Publications by authors named "Amélie Anota"

63 Publications

An international tool to measure perceived stressors in intensive care units: the PS-ICU scale.

Ann Intensive Care 2021 Apr 10;11(1):57. Epub 2021 Apr 10.

Medical Intensive Care Unit, University Hospital of Besançon, University of Franche-Comte EA 3920, Besançon, France.

Background: The intensive care unit is increasingly recognized as a stressful environment for healthcare professionals. This context has an impact on the health of these professionals but also on the quality of their personal and professional life. However, there is currently no validated scale to measure specific stressors perceived by healthcare professionals in intensive care. The aim of this study was to construct and validate in three languages a perceived stressors scale more specific to intensive care units (ICU).

Results: We conducted a three-phase study between 2016 and 2019: (1) identification of stressors based on the verbatim of 165 nurses and physicians from 4 countries (Canada, France, Italy, and Spain). We identified 99 stressors, including those common to most healthcare professions (called generic), as well as stressors more specific to ICU professionals (called specific); (2) item elaboration and selection by a panel of interdisciplinary experts to build a provisional 99-item version of the scale. This version was pre-tested with 70 professionals in the 4 countries and enabled us to select 50 relevant items; (3) test of the validity of the scale in 497 ICU healthcare professionals. Factor analyses identified six dimensions: lack of fit with families and organizational functioning; patient- and family-related emotional load; complex/at risk situations and skill-related issues; workload and human resource management issues; difficulties related to team working; and suboptimal care situations. Correlations of the PS-ICU scale with a generic stressors measure (i.e., the Job Content Questionnaire) tested its convergent validity, while its correlations with the Maslach Burnout Inventory-HSS examined its concurrent validity. We also assessed the test-retest reliability of PS-ICU with intraclass correlation coefficients.

Conclusions: The perceived stressors in intensive care units (PS-ICU) scale have good psychometric properties in all countries. It includes six broad dimensions covering generic or specific stressors to ICU, and thus, enables the identification of work situations that are likely to generate high levels of stress at the individual and unit levels. For future studies, this tool will enable the implementation of targeted corrective actions on which intervention research can be based. It also enables national and international comparisons of stressors' impact.
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http://dx.doi.org/10.1186/s13613-021-00846-0DOI Listing
April 2021

Patient-Reported Outcomes as Independent Prognostic Factors for Survival in Oncology: Systematic Review and Meta-Analysis.

Value Health 2021 02 6;24(2):250-267. Epub 2021 Jan 6.

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

Objectives: Assessment of patient-reported outcomes (PROs) in oncology is of critical importance because it provides unique information that may also predict clinical outcomes.

Methods: We conducted a systematic review of prognostic factor studies to examine the prognostic value of PROs for survival in cancer. A systematic literature search was performed in PubMed for studies published between 2013 and 2018. We considered any study, regardless of the research design, that included at least 1 PRO domain in the final multivariable prognostic model. The protocol (EPIPHANY) was published and registered in the International Prospective Register of Systematic Reviews (CRD42018099160).

Results: Eligibility criteria selected 138 studies including 158 127 patients, of which 43 studies were randomized, controlled trials. Overall, 120 (87%) studies reported at least 1 PRO to be statistically significantly prognostic for overall survival. Lung (n = 41, 29.7%) and genitourinary (n = 27, 19.6%) cancers were most commonly investigated. The prognostic value of PROs was investigated in secondary data analyses in 101 (73.2%) studies. The EORTC QLQ-C30 questionnaire was the most frequently used measure, and its physical functioning scale (range 0-100) the most frequent independent prognostic PRO, with a pooled hazard ratio estimate of 0.88 per 10-point increase (95% CI 0.84-0.92).

Conclusions: There is convincing evidence that PROs provide independent prognostic information for overall survival across cancer populations and disease stages. Further research is needed to translate current evidence-based data into prognostic tools to aid in clinical decision making.
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http://dx.doi.org/10.1016/j.jval.2020.10.017DOI Listing
February 2021

Feasibility of health-related quality of life (HRQoL) assessment for cancer patients using electronic patient-reported outcome (ePRO) in daily clinical practice.

Qual Life Res 2021 Jan 2. Epub 2021 Jan 2.

Methodological and Quality of Life Unit in Oncology, University Hospital of Besançon, 25000, Besançon, France.

Introduction: Routine Electronic Monitoring of Health-Related Quality of Life (HRQoL) (REMOQOL) in clinical care with real-time feedback to physicians could help to enhance patient-centered care. We evaluated the feasibility of REMOQOL in the French context in the QOLIBRY study. The primary objective was to assess the patients' compliance with REMOQOL.

Methods: The QOLIBRY study was a single-center, prospective study conducted in the University Hospital of Besançon (France). Eligible patients were those treated with systemic therapies for breast, lung or colorectal cancer at any stage. Patients were invited to complete the EORTC QLQ-C30 questionnaire and cancer-site-specific modules before each visit on tablets and/or computers in the hospital or at home. During the consultation, physicians had real-time access to visual summaries of HRQoL scores. Compliance was assessed as adequate if at least 66% of HRQoL assessments were completed during the 4 months of follow-up.

Results: Between March 2016 and October 2018, 177 patients were included in the QOLIBRY study. Median age was 64 years (IQR 54-71). The proportion of patients with an adequate compliance rate was 95.5% (n = 63) in the breast cancer cohort, 98.2% (n = 55) in the colorectal cancer cohort, and 90.9% (n = 50) in the lung cancer cohort. The physicians checked the HRQoL results in 73.1% of visits and prescribed supportive care and adapted patient management in 8.3% and 5.2% of visits, respectively.

Conclusion & Perspectives: The results of QOLIBRY study suggest that REMOQOL is feasible in the French context. However, information about HRQoL monitoring, training of the physicians in the use of the software, and recommendations for using HRQoL results to guide care are essential and must be improved.
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http://dx.doi.org/10.1007/s11136-020-02721-0DOI Listing
January 2021

Nutrition and physical activity: French intergroup clinical practice guidelines for diagnosis, treatment and follow-up (SNFGE, FFCD, GERCOR, UNICANCER, SFCD, SFED, SFRO, ACHBT, AFC, SFP-APA, SFNCM, AFSOS).

BMJ Support Palliat Care 2020 Nov 11. Epub 2020 Nov 11.

Department of Gastroenterology, IBD and Nutrition Support, CHU Beaujon, AP-HP, Paris 7 Diderot University, Clichy La Garenne, France.

