Association between emotional competence and risk of unmet supportive care needs in caregivers of cancer patients at the beginning of care.

PURPOSE: This cross-sectional study explored the associations between intrapersonal and interpersonal emotional competence (EC) and the unmet supportive care needs (SCN), anxiety, and depression of informal caregivers at the beginning of gastrointestinal or haematological cancer care, i.e. during chemotherapy and within 6 months after diagnosis. METHODS: The participants completed a self-reported questionnaire, comprising the Short Profile of Emotional Competence (S-PEC), the SCN survey for partners and caregivers (SCNS-P&C), and the Hospital Anxiety and Depression Scale (HADS). Multivariate logistic regression models were performed to explore the influence of EC on unmet SCN and the presence of moderate/severe anxiety or depression. RESULTS: Most of the 203 caregivers were women (n = 141, 69.80%) and the partners of patients (n = 148, 73.27%) suffering from gastrointestinal (n = 112, 55.17%) and haematological (n = 91, 44.83%) cancer. Only intrapersonal EC showed a significant influence out of all the dimensions of unmet SCN related to healthcare services and information (odds ratio (OR) = 0.35 [95%CI 0.19; 0.65]), emotional and psychological needs (OR = 0.43 [95%CI 0.25; 0.74]), work and social security (OR = 0.57 [95%CI 0.37; 0.88]), and communication and family support (OR = 0.61 [95%CI 0.39; 0.95]). A one-unit increase in the intrapersonal EC score significantly reduced the probability of anxiety (OR = 0.42, [95%CI 0.26; 0.68]) and depression (OR = 0.34, [95%CI 0.21; 0.55]). CONCLUSION: Intrapersonal EC of caregivers is crucial to reduce the risk of unmet SCN, anxiety, and depression from the beginning of care. Identifying caregivers with lower intrapersonal EC may be necessary to increase vigilance from healthcare professionals and psychologists.

Geriatric assessment and quality of life for 2 years in older patients with head and neck cancer.

Due to the location and toxicity of treatments, head and neck cancer (HNC) has a major impact on quality of life (QoL). Objective: to assess the effects of geriatric-assessment (GA)-driven interventions on QoL over 2 years in older adults with HNC.EGeSOR was a randomized study of HNC patients aged ≥65, receiving a pretreatment GA, a geriatric intervention and follow-up (intervention) or standard of care (control). The primary endpoint was QoL score using the European Organisation for Research and Treatment of Cancer's (EORTC QLQ-C30) and HNC (QLQ-HN35) QoL questionnaires over 24 months.In total, 475 patients were included (median age: 75.3; women: 31%; oral cancer: 44%). QoL scores improved over 24 months with various trajectories, without significant differences between the groups. A total of 74% of patients (interventional group) did not receive the complete intervention. Cancer characteristics, functional status, and risk of frailty were associated with change in the Global Health Status QoL score.There is a need to develop an alternative model of implementation such as patient-centered health-care pathways. TRIAL REGISTRATION: NCT02025062.

Financial Toxicity and Health-Related Quality of Life Profile of Patients With Hematologic Malignancies Treated in a Universal Health Care System.

PURPOSE: We investigated the association of financial toxicity (FT) with the health-related quality of life (HRQoL) profile of patients with hematologic malignancies treated in a universal health care system. METHODS: We did a secondary analysis of six multicenter studies enrolling patients with hematologic malignancies. FT was evaluated using the financial difficulties item of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). Multivariable linear regression models were used to assess the mean differences in HRQoL scores between patients with or without FT, while adjusting for key potential confounding factors. We also examined the prevalence of clinically important problems and symptoms by the experience of FT, using established thresholds for the EORTC QLQ-C30. Multivariable binary logistic regression analysis was performed to explore the risk factors associated with FT. RESULTS: Overall, 1,847 patients were analyzed, of whom 441 (23.9%) reported FT. We observed statistically and clinically relevant worse scores for patients with FT compared with those without FT for all the EORTC QLQ-C30 scales. The three largest clinically relevant mean differences between patients with and without FT were observed in pain (∆ = 19.6 [95% CI, 15.7 to 23.5]; P < .001), social functioning (∆ = -18.9 [95% CI, -22.5 to -15.2]; P < .001), and role functioning (Δ = -17.7 [95% CI, -22.1 to -13.3]; P < .001). Patients with FT tended to report a higher prevalence of clinically important problems and symptoms across all EORTC QLQ-C30 scales. In the univariable and multivariable analyses, the presence of FT was associated with the presence of comorbidities, an Eastern Cooperative Oncology Group performance status ≥1, and not receiving a salary. CONCLUSION: Patients with hematologic malignancies treated in the setting of a universal health care system who experience FT have a worse HRQoL profile compared with those without FT.

