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

  • STATUS
    Recruiting
  • End date
    Apr 25, 2023
  • participants needed
    1380
  • sponsor
    Centre Oscar Lambret
Updated on 25 April 2021

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.

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:
    • 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.

Details
Condition Breast Cancer Female
Treatment Personalized Coaching (Arm A), Standard supportive approach (Arm B)
Clinical Study IdentifierNCT04536584
SponsorCentre Oscar Lambret
Last Modified on25 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patient 18
Diagnosis of breast cancer in an adjuvant or neoadjuvant setting
In post-cancer period, between 4 and 6 months after the end of the treatment by surgery and/or radiotherapy and/or chemotherapy; the continuation of hormonotherapy and trastuzumab is possible during the study period
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

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 (12 months) of the trial (geographical, social, medical or psychological reasons)
Person under guardianship or curatorship
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