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

Trial Title: 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

NCT ID: NCT05677022

Condition: Breast Cancer

Conditions: Official terms:
Breast Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: This is a prospective, longitudinal, single-center, open-label study

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Other
Intervention name: Adapted motor activity
Description: 15-month adapted motor activity program based on a postural and functional analysis
Arm group label: Adapted motor activity

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.

Criteria for 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.

Gender: Female

Gender based: Yes

Gender description: Female breast cancer

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Clairval Hospital Center

Address:
City: Marseille
Zip: 13009
Country: France

Status: Recruiting

Contact:
Last name: Emilie Bialecki, PHD

Phone: 491171428
Email: emilie.bialecki@outlook.fr

Investigator:
Last name: Cyril FOA, MD
Email: Principal Investigator

Start date: February 1, 2023

Completion date: June 1, 2026

Lead sponsor:
Agency: GCS Ramsay Santé pour l'Enseignement et la Recherche
Agency class: Other

Source: GCS Ramsay Santé pour l'Enseignement et la Recherche

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05677022