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Recruiting Not applicable

Health Economic Evaluation of an Adapted Physical Activity Program for Women With Breast Cancer

NCT05949983 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-12-23
Last updated
2025-12-31

Condition(s) studied

Breast Neoplasm

Investigational drug(s) / intervention(s)

APA ProgramRecommendations for physical activity

APA Program: Patients treated and monitored for their breast cancer following the 6-month APA program.

Recommendations for physical activity: Patients treated and monitored for their breast cancer who have received recommendations for physical activity as well as a 6-month activity schedule. To facilitate patient acceptance and participation in this study, patients who will be randomized to the control group will be offered to follow the APA program after one year of inclusion

Study summary

Adapted physical activity (APA) was recognized as a non-drug therapy by the French Health Authority (HAS) in 2011. Very few studies have examined the efficiency of APA programs during the active phase of treatment in cancer patients. The investigators assumed that non-drug therapy such as APA could improve the quality of life and reduces health costs. The main objective of this study is to assess the efficiency of a standardized APA program, as compared to conventional management including simple recommendations for the practice of physical activity in women in phase active breast cancer treatment.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * women with breast cancer * any type of breast cancer, all grades, all stages * during treatment: surgery +/- chemotherapy +/- radiotherapy +/- hormone therapy Exclusion Criteria: * World Health Organization (WHO) 4 * Unstable angina * Uncontrolled Atrial fibrillation * Uncontrolled high blood pressure * Recent myocardial infarction or myocarditis or pericarditis or thromboembolic disease (less than 3 weeks) * Aortic stenosis or valve disease to operate * Cardiac or respiratory failure, with dyspnea at rest * Symptomatic anemia, thrombocytopenia * Lytic or painful bone metastases, Severe osteoporosis * Severe infectious syndrome, * Surgery in the last 3 weeks * Extreme fatigue, sharp pain, dizziness, disturbance of consciousness, severe undernutrition * Contraindication to the practice of an adapted physical activity programme * Currently involved or exclusion period of a interventional study or adapted Physical Activity program * Patient with protective measures (guardianship, curators, and deprivation of liberty). * Pregnancy or breastfeeding * Patient with severe functional limitations

Primary outcome measure(s)

  • Comparison of physical activity programmes — 12 months
    Evaluation of the differential cost-utility ratio (cost / QALY), according to the perspective of the community over a 12-month period, of an adapted physical activity program (APA) in comparison to conventional care, including simple recommendations for physical activity for patients with breast cancer during the active phase of treatment.

Trial sites (1)

FacilityCityRegionStatus
Marie-Eve Rougé-Bugat Toulouse France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05949983 on ClinicalTrials.gov ↗ ← All trials in France