"Improving Theempowerment in Patients With Severe Breast Fibrosis Radio-induced Treated by Pravastatin : Benefit of e-PROs (Electronic Patient Reported Outcome ) on Breast-related Quality of Life"

PHASE2RecruitingINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

January 31, 2020

Primary Completion Date

January 31, 2026

Study Completion Date

January 31, 2031

Conditions
Breast Cancer
Interventions
OTHER

e-PRO Intervention

"Statements of symptoms and patients' health status (PROs) will be collected via a web interface, including access and use in patients with burden symptoms.~The platform will include four items concerning 7 side effects of fibrosis of grade \> 2 in breast cancer. Patients will be encouraged to evaluate on a 5-point Likert scale the frequency, the intensity and the repercussions on the daily life of some symptoms during the last 7 days, in particular on:~* general pain~* anxiety~* sadness~* texture of the treated breast~* Patients will also be invited to express themselves on the severity of two other symptoms of their choice, to their worst degree, by listing and rating them on a 5-point scale ranging from None to Very severe Finally, the aesthetic impact will be evaluated by patients on a visual analogue scale (VAS) of 0 to 100mm"

DRUG

Pravastatin

All patients will take Pravastatin 40 mg per day (From Day 0 to Month 12).

Trial Locations (1)

34298

RECRUITING

ICM Val d'Aurelle, Montpellier

All Listed Sponsors
lead

Institut du Cancer de Montpellier - Val d'Aurelle

OTHER