Opportunities to improve the adoption of health-related quality of life evidence as part of the French Health Technology Assessment process.

OBJECTIVES: Patient's health-related quality of life (HRQoL) is an important outcome measure that is considered by many payers and health technology assessment (HTA) bodies in the evaluation of treatments. We aimed to identify opportunities for HRQoL to be further incorporated into the assessment of the French HTA by comparing three health systems. We put forward recommendations that could bring further innovations to French patients. METHODS: We reviewed methodologies by the French, German and British HTA, and conducted a systematic review of all French (n = 312) and German (n = 175) HTA appraisals from 01 January 2019 to 31 December 2021. We also setup an advisory board of 11 ex-HTA leaders, payers, methodologists, healthcare providers and patient advocates, from France, Britain and Germany, to discuss opportunities to improve acceptance and adoption of HRQoL evidence in France. RESULTS: Our systematic review of HTA appraisals showed a higher HRQoL data rejection rate in France: in > 75% of cases the HRQoL evidence submitted was not accepted for the assessment (usually for methodological reasons, for example, data being considered exploratory; 16-75% of the appraisals mentioned HRQoL evidence, varying by therapeutic area). Overall, we found the French HTA to be more restrictive in its approach than IQWiG. CONCLUSIONS: Based on these findings we articulate collaborative proposals for industry and the HAS to improve acceptance of HRQoL evidence and create a positive feedback loop between HAS and industry along four dimensions (1) patient perception, (2) testing hierarchy, (3) trial design and (4) data collection.

Unmet supportive care needs of caregivers according to medical settings of cancer patients: a cross-sectional study.

PURPOSE: The objectives of this study were to compare the unmet supportive care needs (SCN) of caregivers and describe the 10 most frequent of them according to various cancer settings: phase of cancer care pathway (i.e., treatment vs. follow-up), cancer site (i.e., breast, digestive, or lung cancer), and cancer status (i.e., metastatic vs. non-metastatic). METHODS: Participants completed a self-reported questionnaire to assess their unmet SCN (SCNS-P&C). According to their cancer settings, non-parametric ANOVA or Mann-Whitney tests were performed to compare the SCNS-P&C scores. The prevalence of caregivers with unmet SCN was described using percentages. RESULTS: Among 583 participants, 516 caregivers (88.5%) completed the SCNS-P&C questionnaire. Most patients had digestive (47.3%), non-metastatic cancer (67.6%) and were recruited during the follow-up phase (56.2%). The results revealed no significant difference in SCNS-P&C scores according to cancer settings except for caregivers of patients with metastatic cancer, who reported more unmet SCN related to health care service and information needs. The more qualitative item per item analysis seems to indicate the existence of five frequently unsatisfied SCN across situations, especially concerns about the recurrence and reduction of stress in patients, with variable ranking among the most unmet SCN. CONCLUSION: Although there was no significant difference in unmet SCN scores between medical settings, examining the prevalence of unmet SCN helps identify the issues to focus on when supporting caregivers and developing dedicated consultations or interventions for them.

Palliative care in day-hospital for advanced cancer patients: a study protocol for a multicentre randomized controlled trial.

BACKGROUND: Team-based and timely integrated palliative care is a gold standard of care in oncology, but issues concerning its optimal organization remain. Palliative Care in Day-Hospital (PCDH) could be one of the most efficient service model of palliative care to deliver interdisciplinary and multidimensional care addressing the complex supportive care needs of patients with advanced cancer. We hypothesize that, compared to conventional outpatient palliative care, PCDH allows the clinical benefits of palliative care to be enhanced. METHODS/DESIGN: This study is a multicentre parallel group trial with stratified randomization. Patient management in PCDH will be compared to conventional outpatient palliative care. The inclusion criteria are advanced cancer patients referred to a palliative care team with an estimated life expectancy of more than 2 months and less than 1 year. The primary endpoint is health-related quality of life with deterioration-free survival based on the EORTC QLQ-C30 questionnaire. The secondary objectives are the following: increase in patient satisfaction with care using the EORTC PATSAT-C33 and OUT-PATSAT7 questionnaires, better understanding of the prognosis using the PTPQ questionnaire and advance care planning; decrease in the need for supportive care among relatives using the SCNS-P&C-F questionnaire, and reduction in end-of-life care aggressiveness. Patients will complete one to five questionnaires on a tablet before each monthly visit over 6 months and will be followed for 1 year. A qualitative study will take place, aiming to understand the specificity of palliative care management in PCDH. Cost-effectiveness, cost-utility and, an additional economic evaluation based on capability approach will be conducted from a societal point of view. DISCUSSION: The first strength of this study is that it combines the main relevant outcomes assessing integrated palliative care; patient quality of life and satisfaction; discussion of the prognosis and advance care planning, family well-being and end-of-life care aggressiveness. The second strength of the study is that it is a mixed-method study associating a qualitative analysis of the specificity of PCDH organization, with a medical-economic study to analyse the cost of care. TRIAL REGISTRATION: Name of the registry: IDRCB 2019-A03116-51 Trial registration number: NCT04604873 Date of registration: October 27, 2020 URL of trial registry record.

