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

Centre Oscar Lambret

Status: Active, not recruiting

Conditions: Breast Cancer Female

Treatments: Other: Standard supportive approach (Arm B); Other: Personalized Coaching (Arm A)

Study type: Interventional

Funder types: Other

Identifiers

NCT04536584

eMOUVOIR-1901

Details and patient eligibility

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:

• 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.

Enrollment: 1,133 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient ≥18;
• Diagnosis of invasive non-metastatic breast cancer;
• 5 months (+/- 3 months) after the end of the treatment by surgery and/or radiotherapy and/or chemotherapy and/or other "short-term" systemic treatment : immunotherapy, PARP inhibitor, trastuzumab or TDM1 ; the continuation of hormonotherapy (more or less associated with an anti-CDK4/6), trastuzumab or TDM1 is possible during the study period;
• SF-36 filled in completely
• Medical certificate for sports practice delivered by a healthcare professional or oncologist. Neither the previous sports practice, nor the motivation for the proposed program is necessary to participate in the program.
• Agreement for follow-ups during the study period lasting 12 months;
• Ability to understand, read and write French;
• Patient covered by the French "Social Security" regime;
• Signed informed consent for the participation in the study, including the randomization with a 50%/50% chance of being allocated to one or the other group.

Exclusion criteria

• Relapse of invasive breast cancer (loco-regional relapse, contralateral relapse)
• Inability to exercise because of a severe handicap or vulnerability. These contraindications are left to the discretion of the healthcare professional assessing capacity (ex : severe malnutrition, pregnancy ...);
• Metastatic cancer;
• Expressed preference for one arm;
• Inability to comply with follow-up (4 and 12 months) of the trial (geographical, social, medical or psychological reasons);
• Person under guardianship or curatorship.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,133 participants in 2 patient groups

Arm A: personalized coaching for physical activities

Experimental group

Description:

This arm consists of providing patients with a personalized coaching focused on exercise and physical activity, with or without connected watch.

Treatment:

Other: Personalized Coaching (Arm A)

Arm B: standard supportive approach

Active Comparator group

Description:

The standard supportive approach will consist in recommendations made during visits with the oncologist. The delivery of post-treatment care by oncologists and their team systematically provide exercise advice patients including recommendations for strength training and aerobic activity.

Treatment:

Other: Standard supportive approach (Arm B)