Evaluation of the Interest of a Postural and Functional Analysis for the Follow-up of the Adapted Motor Activity of Patients Treated for Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- GCS Ramsay Santé pour l'Enseignement et la Recherche
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Assessment of compliance
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
The goal of this clinical trial is to evaluate the acceptability by patients treated for breast cancer of an adapted motor activity program over a period of 15 months controlled by a postural and functional analysis..
Participant population/health conditions: patients with newly operated breast cancer who are candidates for an adapted physical activity program
Detailed Description
This is a prospective, longitudinal, single-center, open-label study of a population of newly operated breast cancer patients who were candidates for an adapted motor activity program. All included patients will be followed for a period of 15 months. Participating physicians will have the opportunity to recruit their patients during the 24 months following the study's initiation. The study will be completed once the last included patient has a final evaluation. The total duration of the study is 39 months (24 months of recruitment and 15 months of follow-up). Each patient will be assessed four times: at inclusion before initiation of cancer treatment, and at M3, M9 and M15. At each patient visit with the investigating physician, an assessment will be completed on the electronic CRF by the physician or by the site CRA under the responsibility of the investigating physician.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Adult woman, having given her consent to participate in the study,
- •Patient with non-metastatic breast cancer,
- •Cancer to be treated by surgery with or without adjuvant treatment (radiotherapy and/or chemotherapy).
Exclusion Criteria
- •Contraindication to the practice of a physical activity,
- •Mental deficiency or any other reason that could hinder the understanding or the strict application of the protocol,
- •Patient not affiliated to the French social security system,
- •Patient under legal protection, guardianship or curatorship,
- •Patient already included in another therapeutic study protocol aimed at evaluating the benefits of adapted physical activity.
Outcomes
Primary Outcomes
Assessment of compliance
Time Frame: Month 15
Patients will be considered compliant if they have attended more than 50% of the physical adaptation program sessions
Secondary Outcomes
- Postural evaluation(Month 15)
- Assessment of the emotional impact of the disease(Month 15)
- Assessment of the impact of the disease on quality of life(Month 15)
- Functional and mobility assessment of the shoulder(Month 15)
- Assessment of sarcopenia(Month 15)
- Assessment of the functional impact of the disease(Month 15)
- Pain assessment(Month 15)