This document is a summary of the French intergroup guidelines regarding the nutrition and physical activity (PA) management in digestive oncology. This collaborative work was produced under the auspices of all French medical and surgical societies involved in digestive oncology, nutrition and supportive care. It is based on published guidelines, recent literature review and expert opinions. Recommendations are graded according to the level of evidence. Malnutrition affects more than half of patients with digestive cancers and is often underdiagnosed. It has multiple negative consequences on survival, quality of life and risk of treatment complications. Consequently, in addition to anticancer treatments, supportive care including nutritional support and PA plays a central role in the management of digestive cancers. It is crucial to detect malnutrition (diagnostic criteria updated in 2019) early, to prevent it and to act against it at all stages of the cancer and at all times of the care pathway. In this context, we proposed recommendations for the evaluation and management in nutrition and PA in digestive oncology for each stage of the disease (perioperative setting, during radiation therapy, during systemic treatments, at the palliative phase, after cancer). Guidelines for nutrition and PA management aim at increasing awareness about malnutrition in oncology. They are continuously evolving and need to be regularly updated.
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http://dx.doi.org/10.1136/bmjspcare-2020-002751DOI Listing
November 2020

Feasibility and efficacy of a supervised home-based physical exercise program for metastatic cancer patients receiving oral targeted therapy: study protocol for the phase II/III - UNICANCER SdS 01 QUALIOR trial.

BMC Cancer 2020 Oct 9;20(1):975. Epub 2020 Oct 9.

CHRU de Besançon, Besançon, France.

Background: Currently, oral targeted therapies are known to be effective and are frequently used to treat metastatic cancer patients, but fatigue is a frequently reported early side effect of these treatments. This fatigue may impact the patient's treatment adherence and result in a negative impact on quality of life. Physical exercise significantly improved the general well-being and quality of life of advanced cancer patients. However, there is no specific physical activity program adapted for patients with advanced disease.

Methods: QUALIOR is a two-part, randomized, open-label, and multicenter with two arms phase II/III trial. Patients (phase II: n = 120; phase III: n = 312) with metastatic cancer (breast cancer, kidney cancer, lung cancer, and other cancers [including but not limited to colon cancer, melanoma, sarcoma, or hepatocarcinoma]) treated with a first- or second-line oral targeted therapy without chemotherapy will be included. Patients will be randomized (2:1) to a 3-month supervised home-based standardized physical activity program or to a recommended adapted physical activity (via a booklet). The primary objective of the phase II is to evaluate the feasibility of the supervised program. The primary objective of the phase III is the evaluation of the benefit of the supervised home-based program compare to the recommended program in terms of fatigue and quality of life at 3 months. The secondary objectives aim to evaluate the impact of the supervised program on fatigue over time, pain, physical capacities, psychosocial and cognitive functions, general quality of life, frequency of dose reduction and patients' adherence to the targeted therapy, overall survival, and progression-free survival. This study will also evaluate the medico-economic impact of supervised program compared to the recommended adapted physical activity program.

Discussion: The aim of this study is to evaluate home-based physical exercise program for metastatic cancer patients treated with oral targeted therapies to help patients to cope with fatigue and improve quality of life.

Trial Registration: This trial was registered in ClinicalTrials.gov since May 2017 ( NCT03169075 ).
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http://dx.doi.org/10.1186/s12885-020-07381-4DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7545839PMC
October 2020

Testing two competitive models of empathic communication in cancer care encounters: A factorial analysis of the CARE measure.

Eur J Cancer Care (Engl) 2020 Nov 9;29(6):e13306. Epub 2020 Sep 9.

CNRS, UMR 9193 - SCALab - Sciences Cognitives et Sciences Affectives, Univ. Lille, Lille, France.

Objective: The mechanisms associating physician empathy (PE) with patient outcomes remain unclear. PE can be considered as a whole (one process) or three subcomponents can be identified (an establishing rapport process; an emotional process; a cognitive process). The objective was to test two competitive models of PE in cancer care: a three-process model adapted from Neumann's model versus a one-process model, with the use of the Consultation and Relational Empathy measure (CARE).

Methods: The CARE was completed by 488 oesogastric cancer patients from the national French database FREGAT. A confirmatory factor analysis (CFA) and a bifactor model were performed to test the two competitive models.

Results: The CFA revealed that the one-factor structure showed a moderate fit to the data whereas the three-factor structure showed a good fit. However, the bifactor model favoured unidimensionality.

Conclusion: We cannot provide a clear-cut conclusion about whether PE should be considered as on unique process or not. Further work is still needed. Meanwhile, one should not preclude the use of three subscores in cancer care if specific elements of the encounter need to be assessed.
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http://dx.doi.org/10.1111/ecc.13306DOI Listing
November 2020

Investigating the impact of open label design on patient-reported outcome results in prostate cancer randomized controlled trials.

Cancer Med 2020 10 26;9(20):7363-7374. Epub 2020 Aug 26.

Methodological and Quality of Life Unit in Oncology, University Hospital of Besançon, Besançon, France.

Background: While open-label randomized controlled trials (RCT) are common in oncology, some concerns have been expressed with regard to Patient-Reported Outcomes (PRO)-based claims stemming from these studies. We aimed to investigate the impact of open-label design in the context of prostate cancer (PCa) RCTs with PRO data.

Methods: Randomized controlled trials of PCa with a PRO endpoint published between 2004 and 2018 were considered. RCTs were systematically evaluated on the basis of previously defined criteria, including international PRO reporting quality standards and the Cochrane Collaboration's tool for assessing Risk of Bias. The rate of concordance was estimated and compared between traditional clinical outcomes (eg, survival or tumor response) and PRO in open and blinded RCTs.

Results: We identified 110 RCTs published between 2004 and 2018, of which 62% (n = 68) were open-label. The general characteristics of PCa RCTs were not different according to their design (open-label vs blinded). The proportion of PCa RCTs with high-quality PRO reporting was not different between open-label RCTs and blinded RCTs (41.2% vs 38.1%; P = .75). No statistically significant difference was found between PRO results and concordance with traditional clinical outcomes according to the study design.

Conclusion: Our findings suggest that there is no evidence of significant bias for PROs due to the absence of blinding in the context of PCa RCTs. Further analyses should be conducted in other cancer disease sites.
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http://dx.doi.org/10.1002/cam4.3335DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7571808PMC
October 2020

Longitudinal analysis of health-related quality of life in cancer clinical trials: methods and interpretation of results.

Qual Life Res 2021 Jan 18;30(1):91-103. Epub 2020 Aug 18.

