Health Economic Evaluation of an Adapted Physical Activity Program for Women With Breast Cancer
NCT ID: NCT05949983
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
866 participants
INTERVENTIONAL
2024-12-23
2027-12-31
Brief Summary
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Detailed Description
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Adapted physical activity (APA) was recognized as a non-drug therapy by the HAS in 2011. It reduces certain side effects of treatments, as well as certain symptoms linked to the catabolic activity of the disease such as: fat gain, loss of muscle mass, physical deconditioning, fatigue or pain. For breast cancer, a meta-analysis showed that APA following adjuvant therapy may have a beneficial effect on quality of life. The APA shows in particular for breast cancer, a reduction in all-cause mortality as well as specific mortality and a reduction in recurrence.The prescription of APA has been allowed since the 2016 health law but there is no coverage by the French national health insurance fund (CNAM) despite the benefits shown. APA is only accessible in a few centers in France that have chosen to offer it to patients, thus creating social inequalities in health.
Very few studies have examined the efficiency of APA programs during the active phase of treatment. They related to cohorts of 60 to 165 patients and uses different methods. The investigators decided to set up a study that can measure the efficiency of the standardized APA programs offered to patients diagnosed with breast cancer, assuming that non-drug therapy such as APA would improve the quality of life while reducing health costs.
Description of the procedures: The intervention consists of an initial consultation appointment with a medical check-up and physical tests, then inclusion in the standardized APA program for 6 months. The control group will be offered the same initial consultation appointment with medical check-up and physical tests and will receive recommendations for physical practice as well as a calendar of activities to be practiced independently for 6 months. Inclusion in the APA program will be offered one year after inclusion.
Follow-up: The data will be collected at T0, T + 3 months, T + 6 months, T + 9 months and T + 12 months in both arms. There will be 1 year of data analysis.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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APA program Group
patients treated and monitored for breast cancer under the APA programme
APA Program
Patients treated and monitored for their breast cancer following the 6-month APA program.
Physical activity recommendation Group
patients treated and monitored for breast cancer who have received recommendations for physical activity
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* any type of breast cancer, all grades, all stages
* during treatment: surgery +/- chemotherapy +/- radiotherapy +/- hormone therapy
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Marie-Eve Rougé-Bugat, MD
Role: PRINCIPAL_INVESTIGATOR
University Toulouse
Locations
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Marie-Eve Rougé-Bugat
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Marie-Eve Rougé-Bugat, MD
Role: primary
Other Identifiers
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RC31/21/0339
Identifier Type: -
Identifier Source: org_study_id
2022-A00017-36
Identifier Type: OTHER
Identifier Source: secondary_id