Health-Related Quality of Life Coupled With Therapeutic Information on Compliance to Endocrine Therapy in Breast Cancer — COMPLIANCE  

Breast Cancer Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial Summary

Only 59% of women with breast cancer (BC) treated with Endocrine Therapy (ET) remain compliant one year upon initial prescription, despite its proven effectiveness in reducing recurrence and improving survival. Health-related quality of life (HRQoL) in BC has been widely studied and the positive effects of its routine evaluation on the improvement of communication between patients and medical staff and survival 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. Since compliance is a multidimensional phenomenon, a multifaceted intervention is necessary to improve it. Thus, the investigators hypothesize that systematic HRQoL assessment (using a tablet, prior to each consultation, with delivery of scores to clinicians) coupled with therapeutic information could have an impact on 12-month compliance with ET in patients with non-metastatic BC.

Clinical Trial Description

In this study, 342 women with non-metastatic hormone receptor positive breast cancer with an indication for treatment with endocrine therapy will be include. Participants will be recruited at Dijon cancer center (Georges Francois Leclerc- center) in France. This center is specialized in cancer management, therefore clinicians are experienced in patient's HRQoL evaluation and are accustomed to take this criterion into consideration in the routine patient management. The study will be proposed to eligible participants by their doctors (oncologists, surgeons, radiation oncologists). Participants will be included at the time of the first prescription of ET (at the end of the treatments by surgery +/- chemotherapy +/- radiotherapy). Once included, participants will be randomized (ratio 1:1) by minimization and stratified by: age, stage, type of ET prescribed and presence or not of comorbidities, in 2 arms. Participants will then be referred to the clinical research associates, whose role will be to collect participant data (clinical and sociodemographic) in both study arms and to instruct participants in the interventional arm on how to use the Computer-based Health Evaluation System (CHES) software. For participants who wish to access the platform from home, a login and password will also be provided. If needed, clinical research associates will also assist participants to complete HRQoL questionnaires. This information will be collected in the case report form, to take into account the social desirability bias. The intervention will consist of numerical HRQoL assessment using the CHES software before each consultation (with delivery of scores to clinicians) coupled with therapeutic information. HRQoL assessment will be performed at each visit. As the aim of this project is to integrate this intervention in daily clinical practice, it will be performed in agreement with patients' routine follow-up. Participants will complete the questionnaires prior to each consultation, either at home via access to the web portal within 24 hours before consultation, or at the time of consultation. During consultation physician will have access to the results immediately, via the secure web portal, and will be able to discuss them with the participant. Therapeutic information will consist on 3 workshops. Workshop 1, entitled "Understanding the Prescription" will provide information on ET and its benefits. Two additional optional workshops on nutrition and fatigue will also be offered. Every month, a letter encouraging participants to regularly take their medication will be sent. Participants in the control group will follow standard care. Both in two arms, HRQoL will be evaluated at baseline using the FACT-G questionnaire to ensure the comparability of groups concerning HRQoL at inclusion, and again at 12 months. HRQoL assessment will be performed using a traditional paper questionnaire and scores will not be provided to clinicians. Anxiety and depression, social support and participant satisfaction with care will also be assessed in both arms at baseline and 12 months after. Sociodemographic characteristics, medical and surgical history, date of tumor diagnosis, tumor characteristics, previous treatments, participant clinical characteristics at inclusion and at each follow-up visit (weight, height, overall patient condition), concomitant treatment, type of ET received, HRQoL data (FACT-G), anxiety and depression (HADS), social support (SSQ6), treatment modification (change in the type of ET), treatment-related toxicities and their grade will be collected. Participant satisfaction with provided care will be measured. Clinicians' perceptions of systematic HRQoL assessment will be collected via an ad hoc questionnaire. Sociodemographic data and reasons for refusing to participate will also be documented for patients who refuse to participate. Data on patients' withdrawal or death will be documented in the case report form. Reasons for study withdrawal should also be documented. All data from this study will be transcribed in an electronic case report form. A descriptive analysis of participants' clinical and socio-demographic characteristics at inclusion will be performed for each arm. All HRQoL scores will be calculated according to FACT-G guidelines and described according to the arm (interventional arm or control arm). A logistic regression model will be used to assess the capacity of HRQoL to predict 12-month compliance with endocrine therapy. The modulatory potential of social support on compliance will be assessed using an interaction term between the availability / satisfaction of social support that patients receive and HRQoL in a logistic regression model. The modulatory potential of psychological distress on compliance will be assessed using an interaction term between patient anxiety / depression and HRQoL in a logistic regression model. An analysis of missing HRQoL data profiles will also be performed. If a Missing Not At Random (MNAR) profile is demonstrated / suspected, multiple imputation of missing data can be performed in sensitivity analysis, taking into account the variables associated with the occurrence of missing data. As a sensitivity analysis, the investigators will performed a contamination-based intent-to-treat analysis to account for potential cross-contamination between the arms. ;

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

• NCT number: NCT04176809
• Study type: Interventional
• Source: Centre Georges Francois Leclerc
• Contact: Sandrine DABAKUYO, PhD, HDR
• Phone: 0345348067
• Email: sdabakuyo@cgfl.fr
• Status: Recruiting
• Phase: N/A
• Start date: May 14, 2021
• Completion date: October 2025