National Platform Quality of Life and Cancer, Montpellier, France.

Purpose: Health-related quality of life (HRQoL) is assessed by self-administered questionnaires throughout the care process. Classically, two longitudinal statistical approaches were mainly used to study HRQoL: linear mixed models (LMM) or time-to-event models for time to deterioration/time until definitive deterioration (TTD/TUDD). Recently, an alternative strategy based on generalized linear mixed models for categorical data has also been proposed: the longitudinal partial credit model (LPCM). The objective of this article is to evaluate these methods and to propose recommendations to standardize longitudinal analysis of HRQoL data in cancer clinical trials.

Methods: The three methods are first described and compared through statistical, methodological, and practical arguments, then applied on real HRQoL data from clinical cancer trials or published prospective databases. In total, seven French studies from a collaborating group were selected with longitudinal collection of QLQ-C30. Longitudinal analyses were performed with the three approaches using SAS, Stata and R software.

Results: We observed concordant results between LMM and LPCM. However, discordant results were observed when we considered the TTD/TUDD approach compared to the two previous methods. According to methodological and practical arguments discussed, the approaches seem to provide additional information and complementary interpretations. LMM and LPCM are the most powerful methods on simulated data, while the TTD/TUDD approach gives more clinically understandable results. Finally, for single-item scales, LPCM is more appropriate.

Conclusion: These results pledge for the recommendation to use of both the LMM and TTD/TUDD longitudinal methods, except for single-item scales, establishing them as the consensual methods for publications reporting HRQoL.
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http://dx.doi.org/10.1007/s11136-020-02605-3DOI Listing
January 2021

Design and methods of a national, multicenter, randomized and controlled trial to assess the efficacy of a physical activity program to improve health-related quality of life and reduce fatigue in women with metastatic breast cancer: ABLE02 trial.

BMC Cancer 2020 Jul 3;20(1):622. Epub 2020 Jul 3.

Department of Cancer and Environment, Léon Bérard Cancer Center, 28 rue Laennec, 69008, Lyon, France.

Background: Patients with a metastatic breast cancer suffer from a deteriorated health-related quality of life and numerous symptoms such as pain, severe fatigue and a decrease of their physical fitness. As the feasibility of a physical activity program has been demonstrated in this population, ABLE02 aims to assess the efficacy of a 6 month-physical activity program using connected devices to improve health-related quality of life and to reduce fatigue in women with metastatic breast cancer.

Methods: ABLE02 is a prospective, national, multicenter, randomized, controlled and open-label study. A total of 244 patients with a metastatic breast cancer, with at least one positive hormone receptor and a first-line chemotherapy planned, will be randomly assigned (1:1 ratio) to: (i) the intervention arm to receive physical activity recommendations, an activity tracker to wear 24 h a day during the whole intervention (6 months) with at least three weekly walking sessions and quizzes each week on physical activity and nutrition (ii) the control arm to receive physical activity recommendations only. Health-related quality of life will be assessed every 6 weeks and main assessments will be conducted at baseline, M3, M6, M12 and M18 to evaluate the clinical, physical, biological and psychological parameters and survival of participants. All questionnaires will be completed on a dedicated application.

Discussion: An activity program based on a smartphone application linked to an activity tracker may help to improve quality of life and reduce fatigue of patients with a metastatic breast cancer. The growth of e-health offers the opportunity to get real-time data as well as improving patient empowerment in order to change long-term behaviors.

Trial Registration: NCT number: NCT04354233 .
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http://dx.doi.org/10.1186/s12885-020-07093-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7333295PMC
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

The Profile of Emotional Competence (PEC): A French short version for cancer patients.

PLoS One 2020 18;15(6):e0232706. Epub 2020 Jun 18.

French National Platform Quality of Life and Cancer, France.

Background: Intrapersonal and interpersonal Emotional Competence (EC) predicts better health and disease adjustment. This study aimed to validate a short version of the Profile of Emotional Competence (PEC) scale for cancer patients.

Methods: Five hundred and thirty-five patients with cancer completed a self-reported questionnaire assessing their intra- and interpersonal EC (PEC), their anxiety and depression symptoms (HADS), and their health-related quality of life (QLQ-C30). Confirmatory factor analyses and Item Response Theory models with the Partial Credit Model were performed to validate and reduce the scale.

Findings: The Short-PEC (13 items), composed of 2 sub-scores of intra- (6 items) and interpersonal (7 items) EC, showed an improved factorial structure (Root Mean Square Error of Approximation (RMSEA) = 0.075 (90% confidence interval 0.066-0.085), comparative fit index = 0.915) with good psychometric properties.

Discussion: Future studies should use the Short-PEC to explain and predict the adjustment of cancer patients. The short-PEC could be also used in clinical routine to assess the level of EC of patients and to adapt psychosocial intervention.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0232706PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7302700PMC
August 2020

Impact of routine assessment of health-related quality of life coupled with therapeutic information on compliance with endocrine therapy in patients with non-metastatic breast cancer: protocol for a randomized controlled trial.

Trials 2020 Jun 16;21(1):527. Epub 2020 Jun 16.

Epidemiology and Quality of Life Research Unit, INSERM U1231, Georges Francois Leclerc Centre - UNICANCER, 1 rue du Professeur Marion, Dijon Cedex, 21000, France.

Background: Despite its proven efficacy in reducing recurrence and improving survival, adherence to endocrine therapy (ET) is suboptimal in women with breast cancer (BC). Health-related quality of life (HRQoL) in BC has been widely studied and many positive effects have been highlighted. Recently, a link between HRQoL and compliance with ET has been suggested, which would suggest a potential role for HRQoL assessment in improving compliance with ET. With the advent of digital technologies, electronic collection of HRQoL on a tablet is now possible. Thus, we hypothesize that systematic HRQoL assessment (using a tablet, prior to each consultation, with presentation of scores to clinicians) coupled with therapeutic information could have an impact on 12-month compliance with ET in patients with non-metastatic BC.

Methods: In this study, we will include 342 women with non-metastatic hormone receptor-positive BC with an indication for treatment with ET. Patients will be randomly assigned 1:1 by minimization and stratified by age, stage, type of ET prescribed, and presence of comorbidities (or not) in two arms. The intervention will consist of numerical HRQoL assessment using the CHES (Computer-based Health Evaluation System) software before each consultation (with delivery of scores to clinicians) coupled with therapeutic information. Therapeutic information will consist of three workshops related to understanding the prescription, nutrition, and fatigue. A reminder letter will be sent to patients every month. Patients in the control group will follow standard care. HRQoL will be assessed using a classic "paper-pencil" collection at baseline in both arms to ensure comparability between arms and at 12 months. The primary endpoint is 12-month compliance with ET. Patient satisfaction with care and the clinicians' perception of the usefulness of routine HRQoL assessment will also be assessed.

