Actively Recruiting
Health Economic Evaluation of an Adapted Physical Activity Program for Women With Breast Cancer During the Active Phase of Treatment: a Randomized Controlled Trial
Led by University Hospital, Toulouse · Updated on 2025-12-31
866
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficiency of a standardized adapted physical activity (APA) program for women undergoing active breast cancer treatment. This study compares the APA program to conventional management, which includes simple recommendations for physical activity. The aim is to improve quality of life and reduce health costs during the active phase of breast cancer treatment, addressing a recognized need as APA is a non-drug therapy endorsed by the French Health Authority but not widely accessible or reimbursed. The study involves two groups: one participating in a 6-month standardized APA program with medical check-ups and physical tests, and a control group receiving the same initial consultation but only recommendations and a calendar for independent physical activity over 6 months. After one year, the control group will be offered the APA program. Data collection occurs at baseline, 3, 6, 9, and 12 months, with analysis over one year. Participants will undergo medical evaluations and physical tests at designated intervals while researchers assess multiple outcomes including quality of life, clinical efficacy, program compliance, satisfaction, hospital care rates, and financial impacts over up to five years. The primary outcome is the comparison of physical activity programs at 12 months. This comprehensive monitoring aims to assess the benefits and economic impact of APA during breast cancer treatment.
CONDITIONS
Brief Title
Health Economic Evaluation of an Adapted Physical Activity Program for Women With Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women with breast cancer
- Any type, grade, or stage of breast cancer
- Currently undergoing treatment including surgery, chemotherapy, radiotherapy, or hormone therapy
- Age 18 years or older
You will not qualify if you...
- World Health Organization (WHO) status 4
- Unstable angina
- Uncontrolled atrial fibrillation
- Uncontrolled high blood pressure
- Recent myocardial infarction, myocarditis, pericarditis, or thromboembolic disease within 3 weeks
- Aortic stenosis or valve disease requiring surgery
- Cardiac or respiratory failure with dyspnea at rest
- Symptomatic anemia or thrombocytopenia
- Lytic or painful bone metastases or severe osteoporosis
- Severe infectious syndrome
- Surgery within the last 3 weeks
- Extreme fatigue, sharp pain, dizziness, disturbance of consciousness, or severe undernutrition
- Contraindications to adapted physical activity program
- Currently involved in or within exclusion period of another interventional or adapted physical activity study
- Under protective measures such as guardianship or deprivation of liberty
- Pregnancy or breastfeeding
- Severe functional limitations
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants receive either a standardized adapted physical activity (APA) program or recommendations for physical activity to follow independently during their active breast cancer treatment.
Initial consultation with medical check-up and physical tests, followed by periodic assessments at 3 and 6 months
Duration - 6 months
Participants are monitored for an additional 6 months after the treatment period to assess ongoing outcomes and quality of life.
Assessments at 9 and 12 months after inclusion
Trial Site Locations
Total: 1 location
1
Marie-Eve Rougé-Bugat
Toulouse, France
Actively Recruiting
Research Team
M
Marie-Eve Rougé-Bugat, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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