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

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.

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.

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.

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.

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.

[Adjuvant hormonal therapy for early breast cancer: Assessment of patients' satisfaction]. / Évaluation de la satisfaction de patientes atteintes d'un cancer du sein précoce traitées en adjuvant par hormonothérapie.

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.

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

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.

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.

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.

Psychometric validation of the French version of the Supportive Care Needs Survey for Partners and Caregivers of cancer patients.

The objective of this study was to assess the psychometric properties of the French version of the Supportive Care Needs Survey for Partners and Caregivers (SCNS-P&C-F). The SCNS-P&C-F, the Hospital Anxiety and Depression Scale (HADS) and the CareGiver Oncology Quality of Life questionnaire (CarGOQoL) were completed by 327 caregivers at the baseline. The SCNS-P&C-F was completed a second time by 121 participants within 30 days. Four factors were retained with a good explanation of variance (82.65%) and acceptable internal consistencies (α: 0.70 to 0.94): 1) Health Care Service and Information Needs, 2) Emotional and Psychological Needs, 3) Work and Social Security Needs and 4) Communication and Family Support Needs. Overall, convergent and divergent validities were confirmed. The caregiver's gender, age, professional status and level of anxiety and depression, as well as the type of relationship with the patient and cancer, showed an effect on some caregivers' unmet supportive care needs. Lastly, the test-retest reliability was acceptable (> 0.70), except for the communication and family support dimension. The scale is appropriate for clinical and research use (e.g. good reliability and validity).

Economic Burden of Metastatic Clear-Cell Renal Cell Carcinoma for French Patients Treated With Targeted Therapies.

BACKGROUND: Targeted therapies have transformed the treatment of metastatic clear-cell renal cell carcinoma (mccRCC). Despite the importance of mccRCC, studies on its economic burden in daily practice are sparse. The purpose of this retrospective study was to evaluate cost of illness for 224 patients with mccRCC included in the cohort published by Thiery-Vuillemin et al (Factors influencing overall survival for patients with metastatic clear-cell renal cell-carcinoma in daily practice. Clin Genitourin Cancer 2018; 16:e297-305), and then to determine the explanatory factors of cost of illness. PATIENTS AND METHODS: The study was performed from the French Public Healthcare System perspective with lifetime horizon. Only direct medical costs were included. Multiple linear regression was used to search for explanatory factors of cost of illness. The robustness of results was assessed. RESULTS: The mean cost of illness was estimated at €71,185 ± 52,683. Outpatient/inpatient treatment and hospitalization represented 76.0% and 19.7% of this cost, respectively. After adjustment, 5 explanatory factors were identified: time of disease control for the metastatic first-line treatment ≥6 months, number of lines of treatment >2, nephrectomy at metastatic stage, lack of metastases at presentation, and age at metastatic diagnosis younger than 65 years. Individually, they increased cost of illness by 128%, 95%, 53%, 53%, and 23%, respectively. CONCLUSION: Although it is difficult to transpose our economic evaluation results to those obtained in other countries, it should be noted that our findings were consistent with them and robust. To our knowledge, our study was the first to accurately identify explanatory factors of cost of illness. Identifying them could enable us to predict the budgetary effect on a regional level of managing patients who began their first-line treatment with a targeted therapy.

Development and validation of the FRAGIRE tool for assessment an older person's risk for frailty.