Discussion: This study will allow clinicians to identify and better understand the areas in which patients who receive ET have difficulties and thus it will assist clinicians with patient management. Systematic evaluation of HRQoL could provide an additional endpoint for measuring patients' health status and treatment-related symptoms, including ET. If the results of this study are positive, this intervention could be proposed as an integral part of daily clinical practice in patients who receive ET.

Trial Registration: ClinicalTrials.govNCT04176809. Registered Nov. 25, 2019.
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http://dx.doi.org/10.1186/s13063-020-04397-wDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7296931PMC
June 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

Impact on Health-Related Quality of Life of Parenteral Nutrition for Patients with Advanced Cancer Cachexia: Results from a Randomized Controlled Trial.

Oncologist 2020 05 25;25(5):e843-e851. Epub 2020 Mar 25.

INSERM Centre d'Investigation Clinique (CIC) 1431, Centre Hospitalier Universitaire (CHU) Besançon, France.

Background: Malnutrition worsens health-related quality of life (HRQoL) and the prognosis of patients with advanced cancer. This study aimed to assess the clinical benefits of parenteral nutrition (PN) over oral feeding (OF) for patients with advanced cancer cachexia and without intestinal impairment.

Material And Methods: In this prospective multicentric randomized controlled study, patients with advanced cancer and malnutrition were randomly assigned to optimized nutritional care with or without supplemental PN. Zelen's method was used for randomization to facilitate inclusions. Nutritional and performance status and HRQoL using the European Organization for Research and Treatment of Cancer QLQ-C15-PAL questionnaire were evaluated at baseline and monthly until death. Primary endpoint was HRQoL deterioration-free survival (DFS) defined as a definitive deterioration of ≥10 points compared with baseline, or death.

Results: Among the 148 randomized patients, 48 patients were in the experimental arm with PN, 63 patients were in the control arm with OF only, and 37 patients were not included because of early withdrawal or refused consent. In an intent to treat analysis, there was no difference in HRQoL DFS between the PN arm or OF arm for the three targeted dimensions: global health (hazard ratio [HR], 1.31; 95% confidence interval [CI], 0.88-1.94; p = .18), physical functioning (HR, 1.58; 95% CI, 1.06-2.35; p = .024), and fatigue (HR, 1.19; 95% CI, 0.80-1.77; p = .40); there was a negative trend for overall survival among patients in the PN arm. In as treated analysis, serious adverse events (mainly infectious) were more frequent in the PN arm than in the OF arm (p = .01).

Conclusion: PN improved neither HRQoL nor survival and induced more serious adverse events than OF among patients with advanced cancer and malnutrition. Clinical trial identification number. NCT02151214 IMPLICATIONS FOR PRACTICE: This clinical trial showed that parenteral nutrition improved neither quality of life nor survival and generated more serious adverse events than oral feeding only among patients with advanced cancer cachexia and no intestinal impairment. Parenteral nutrition should not be prescribed for patients with advanced cancer, cachexia, and no intestinal failure when life expectancy is shorter than 3 months. Further studies are needed to assess the useful period with a potential benefit of artificial nutrition for patients with advanced cancer.
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http://dx.doi.org/10.1634/theoncologist.2019-0856DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7216468PMC
May 2020

Factors Associated with Health-Related Quality of Life in Women with Breast Cancer in the Middle East: A Systematic Review.

Cancers (Basel) 2020 Mar 16;12(3). Epub 2020 Mar 16.

INSERM (French Institut of Health and Medical Research), EFS BFC (Etablissement français du sang Bourgogne franhce-comté), UMR1098 (Interactions Greffon-Hôte-Tumeur/Ingénierie Cellulaire et Génique), University of Bourgogne Franche-Comté, RIGHT Interactions Greffon-Hôte-Tumeur/Ingénierie Cellulaire et Génique, F-25000 Besançon, France.

Objectives: The aim of the present systematic review was to identify the factors that potentially influence health-related quality of life (HRQoL) in women with breast cancer (BC) in the Middle East.

Methods: A systematic search of the PubMed, Ovid Medline, Cochrane, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Scopus, and Ebscohost databases was conducted to identify all relevant articles published in peer-reviewed journals up to April 2018. The keywords were "Health related quality of life", "Breast Cancer", and "Middle East countries". The Newcastle-Ottawa (NOS) scale was used to evaluate the methodological quality of the included studies. Due to the methodological heterogeneity of the identified studies, no statistical pooling of the individual effect estimates was carried out; instead, the results were summarized descriptively.

Results: A total of 5668 articles were screened and 33 studies were retained. The vast majority of these studies were cross-sectional and only two were longitudinal prospective studies. Concerning the methodological quality, only 39% were of high quality. Our comprehensive literature review identified several modifiable and non-modifiable risk factors associated with HRQoL, including sociodemographic, clinical, and treatment-related factors as well as behavioral and psychosocial factors.

Conclusion: This study has many implications for clinical practice and may provide a framework for establishing policy interventions to improve HRQoL among women with BC. Healthcare systems in the Middle East are encouraged to develop interventional programs targeting modifiable factors, particularly socio-demographic, behavioral, and psychosocial factors.
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http://dx.doi.org/10.3390/cancers12030696DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7140018PMC
March 2020

Inclusion of older patients with cancer in randomised controlled trials with patient-reported outcomes: a systematic review.

BMJ Support Palliat Care 2019 Dec 12;9(4):451-463. Epub 2019 Nov 12.

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

Objectives: Inclusion of patient-reported outcomes (PROs) in cancer randomised controlled trials (RCTs) may be particularly important for older patients. The objectives of this systematic review were to quantify the frequency with which older patients are included in RCTs with PROs and to evaluate the quality of PRO reporting in those trials.

Methods: All RCTs with PRO endpoints, published between January 2004 and February 2019, which included a patient sample with a mean/median age ≥70 years, were considered for this systematic review. The following cancer malignancies were considered: breast, colorectal, lung, prostate, gynaecological and bladder cancer.Quality of PRO reporting was evaluated using the International Society for Quality of Life Research-PRO standards. Studies meeting at least two-thirds of these criteria were considered to have high-quality PRO reporting.

