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

Last Updated: 2024-06-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2026-06-01

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Adapted motor activity

Group Type: EXPERIMENTAL

Adapted motor activity

Intervention Type: OTHER

15-month adapted motor activity program based on a postural and functional analysis

Interventions

Adapted motor activity

15-month adapted motor activity program based on a postural and functional analysis

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GCS Ramsay Santé pour l'Enseignement et la Recherche

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clairval Hospital Center

Marseille, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Cyril FOA, MD

Role: CONTACT

foacyril@club-internet.fr

04 91 17 14 83 ext. 33

Emilie BIALECKI, PHD

Role: CONTACT

emilie.bialecki@outlook.fr

04 91 17 14 28 ext. 33

Facility Contacts

Emilie Bialecki, PHD

Role: primary

emilie.bialecki@outlook.fr

491171428

Other Identifiers

2021-A03091-40

Identifier Type: -

Identifier Source: org_study_id