BACKGROUND: Frailty is highly prevalent in elderly people. While significant progress has been made to understand its pathogenesis process, few validated questionnaire exist to assess the multidimensional concept of frailty and to detect people frail or at risk to become frail. The objectives of this study were to construct and validate a new frailty-screening instrument named Frailty Groupe Iso-Ressource Evaluation (FRAGIRE) that accurately predicts the risk for frailty in older adults. METHODS: A prospective multicenter recruitment of the elderly patients was undertaken in France. The subjects were classified into financially-helped group (FH, with financial assistance) and non-financially helped group (NFH, without any financial assistance), considering FH subjects are more frail than the NFH group and thus representing an acceptable surrogate population for frailty. Psychometric properties of the FRAGIRE grid were assessed including discrimination between the FH and NFH groups. Items reduction was made according to statistical analyses and experts' point of view. The association between items response and tests with "help requested status" was assessed in univariate and multivariate unconditional logistic regression analyses and a prognostic score to become frail was finally proposed for each subject. RESULTS: Between May 2013 and July 2013, 385 subjects were included: 338 (88%) in the FH group and 47 (12%) in the NFH group. The initial FRAGIRE grid included 65 items. After conducting the item selection, the final grid of the FRAGIRE was reduced to 19 items. The final grid showed fair discrimination ability to predict frailty (area under the curve (AUC) = 0.85) and good calibration (Hosmer-Lemeshow P-value = 0.580), reflecting a good agreement between the prediction by the final model and actual observation. The Cronbach's alpha for the developed tool scored as high as 0.69 (95% Confidence Interval: 0.64 to 0.74). The final prognostic score was excellent, with an AUC of 0.756. Moreover, it facilitated significant separation of patients into individuals requesting for help from others (P-value < 0.0001), with sensitivity of 81%, specificity of 61%, positive predictive value of 93%, negative predictive value of 34%, and a global predictive value of 78%. CONCLUSIONS: The FRAGIRE seems to have considerable potential as a reliable and effective tool for identifying frail elderly individuals by a public health social worker without medical training.

Evaluation of efficacy and efficiency of a pragmatic intervention by a social worker to support informal caregivers of elderly patients (The ICE Study): study protocol for a randomized controlled trial.

BACKGROUND: Medical progress and the lifestyle modification have prolonged life expectancy, despite the development of chronic diseases. Support and care for older subjects are often provided by a network of informal caregivers composed of family, friends and neighbors, who are essential in helping older persons to continue living at home. It has been shown that the extent and diversity of informal tasks may jeopardize the physical, mental and social wellbeing of caregivers. METHODS/DESIGN: The aim of the Informal Carers of Elderly cohort is to define, through a longitudinal study, profiles of caregivers of older patients with a diagnosis of one of the following diseases: cancer (breast, prostate, colorectal), neurodegenerative diseases (Parkinson's disease, Alzheimer's disease and similar diseases), neurovascular diseases (stroke), sensory diseases (age-related macular degeneration (AMD)) and heart disease (heart failure). Patients must be at least 60 years old and living in the region of Burgundy-Franche-Comte (France). By following the different phases of the caregiving relationship from the announcement of the diagnosis, it will be possible to assess the quality of life of caregivers, coping strategies, levels of anxiety and depression, social support and the extent of their burden. We will also evaluate the efficacy and efficiency of the implementation of a pragmatic intervention by a social worker to help informal caregivers, through a randomized interventional trial nested in the cohort. Qualitative approaches aimed at studying the caregiver/patient relationship, and situations leading to breakdown of the caregiver relationship will be also undertaken. DISCUSSION: Through an analytical and longitudinal definition of profiles of informal caregivers, this study will gather detailed information on their life courses and their health trajectory by identifying consequences associated with the concept of their role as carers. In addition, the randomized interventional trial will explore the relevance of the implementation of a supportive intervention by a social worker to help caregivers. These data will help to identify strategies that could be used to improve the existing sources of aid and to propose new approaches to help caregivers. This study will provide the opportunity to identify the most relevant means of support adapted to caregivers, and provide an impulse for new health care policies. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02626377 . Retrospectively registered on 9 December 2015. Protocol date/version: 23 October 2014/version 2.

Prognostic value of health-related quality of life for death risk stratification in patients with unresectable glioblastoma.