Results: Of 649 RCTs identified with a PRO endpoint, only 72 (11.1%) included older patients. Of these, 35 trials (48.6%) were conducted in patients with metastatic/advanced disease. PROs were primary endpoints in 20 RCTs (27.8%). Overall survival was the most frequently reported clinical outcome in studies of patients with metastatic/advanced cancer (n=28, 80%). One-third of the RCTs (n=24, 33.3%) were considered to have high-quality PRO reporting. Overall, the largest prevalence of RCTs with high-quality PRO reporting was observed in prostate and colorectal cancers.

Conclusions: Our review indicates not only that PRO-RCT-based studies in oncology rarely include older patients but also that completeness of PRO reporting of many of them is often suboptimal.
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http://dx.doi.org/10.1136/bmjspcare-2019-001902DOI Listing
December 2019

[Adjuvant hormonal therapy for early breast cancer: Assessment of patients' satisfaction].

Bull Cancer 2019 Dec 12;106(12):1104-1114. Epub 2019 Oct 12.

CHU de Besançon, pôle pharmaceutique, 3, boulevard Fleming, 25030 Besançon cedex, France; Université Bourgogne Franche-Comté, fédération Hospitalo-Universitaire INCREASE, Interactions Hôte-Greffon-Tumeur/Ingénierie Cellulaire et Génique, EFS BFC, UMR1098, Inserm, 8, rue du Dr Jean-François-Xavier-Girod, 25000 Besançon, France. Electronic address:

Introduction: Since the cancer plan, evaluation of professional practices is essential to ensure the implementation of high-quality health care. Assess patient satisfaction is one of the pillars of high-quality health care. The main objective of the study was to assess the satisfaction of patients with early breast cancer taking a hormonal therapy, the secondary objective was to identify factors associated with their satisfaction.

Methods: The modified EORTC OUT-PATSAT-35 questionnaire was sent to a sample of patients in Franche-Comté in order to evaluate nine dimensions of satisfaction among which interpersonal skills, provided information, and overall satisfaction. For each dimension, a satisfaction score between 0 (no satisfaction) and 100 (highest satisfaction) was measured. Logistic regression analyses were used to study the factors associated with satisfaction.

Results: The mean overall satisfaction score for the 280 patients who answered was 73 [0-100]. Practicing an extra-professional activity was associated with higher satisfaction for several dimensions (odds ratio between 2.80 and 4.12, P<0.05) whereas it was decreased in the case of a modified appetite (odds ratio between 0.27 and 0.52, P<0.05). No link has been shown between satisfaction and adherence.

Discussion: The patients were satisfied and several factors impacting their satisfaction were identified, based on a questionnaire that must evolve to take into account the ambulatory aspect of their care. During the consultations, particular attention will be paid to these factors.
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http://dx.doi.org/10.1016/j.bulcan.2019.08.019DOI Listing
December 2019

Profiles of caregivers most at risk of having unmet supportive care needs: Recommendations for healthcare professionals in oncology.

Eur J Oncol Nurs 2019 Dec 3;43:101669. Epub 2019 Oct 3.

Univ. Lille, UMR CNRS 9193, SCALab, Sciences Cognitives et Sciences Affectives, Rue du Barreau, BP 60149, 59653, Villeneuve d'Ascq cedex, France; French National Platform Quality of Life and Cancer, Besançon, France. Electronic address:

Purpose: This study aimed to identify profiles of caregivers to cancer patients at higher risk of having at least one moderately or highly unmet supportive care need based on 1) relevant socio-demographic (e.g. age, gender) and clinical (e.g. type of cancer, phase of the cancer pathway) variables highlighted in the literature and easily identifiable in routine, and 2) caregivers' anxiety and depression symptoms.

Method: Three hundred and sixty-four main caregivers completed a questionnaire assessing their supportive care needs (SCNS-P&C-F) and anxiety and depression symptoms (HADS) during the treatment or follow-up stage of patients with digestive, breast, or lung cancer. Decision trees were used to identify profiles of caregivers with the Conditional inference Tree (CTree) technique.

Results: In our study, only the combination of three main variables was important to predict the risk of unmet supportive care needs of caregivers: anxiety and/or depression symptoms, the age of caregivers or patients, and the presence/absence of metastases. Emotional distress has the greatest impact, exceeding that of the socio-demographic and clinical variables considered in this study.

Conclusions: This study shows the importance of considering a set of variables and their combinations rather than evaluating their effects separately. Routinely assessing the anxiety and depression symptoms of caregivers using the HADS could improve the screening of caregivers at higher risk of unmet supportive care needs based on socio-demographic and clinical variables only. This study provides recommendations on how to identify caregivers at risk of unmet needs, in the context of an inability to support all caregivers.
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http://dx.doi.org/10.1016/j.ejon.2019.09.010DOI Listing
December 2019

Quality of life with durvalumab in stage III non-small-cell lung cancer.

Lancet Oncol 2019 12 7;20(12):1619-1620. Epub 2019 Oct 7.

Methodology and Quality of Life in Oncology Unit, University Hospital of Besançon, 25 000 Besançon, France; Chest Disease Department, University Hospital of Besançon, 25 000 Besançon, France; INSERM UMR 1098 (Host-Graft-Tumour Interactions and Cell and Tissue Engineering), University of Franche-Comté, Besançon, France.

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http://dx.doi.org/10.1016/S1470-2045(19)30643-6DOI Listing
December 2019

The "Psychosocial Aspects in Hereditary Cancer" questionnaire in women attending breast cancer genetic clinics: Psychometric validation across French-, German- and Spanish-language versions.

Eur J Cancer Care (Engl) 2020 Jan 30;29(1):e13173. Epub 2019 Sep 30.

Institut Curie, Supportive Care Department, Psycho-oncology Unit, Paris and CESP, University Paris-Sud, UVSQ, INSERM, University Paris-Saclay, Villejuif, France.

Background: We performed a comprehensive assessment of the psychometrics of the "Psychosocial Aspects in Hereditary Cancer" (PAHC) questionnaire in French, German and Spanish.

Methods: Women consecutively approached in Cancer Genetic Clinics completed the PAHC, distress and satisfaction questionnaires at pre-testing (T1) and after test result disclosure (T2). In addition to standard psychometric attributes, we assessed the PAHC ability to respond to change (i.e. improvement or deterioration from T1 to T2) in perceived difficulties and computed minimal important differences (MID) in PAHC scores as compared with self-reported needs for additional counselling.

