Clinical trial NCT05677022: 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
Official 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche
Sponsor class: OTHER
First posted: 2023-01-10
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a prospective, longitudinal, single-center, open-label study
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Assessment of compliance
timeFrame: Month 15
Secondary outcomes:
measure: Assessment of the functional impact of the disease
timeFrame: Month 3
measure: Assessment of the functional impact of the disease
timeFrame: Month 9
measure: Assessment of the functional impact of the disease
timeFrame: Month 15
measure: Postural evaluation
timeFrame: Month 3
measure: Postural evaluation
timeFrame: Month 9
measure: Postural evaluation
timeFrame: Month 15
measure: Pain assessment
timeFrame: Month 3
measure: Pain assessment
timeFrame: Month 9
measure: Pain assessment
timeFrame: Month 15
measure: Functional and mobility assessment of the shoulder
timeFrame: Month 3
measure: Functional and mobility assessment of the shoulder
timeFrame: Month 9
measure: Functional and mobility assessment of the shoulder
timeFrame: Month 15
measure: Assessment of the emotional impact of the disease
timeFrame: Month 3
measure: Assessment of the emotional impact of the disease
timeFrame: Month 9
measure: Assessment of the emotional impact of the disease
timeFrame: Month 15
measure: Assessment of the impact of the disease on quality of life
timeFrame: Month 3
measure: Assessment of the impact of the disease on quality of life
timeFrame: Month 3
measure: Assessment of the impact of the disease on quality of life
timeFrame: Month 9
measure: Assessment of the impact of the disease on quality of life
timeFrame: Month 9
measure: Assessment of the impact of the disease on quality of life
timeFrame: Month 15
measure: Assessment of the impact of the disease on quality of life
timeFrame: Month 15
measure: Assessment of sarcopenia
timeFrame: Month 15
measure: Assessment of sarcopenia
timeFrame: Month 15
Other outcomes:
Locations:
city: Marseille
country: France
facility: Clairval Hospital Center
Study officials:
References: