Impact of Personalized and Remote Support Centered on Exercise and Physical Activity for Breast C… (NCT04536584) | Clinical Trial Compass
CompletedNot Applicable
Impact of Personalized and Remote Support Centered on Exercise and Physical Activity for Breast Cancer Patients
France824 participantsStarted 2020-12-18
Plain-language 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.
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 p…