Results: Of 738 eligible counselees, 214 (90%) in France (Paris), 301 (92%) in Germany (Cologne) and 133 (77%) in Spain (Barcelona) completed the PAHC. A six-factor revised PAHC model yielded acceptable CFA goodness-of-fit indexes and good all scales internal consistencies. PAHC scales demonstrated expected conceptual differences with distress and satisfaction with counselling. Different levels of psychosocial difficulties were evidenced between counselees' subgroups and over time (p-values < .05). MID estimates ranged from 8 to 15 for improvement and 9 to 21 for deterioration.

Conclusion: The PAHC French, German and Spanish versions are reliable and valid for evaluating the psychosocial difficulties of women at high BC risk attending genetic clinics.
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http://dx.doi.org/10.1111/ecc.13173DOI Listing
January 2020

Psychosocial problems in women attending French, German and Spanish genetics clinics before and after targeted or multigene testing results: an observational prospective study.

BMJ Open 2019 09 24;9(9):e029926. Epub 2019 Sep 24.

Department of Supportive Care, Psycho-Oncology Unit, Institut Curie, Paris, France.

Objectives And Setting: Advances in multigene panel testing for cancer susceptibility has increased the complexity of counselling, requiring particular attention to counselees' psychosocial needs. Changes in psychosocial problems before and after genetic testing were prospectively compared between genetic test results in women tested for breast or ovarian cancer genetic susceptibility in French, German and Spanish clinics.

Participants And Measures: Among 752 counselees consecutively approached, 646 (86%) were assessed after the initial genetic consultation (T1), including 510 (68%) affected with breast cancer, of which 460 (61%) were assessed again after receiving the test result (T2), using questionnaires addressing genetic-specific psychosocial problems (Psychosocial Aspects of Hereditary Cancer (PAHC)-six scales). Sociodemographic and clinical data were also collected.

Results: Seventy-nine (17.2%), 19 (4.1%), 259 (56.3%), 44 (9.6%) and 59 (12.8%) women received a , another high/moderate-risk pathogenic variant (PV), negative uninformative, true negative (TN) or variant of uncertain significance result (VUS), respectively. On multiple regression analyses, compared with women receiving another result, those with a VUS decreased more in psychosocial problems related to hereditary predisposition (eg, ) (ß=-0.11, p<0.05) and familial/social issues (eg, ) (ß=-0.13, p<0.05), almost independently from their problems before testing. Women with a PV presented no change in hereditary predisposition problems and, so as women with a TN result, a non-significant increase in familial/social issues. Other PAHC scales (ie, emotions, familial cancer, personal cancer and children-related issues) were not affected by genetic testing.

Conclusions: In women tested for breast or ovarian cancer genetic risk in European genetics clinics, psychosocial problems were mostly unaffected by genetic testing. Apart from women receiving a VUS result, those with another test result presented unchanged needs in counselling in particular about hereditary predisposition and familial/social issues.
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http://dx.doi.org/10.1136/bmjopen-2019-029926DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6773290PMC
September 2019

Impact on health-related quality of life deterioration-free survival of a first-line therapy combining nab-paclitaxel plus either gemcitabine or simplified leucovorin and fluorouracil for patients with metastatic pancreatic cancer: Results of the randomized phase II AFUGEM GERCOR clinical trial.

Cancer Med 2019 Sep 17;8(11):5079-5088. Epub 2019 Jul 17.

Methodology and Quality of Life Unit in Oncology, INSERM UMR 1098, University Hospital of Besançon, Besançon, France.

Background: The phase II AFUGEM GERCOR trial aimed to assess the efficacy of a first-line therapy combining nab-paclitaxel plus either gemcitabine (gemcitabine group) or simplified leucovorin and fluorouracil (sLV5FU2 group) in patients with previously untreated metastatic pancreatic cancer. Results of progression-free survival at 4 months (primary endpoint) were in favor of the sLV5FU2 group. This paper presents health-related quality of life (HRQoL) data as a secondary endpoint.

Methods: HRQoL was assessed using the EORTC QLQ-C30 questionnaire at baseline and at each chemotherapy cycle until the end of treatment. The HRQoL deterioration-free survival (QFS) was used as a modality of longitudinal analysis. QFS was defined as the time between randomization and the first definitive HRQoL score deterioration as compared to the baseline score, or death. Sensitivity analysis was performed excluding death as an event. Univariate Cox models were used to estimate hazard ratios (HRs) and 90% confidence intervals (CIs) of the treatment effect.

Results: Between 2013 and 2014, 114 patients were randomized in a 1:2 ratio (39 in the gemcitabine group and 75 in the sLV5FU2 group). Patients in the sLV5FU2 group seemed to present longer QFS than those of the gemcitabine group for 14 out of 15 dimensions, with HRs < 1. Results of the sensitivity analysis excluding death as an event were significantly in favor of the sLV5FU2 group for physical functioning (HR = 0.51 [90% CI 0.27-0.97]) and pain (HR = 0.26 [90% CI 0.09-0.74]).

Conclusion: The nab-paclitaxel plus simplified leucovorin and fluorouracil combination had no negative impact in exploratory HRQoL analyses.
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http://dx.doi.org/10.1002/cam4.2311DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6718524PMC
September 2019

Health-Related Quality of Life Impact from Adding Bevacizumab to Cisplatin-Pemetrexed in Malignant Pleural Mesothelioma in the MAPS IFCT-GFPC-0701 Phase III Trial.

Clin Cancer Res 2019 10 7;25(19):5759-5765. Epub 2019 Jun 7.

Department of Thoracic Oncology, Centre d'investigation clinique Institut national de la santé et de la recherche médicale 1425, Hospital Bichat-Claude Bernard, Assistance Publique-Hôpitaux de Paris, Paris-Diderot University (Paris 7), Paris, France.

Purpose: The IFCT-GFPC-0701 MAPS phase III trial highlighted significant improvement in overall survival from adding bevacizumab to the standard first-line chemotherapy regimen [cisplatin plus pemetrexed (PC)] in advanced malignant pleural mesothelioma (MPM). We present the results of health-related quality of life (HRQoL), a secondary endpoint of MAPS.

Patients And Methods: HRQoL was assessed using the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire QLQ-C30 and the lung cancer-specific module QLQ-LC13 at randomization and then every 9 weeks until disease progression.HRQoL deterioration-free survival (QFS), used to analyze longitudinal HRQoL data, was defined as the interval between randomization and the occurrence of the first clinically relevant definitive deterioration compared with the HRQoL score at baseline, or death.

