Status
Conditions
Treatments
About
A study that evaluates the benefits of a personalized remote exercise and physical activity coaching compared with the standard supportive approach in terms of health-related quality of life at 12 months in breast cancer survivors treated in an adjuvant setting.
Full description
A multicentric, phase III, randomized open-labelled study with two parallel groups which evaluates the benefits of a personalized remote exercise and physical activity coaching compared with the standard supportive approach in terms of health-related quality of life at 12 months in breast cancer survivors treated in an adjuvant setting.
Other objectives include:
To evaluate the impact of the intervention on each dimension of the SF-36 at 12 months
To evaluate the impact of the program on the health-related quality of life over time
To evaluate the impact of the program on the practice of exercise and physical activity (EPA) at the recommended intensity (30min of moderate EPA, 5 days/week)
To evaluate the impact of the program on:
o fatigue, pain, depression, sleep, motivation for the practice, self-respect, biometric measures (including fat mass and lean mass), physical capacities, patient's satisfaction regarding the assigned program, occurrence of Adverse Events (AE) related to the treatment, professional life for patients who worked before the announcement of getting cancer and psychotropic and analgesic drug intake
To evaluate the compliance to the program through the engagement score during the first 4 months (in the experimental group).
To evaluate the impact of the program in terms of disease-free survival
Additional objectives on health economics include:
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
1,133 participants in 2 patient groups
Loading...
Central trial contact
Marie VANSEYMORTIER
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal