Health-Related Quality of Life Coupled With Therapeutic Information on Compliance to Endocrine Therapy in Breast Cancer (COMPLIANCE)
Breast Cancer
About this trial
This is an interventional other trial for Breast Cancer focused on measuring Health Related Quality of Life, Compliance, Endocrine Therapy, Therapeutic Information
Eligibility Criteria
Inclusion Criteria:
- Women aged 18 and over
- With non-metastatic hormone receptor positive breast cancer
- Women will have to be at the end of primary treatment
- An indication for endocrine therapy treatment during 5 to 10 years
- be affiliated to a French social security scheme or beneficiary of such a scheme
- agreed to participate by signing a written consent
Exclusion Criteria:
- Participants who participate in another clinical trial where HRQoL is assessed
- Women for whom HRQoL evaluation is not possible (cognitive disorders, psychiatric disorders, people who do not speak French, etc.).
- Vulnerable participants (pregnant women, etc.)
Sites / Locations
- Centre Georges François LeclercRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Interventional arm
Control arm
The intervention will consist in an electronic measurement of HRQoL before each consultation with delivery scores to clinicians, who can discuss it with patients and coupled with therapeutic information. Patients will complete the EORTC-Quality of Life Questionnaire (QLQ)-C30 and the EORTC-QLQ-Breast (BR) 23 questionnaires using the CHES software before their consultation, via a touch pad or from their home via a secure web portal. Therapeutic information will consist on workshops on various themes. Only attendance Workshop 1 will be required, other workshops will be optional. The aim of workshop 1 is to inform patients about their ET and treatment benefits. Two additional optional workshops on nutrition (Workshop 2) and fatigue (Workshop 3) will be offered. This workshops will be collective. Every month, a letter encouraging patients to regularly take their medication will be sent. This letter will also include some tips on how to deal with some particular side effects of ET.
Participants in the control arm will receive standard care. They will not undergo digital HRQoL collection, and therapeutic information workshops will not be proposed.