Results: A total of 448 patients were included in the MAPS trial between 2008 and 2014. At baseline, 425 patients (94.8%) completed the HRQoL questionnaire. We report that adding bevacizumab to cisplatin and pemetrexed (PCB) significantly improved QFS for the peripheral neuropathy dimension, with a median QFS of 12.09 months [95% confidence interval (CI), 9.59-13.67] in the PCB arm versus 7.59 months (95% CI, 6.57-8.61) in the PC arm [HR (PCB vs. PC) = 0.74; 95% CI, 0.61-0.91; = 0.004]. QFS was also longer in the PCB arm for the pain dimension (HR = 0.84; 95% CI, 0.69-1.02; = 0.08).

Conclusions: This study demonstrated that adding bevacizumab to standard chemotherapy in patients with advanced MPM had no negative impact on HRQoL. A significant improvement in the peripheral neuropathy and pain HRQoL dimensions was even observed.
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http://dx.doi.org/10.1158/1078-0432.CCR-18-2860DOI Listing
October 2019

Health-related quality of life as an endpoint in oncology phase I trials: a systematic review.

BMC Cancer 2019 Apr 16;19(1):361. Epub 2019 Apr 16.

Methodology and Quality of Life in Oncology Unit, INSERM UMR 1098, University Hospital of Besançon, Besançon, France.

Background: Phase I trials aim to identify the recommended dose for further development. Health-related quality of life (HRQoL) could be a complement to the usual National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) scale to detect adverse events and define the doses. The objective of this study is to review the phase I in oncology which used HRQoL as endpoint.

Methods: A search in PubMed database identified phase I trials in oncology with HRQoL as endpoint, published between January 2012 to May 2016. Hematological and pediatric phase I were excluded.

Results: A total of 1333 phase I were identified and 15 trials were identified with HRQoL as endpoint (1.1%). The European Organisation for Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) was the most frequently used instrument: 5 studies (33.3%). The targeted dimensions of HRQoL and the minimal clinically important difference were prespecified in 1 study (6.7%) and 2 studies (13.3%), respectively. Twelve studies (80%) described the statistical approach to analyze HRQoL data. Eight studies used the mean change from baseline (60%) to analyse longitudinal HRQoL data, two the mean score at certain times (13.3%), one the linear mixed model for repeated measures (6.7%), one the time to HRQoL score deterioration (6.7%), one percentage of patient-reported symptoms (6.7%). None of the studies used HRQoL to determine the recommended doses.

Conclusion: Few phase I studies used HRQoL as endpoint and among studies with HRQoL as endpoint, the methodology of HRQoL measurement and statistical analysis was heterogeneous. HRQoL. endpoint not used for assessing the recommended phase II doses.
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http://dx.doi.org/10.1186/s12885-019-5579-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6469065PMC
April 2019

SENTICOL III: an international validation study of sentinel node biopsy in early cervical cancer. A GINECO, ENGOT, GCIG and multicenter study.

Int J Gynecol Cancer 2019 05 20;29(4):829-834. Epub 2019 Mar 20.

Gynecologic Oncology, CCTG, Fondation du CHU de Quebec, Quebec City, Quebec, Canada.

Background: Radical hysterectomy and complete pelvic lymphadenectomies are the most commonly performed procedures for women with early-stage cervical cancer. Sentinel lymph node (SLN) mapping could be an alternative to routine pelvic lymphadenectomy, aiming to diagnose accurately nodal extension and decrease lymphatic morbidity.

Primary Objective: To compare 3-year disease-free survival and health-related quality of life after SLN biopsy or SLN biopsy + pelvic lymphadenectomy in early cervical cancer.

Study Hypothesis: We hypothesize that disease-free survival is non-inferior and health-related quality of life superior after SLN biopsy compared with SLN biopsy + pelvic lymphadenectomy.

Trial Design: International, randomized, multicenter, single-blind trial. The study will be run by teams trained to carry out SLN biopsy, belonging to clinical research cooperative groups or recognized as experts in this field. Patients with an optimal mapping (Memorial Sloan Kettering Cancer Center [MSKCC] criteria) and a negative frozen section will be randomized 1:1 to SLN biopsy only or SLN biopsy + pelvic lymphadenectomy.

Inclusion, Exclusion Criteria: Patients with early stages (Ia1 with lymphovascular invasion to IIa1) of disease. Histological types are limited to squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma.

Primary Endpoint: Main endpoint will be co-primary endpoint, associating 3-year disease-free survival and quality of life (QLQ-C30 and QLQ-CX24).

Sample Size: 950 patients need to be randomized.Estimated dates for completing accrual and presenting results: study started on Q2 2018, last accrual is scheduled for Q2 2021, and last follow-up in Q2 2026.

Trial Registration: ClinicalTrials.gov identifier: NCT03386734.
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http://dx.doi.org/10.1136/ijgc-2019-000332DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7445752PMC
May 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.
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http://dx.doi.org/10.2217/cer-2018-0092DOI Listing
April 2019

Propensity score methods and regression adjustment for analysis of nonrandomized studies with health-related quality of life outcomes.

Pharmacoepidemiol Drug Saf 2019 05 19;28(5):690-699. Epub 2019 Feb 19.

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

Purpose: The aim of this study was to investigate the potential added value of combining propensity score (PS) methods with multivariable linear regression (MLR) in estimating the average treatment effect on the treated (ATT) in nonrandomized studies with health-related quality of life (HRQoL) outcomes.

Methods: We first used simulations to compare the performances of different PS-based methods, either alone or in combination with further MLR adjustment, in estimating ATT. PS methods were, respectively, optimal pair (OPM) and full (OFM) PS matching, subclassification on the PS (SBC), and the inverse probability of treatment weighting (IPTW). We simulated several scenarios, according to different sample sizes, proportions of treated vs untreated subjects, and types of HRQoL outcomes. We also applied the same methods to a real clinical data set.

Results: OPM and IPTW provided the closest Type I error to the nominal threshold α = 0.05 across all scenarios. Overall, both methods showed also lower variability in estimates than SBC and OFM. SBC performed worst, generally providing the highest levels of bias. Further MLR adjustment lessened bias for all methods, however providing higher Type I error for SBC and OFM. In the real case, all methods provided similar ATT estimates except for one outcome.

Conclusions: Our findings suggest that for sample sizes up to n = 200, OPM and IPTW are to be preferred to OFM and SBC in estimating ATT on HRQoL outcomes. Specifically, OPM performed best in sample sizes of n ≥ 80, IPTW for smaller sample sizes. Additional MLR adjustment can further improve ATT estimates.
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http://dx.doi.org/10.1002/pds.4756DOI Listing
May 2019

The role of trait emotional intelligence in quality of life, anxiety and depression symptoms after surgery for esophageal or gastric cancer: A French national database FREGAT.

