NCT04536584

Impact of Personalized and Remote Support Centered on Exercise and Physical Activity for Breast Cancer Patients

Randomized Study Estimating the Impact of a Personalized and Remote Support Centered on Exercise and Physical Activity for Patients After Breast Cancer

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 824 (actual)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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: * To evaluate the efficiency of the personalized remote exercise and physical activity coaching compared with the standard supportive approach in BC survivors treated in an adjuvant setting. * To characterize the health-state utility of BC survivors over time; assessing the association of change in health-utility with changes in other variables such as exercise and physical activity.

Conditions

• Breast Cancer Female

Interventions

Type	Name	Description
OTHER	Personalized Coaching (Arm A)	Patients will receive personalized physical activity coaching with an online digital platform to take online educational workshops and interact with other peers of the cohort with a online private forum. They will also have a connected watch that will measure several physical activity metrics.
OTHER	Standard supportive approach (Arm B)	Patients will receive the standard recommendations during their visits with the oncologist. The exercise recommendations include strength training and aerobic activities.

Timeline

• Start date: 2020-12-18
• Primary completion: 2024-06-26
• Completion: 2024-06-26
• First posted: 2020-09-02
• Last updated: 2026-03-18

Locations

22 sites across 1 country: France