Glioblastoma is the most common malignant brain tumor in adults. Baseline health-related quality of life (HRQoL) is a major subject of concern for these patients. We aimed to assess the independent prognostic value of HRQoL in unresectable glioblastoma (UGB) patients for death risk stratification. One hundred and thirty-four patients with UGB were enrolled from the TEMAVIR trial. HRQoL was evaluated at baseline using the EORTC QLQ-C30 and BN20 brain cancer module. Clinical and HRQoL parameters were evaluated in univariable and multivariable Cox analysis as prognostic factors for overall survival (OS). Performance assessment and internal validation of the final model were evaluated with Harrel's C-index, calibration plot, and bootstrap sample procedure. Two OS independent predictors were identified: future uncertainty and sensitivity deficit. The final model exhibited good calibration and acceptable discrimination (C statistic = 0.63). The internal validity of the model was verified with robust uncertainties around the hazard ratio. The prognostic score identified three groups of patients with distinctly different risk profiles with median OS estimated at 16.2, 9.2, and 4.5 months. We demonstrated the additional prognostic value of HRQoL in UGB for death risk stratification and provided a score that may help to guide clinical management and stratification in future clinical trials.

Time to health-related quality of life score deterioration as a modality of longitudinal analysis for health-related quality of life studies in oncology: do we need RECIST for quality of life to achieve standardization?

PURPOSE: Longitudinal analysis of health-related quality of life (HRQoL) remains unstandardized and compromises comparison of results between trials. In oncology, despite available statistical approaches, results are poorly used to change standards of care, mainly due to lack of standardization and the ability to propose clinical meaningful results. In this context, the time to deterioration (TTD) has been proposed as a modality of longitudinal HRQoL analysis for cancer patients. As for tumor response and progression, we propose to develop RECIST criteria for HRQoL. METHODS: Several definitions of TTD are investigated in this paper. We applied this approach in early breast cancer and metastatic pancreatic cancer with a 5-point minimal clinically important difference. In breast cancer, TTD was defined as compared to the baseline score or to the best previous score. In pancreatic cancer (arm 1: gemcitabine with FOLFIRI.3, arm 2: gemcitabine alone), the time until definitive deterioration (TUDD) was investigated with or without death as event. RESULTS: In the breast cancer study, 381 women were included. The median TTD was influenced by the choice of the reference score. In pancreatic cancer study, 98 patients were enrolled. Patients in Arm 1 presented longer TUDD than those in Arm 2 for most of HRQoL scores. Results of TUDD were slightly different according to the definition of deterioration applied. CONCLUSION: Currently, the international ARCAD group supports the idea of developing RECIST for HRQoL in pancreatic and colorectal cancer with liver metastasis, with a view to using HRQoL as a co-primary endpoint along with a tumor parameter.

A longitudinal analysis of patient satisfaction with care and quality of life in ambulatory oncology based on the OUT-PATSAT35 questionnaire.

BACKGROUND: In the oncology setting, there has been increasing interest in evaluating treatment outcomes in terms of quality of life and patient satisfaction. The aim of our study was to investigate the determinants of patient satisfaction, especially the relationship between quality of life and satisfaction with care and their changes over time, in curative treatment of cancer outpatients. METHODS: Patients undergoing ambulatory chemotherapy or radiotherapy in two centers in France were invited to complete the OUT-PATSAT35, at the beginning of treatment, at the end of treatment, and three months after treatment. This questionnaire evaluates patients' perception of doctors and nurses, as well as other aspects of care organization and services. Additionally, for each patient, socio-demographic and clinical characteristics, and self-reported quality of life data (EORTC QLQ-C30) were collected. RESULTS: Of the 691 patients initially included, 561 answered the assessment at all three time points. By cross-sectional analysis, at the end of the treatment, patients who experienced a deterioration of their global health reported less satisfaction on most scales (p ≤ 0.001). Three months after treatment, the same patients had lower satisfaction scores only in the evaluation of doctors (p ≤ 0.002). Furthermore, longitudinal analysis showed a significant relationship between a deterioration in global health and a decrease in satisfaction with their doctor and, conversely, between an improvement in global health and an increase in satisfaction on the overall satisfaction scale. Global health at baseline was largely and significantly associated with all satisfaction scores measured at the following assessment time points (p < 0.0001). Younger age (<55 years), radiotherapy (versus chemotherapy) and head and neck cancer (versus other localizations) were clinical factors significantly associated with less satisfaction on most scales evaluating doctors. CONCLUSIONS: Pre-treatment self-evaluated global health was found to be the major determinant of patient satisfaction with care. The subsequent deterioration of global health, during and after treatment, emphasized the decrease in satisfaction scores, mainly in the evaluation of doctors. Early initiatives aimed at improving the delivery of care in patients with poor health status should lead to improved perception of the quality of care received.