Psychooncology 2019 04 27;28(4):799-806. Epub 2019 Feb 27.

Affective and Cognitive Sciences, University Lille, UMR CNRS 9193-SCALab, Villeneuve d'Ascq Cedex, France.

Objective: The main objective was to test the indirect effects of emotional competence (EC) after diagnosis (T1) on the health-related quality of life (HRQoL) after surgery (T2) of esogastric cancer patients via fewer anxiety and depression symptoms (T2).

Methods: Data were collected from 30 French centers via the clinicobiological database French EsoGastric Tumors (FREGAT). Two hundred and twenty-eight participants completed a self-reported questionnaire at T1 and T2, assessing their EC (Profile of Emotional Competence (PEC)), HRQoL (EORTC Quality of Life Questionnaire-Core (QLQ-C30)), and anxiety and depression symptoms (Hospital Anxiety and Depression Scale (HADS)). Regression analyses were used to test the direct effects of intrapersonal and interpersonal EC on their anxiety/depression symptoms and HRQoL at T1 and T2. The PROCESS Macro in SPPS v.22 with bootstrap methods was used to test the indirect effects of intrapersonal and interpersonal EC at T1 on HRQoL at T2 via anxiety and depression symptoms.

Results: EC predicted fewer anxiety and depression symptoms of patients at T1 and T2 and better HRQoL at T1. EC at T1 also predicted a better HRQoL at T2 via fewer anxiety and depression symptoms at T2.

Conclusions: Patients who tended to use their EC in daily life could be more effective in regulating the emotional impact of the cancer diagnosis and surgery. This explains why they reported fewer anxiety and depression symptoms, which in turn enabled a better perceived HRQoL after surgery. Therefore, reinforcing the use of patients' EC in daily life following their diagnosis could decrease their emotional distress and, in this way, improve their HRQoL in the preoperative and postoperative stages.
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http://dx.doi.org/10.1002/pon.5023DOI Listing
April 2019

Health-related quality of life assessment for patients with advanced or metastatic renal cell carcinoma treated with a tyrosine kinase inhibitor using electronic patient-reported outcomes in daily clinical practice (QUANARIE trial): study protocol.

Health Qual Life Outcomes 2019 Feb 4;17(1):25. Epub 2019 Feb 4.

Department of Medical Oncology, University Hospital of Besançon, Boulevard Fleming, F-25000, Besançon, France.

Background: Two main therapies, pazopanib and sunitinib, are used in the first-line setting for metastatic renal cell carcinoma (mRCC). These two tyrosine kinase inhibitors (TKI) are equally effective in terms of survival; however, they frequently induce adverse events. In this setting, Health-Related Quality of life (HRQoL) is a key element in the choice between these two treatments and the evaluation of treatment effectiveness. It could be of interest to evaluate HRQoL in daily clinical practice to aid adequate therapy choice and management. Currently, the development of information and communication technology may allow HRQoL monitoring in routine practice. The objective of the QUANARIE study is to evaluate the use of HRQoL assessment in daily clinical practice for patients with mRCC treated with TKI using electronic patient-reported outcomes (e-PRO). The present article describes the key elements of the study protocol.

Methods: The QUANARIE study is an interventional, prospective, multicentre trial. Patients diagnosed with mRCC initiating sunitinib or pazopanib treatment will be invited to complete the EORTC QLQ-C30 questionnaire, nine additional questions from the EORTC items library, and the EuroQoL EQ-5D, prior to each visit with the physician. Questionnaires will be completed by patients using tablets and/or computer terminals via the e-PRO software. The physician will have real-time access to a visual summary of the HRQoL evaluation. The primary objective is to assess the proportion of patients having good compliance with Routine Electronic Monitoring of HRQoL (REMOQOL) during the first 12 months. Physicians' satisfaction with REMOQOL will be assessed as a secondary objective. We hypothesise that 80% of patients having good compliance with REMOQOL would be meaningful. A sample size of 56 patients would be needed.

Discussion: The results of this study will show whether REMOQOL is feasible on a large scale and whether patients are receptive to this new practice. This study will also determine how real-time multidimensional evaluation of patient perception can help physicians in their daily practice and how they used it in conjunction with other clinical information to manage patient care.

Trial Registration: ClinicalTrials.gov; Identifier: NCT03062410 ; First Posted: February 23, 2017; Last Update Posted: August 9, 2017.
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http://dx.doi.org/10.1186/s12955-019-1085-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6360763PMC
February 2019

Modeling strategies to improve parameter estimates in prognostic factors analyses with patient-reported outcomes in oncology.

Qual Life Res 2019 May 18;28(5):1315-1325. Epub 2019 Jan 18.

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

Purpose: The inclusion of patient-reported outcome (PRO) questionnaires in prognostic factor analyses in oncology has substantially increased in recent years. We performed a simulation study to compare the performances of four different modeling strategies in estimating the prognostic impact of multiple collinear scales from PRO questionnaires.

Methods: We generated multiple scenarios describing survival data with different sample sizes, event rates and degrees of multicollinearity among five PRO scales. We used the Cox proportional hazards (PH) model to estimate the hazard ratios (HR) using automatic selection procedures, which were based on either the likelihood ratio-test (Cox-PV) or the Akaike Information Criterion (Cox-AIC). We also used Cox PH models which included all variables and were either penalized using the Ridge regression (Cox-R) or were estimated as usual (Cox-Full). For each scenario, we simulated 1000 independent datasets and compared the average outcomes of all methods.

Results: The Cox-R showed similar or better performances with respect to the other methods, particularly in scenarios with medium-high multicollinearity (ρ = 0.4 to ρ = 0.8) and small sample sizes (n = 100). Overall, the Cox-PV and Cox-AIC performed worse, for example they did not select one or more prognostic collinear PRO scales in some scenarios. Compared with the Cox-Full, the Cox-R provided HR estimates with similar bias patterns but smaller root-mean-squared errors, particularly in higher multicollinearity scenarios.

Conclusions: Our findings suggest that the Cox-R is the best approach when performing prognostic factor analyses with multiple and collinear PRO scales, particularly in situations of high multicollinearity, small sample sizes and low event rates.
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http://dx.doi.org/10.1007/s11136-018-02097-2DOI Listing
May 2019