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

NCT05677022 | Recruiting

• 1 other identifier: 2021-A03091-40
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Assessment of compliance

  Patients will be considered compliant if they have attended more than 50% of the physical adaptation program sessions

  Month 15

Secondary Outcomes (23)

• Assessment of the functional impact of the disease

  Month 3

• Assessment of the functional impact of the disease

  Month 9

• Assessment of the functional impact of the disease

  Month 15

• Postural evaluation

  Month 3

• Postural evaluation

  Month 9

Study Arms (1)

Adapted motor activity

EXPERIMENTAL

Other: Adapted motor activity

Interventions

Adapted motor activity OTHER

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

Adapted motor activity

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Female breast cancer
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• GCS Ramsay Santé pour l'Enseignement et la Recherche: lead

Study Sites (1)

Clairval Hospital Center

Marseille, 13009, France

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Cyril FOA, MD

CONTACT

04 91 17 14 83; foacyril@club-internet.fr

Emilie BIALECKI, PHD

CONTACT

04 91 17 14 28; emilie.bialecki@outlook.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a prospective, longitudinal, single-center, open-label study

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 10, 2023
• Study Start: February 1, 2023
• Primary Completion: February 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: June 28, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)