7 or less and prostate specific antigen 20 ng/ml or less). Questionnaires were completed prior to treatment and at the 3, 6 and 12-month posttreatment followups. Clinical data were obtained from the patient medical records. Active involvement and role concordance were operationalized using the CPS (Control Preferences Scale). ANOVA and effect sizes (small and medium Cohen d = 0.2 and 0.5, respectively) were used to compare patient knowledge of prostate cancer, decision conflict, decision regret and overall health related quality of life.

Results: Of the patients 393 (87%) reported having been actively involved in treatment decision making. However, 78 patients (17%) indicated having had less or more involvement than preferred. Active involvement was significantly associated with more prostate cancer knowledge (d = 0.30), less decision conflict (d = 0.52) and less decision regret (d = 0.34). Role concordance was also but less strongly associated with less decision conflict (d = 0.41).

Conclusions: Our findings support a policy of encouraging all patients with localized prostate cancer regardless of their stated role preferences to be actively involved in the treatment decision.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.juro.2018.02.3091DOI Listing
September 2018

Patients' Attitudes Towards the Return of Incidental Findings After Research with Residual Tissue: A Mixed Methods Study.

Genet Test Mol Biomarkers 2018 Mar 20;22(3):178-186. Epub 2018 Feb 20.

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

Aims: To investigate the attitudes of patients toward the return of individual research results from scientific research with residual tissue.

Methods And Findings: We recruited 1319 patients from 6 Dutch hospitals. In total, 673 patients (51% response rate) completed the questionnaire and 146 were interviewed. Based on the questionnaire data, the majority of respondents (92%) wanted to be informed of incidental findings about both a curable (92%) and an incurable (76%) disease. Respondents' wishes to be informed about incidental findings did not vary significantly as a function of patient demographics or type of disease. The interview data show that respondents wished to be informed about incidental findings because they considered it to be normal practice; they expected the information to be of benefit for their health. Information should be provided by their physician. Yet, most respondents (84%) would consent to research even if they would not be informed about incidental findings, primarily because they recognized that there might be practical problems in providing such information, and because they valued scientific research highly.

Conclusions: We conclude that, while the majority of patients want to be informed about incidental findings, they also recognize that this may be difficult.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1089/gtmb.2017.0222DOI Listing
March 2018

Hyperthermic Intraperitoneal Chemotherapy in Ovarian Cancer.

N Engl J Med 2018 01;378(3):230-240

From the Departments of Gynecology (W.J.D., S.N.K.), Biometrics (K.S., H.T.), Surgical Oncology (A.G.J.A.), Pathology (K.K.V.V.), and Medical Oncology (S.N.K., G.S.S.) and the Division of Psychosocial Research and Epidemiology (J.M.K., N.K.A.), the Netherlands Cancer Institute, Amsterdam, the Center for Gynecologic Oncology Amsterdam, Amsterdam (W.J.D., S.N.K., J.V.), the Dutch Gynecologic Oncology Group (W.J.D., J.H.S.L., H.W.R.S., R.H.M.H., J.V., H.J.A., L.F.A.G.M., G.S.S.), the Department of Obstetrics and Gynecology, Academic Medical Center, Amsterdam (J.V.), the Department of Obstetrics and Gynecology, Sint Antonius Hospital, Nieuwegein (J.H.S.L.), the Department of Gynecologic Oncology, UMC Utrecht Cancer Center, University Medical Center Utrecht, Utrecht (H.W.R.S.), the Departments of Gynecology and Obstetrics (R.H.M.H.) and Surgery (I.H.J.T.H.), Catharina Hospital, Eindhoven, the Dutch Peritoneal Oncology Group (I.H.J.T.H., A.G.J.A.), the Department of Gynecologic Oncology, University of Groningen, University Medical Center Groningen, Groningen (H.J.A.), and the Department of Gynecologic Oncology, Radboud University Medical Center, Nijmegen (L.F.A.G.M.) - all in the Netherlands; and the Department of Surgery, Aarhus University Hospital, Aarhus, Denmark (V.J.V.).

Background: Treatment of newly diagnosed advanced-stage ovarian cancer typically involves cytoreductive surgery and systemic chemotherapy. We conducted a trial to investigate whether the addition of hyperthermic intraperitoneal chemotherapy (HIPEC) to interval cytoreductive surgery would improve outcomes among patients who were receiving neoadjuvant chemotherapy for stage III epithelial ovarian cancer.

Methods: In a multicenter, open-label, phase 3 trial, we randomly assigned 245 patients who had at least stable disease after three cycles of carboplatin (area under the curve of 5 to 6 mg per milliliter per minute) and paclitaxel (175 mg per square meter of body-surface area) to undergo interval cytoreductive surgery either with or without administration of HIPEC with cisplatin (100 mg per square meter). Randomization was performed at the time of surgery in cases in which surgery that would result in no visible disease (complete cytoreduction) or surgery after which one or more residual tumors measuring 10 mm or less in diameter remain (optimal cytoreduction) was deemed to be feasible. Three additional cycles of carboplatin and paclitaxel were administered postoperatively. The primary end point was recurrence-free survival. Overall survival and the side-effect profile were key secondary end points.

Results: In the intention-to-treat analysis, events of disease recurrence or death occurred in 110 of the 123 patients (89%) who underwent cytoreductive surgery without HIPEC (surgery group) and in 99 of the 122 patients (81%) who underwent cytoreductive surgery with HIPEC (surgery-plus-HIPEC group) (hazard ratio for disease recurrence or death, 0.66; 95% confidence interval [CI], 0.50 to 0.87; P=0.003). The median recurrence-free survival was 10.7 months in the surgery group and 14.2 months in the surgery-plus-HIPEC group. At a median follow-up of 4.7 years, 76 patients (62%) in the surgery group and 61 patients (50%) in the surgery-plus-HIPEC group had died (hazard ratio, 0.67; 95% CI, 0.48 to 0.94; P=0.02). The median overall survival was 33.9 months in the surgery group and 45.7 months in the surgery-plus-HIPEC group. The percentage of patients who had adverse events of grade 3 or 4 was similar in the two groups (25% in the surgery group and 27% in the surgery-plus-HIPEC group, P=0.76).

Conclusions: Among patients with stage III epithelial ovarian cancer, the addition of HIPEC to interval cytoreductive surgery resulted in longer recurrence-free survival and overall survival than surgery alone and did not result in higher rates of side effects. (Funded by the Dutch Cancer Society; ClinicalTrials.gov number, NCT00426257 ; EudraCT number, 2006-003466-34 .).
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1056/NEJMoa1708618DOI Listing
January 2018

Internet-Based Cognitive Behavioral Therapy Realizes Long-Term Improvement in the Sexual Functioning and Body Image of Breast Cancer Survivors.

J Sex Marital Ther 2018 15;44(5):485-496. Epub 2018 Feb 15.

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

The study aim was to evaluate the long-term efficacy of Internet-based cognitive behavioral therapy (CBT) for sexual dysfunctions in 84 breast cancer survivors. The positive effects of the intervention on overall sexual functioning, sexual desire, sexual arousal, vaginal lubrication, discomfort during sex, sexual distress, and body image observed immediately posttreatment were maintained at three- and nine-month follow-ups. Although sexual pleasure decreased during follow-up, it did not return to baseline levels. Our findings provide evidence that Internet-based CBT has a sustained, positive effect on sexual functioning and body image of breast cancer survivors with a sexual dysfunction.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1080/0092623X.2017.1408047DOI Listing
March 2019