Clinical trial NCT05949983: Health Economic Evaluation of an Adapted Physical Activity Program for Women With Breast Cancer
Official title: Health Economic Evaluation of an Adapted Physical Activity Program for Women With Breast Cancer During the Active Phase of Treatment: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Neoplasm
Keywords: Physical Activity
Exercise
Exercise Therapy
Breast Neoplasms
Medical costs
Healthcare Costs
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-07-18
Enrollment: 866
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed description: Scientific rationale: The incidence of breast cancer in women is on the rise again over the period 2010-2018. The overall cost of cancer treatment is 16.8 billion euros, including 3.6 billion for drugs alone. The treatments are more and more prolonged, the proportion of anticancer drugs continues to increase with 10% of the amount reimbursed for drugs delivered in pharmacies in 2017.

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.

Eligibility criteria: 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 outcomes:
measure: Comparison of physical activity programmes
timeFrame: 12 months
Secondary outcomes:
measure: Breast cancer-specific quality of life
timeFrame: 12 months
measure: Clinical efficacy
timeFrame: 12 months
measure: Efficacy on specific functions
timeFrame: 12 months
measure: Society impact (interview)
timeFrame: 12 months
measure: Society impact
timeFrame: 12 months
measure: Patient satisfaction
timeFrame: 12 months
measure: Programme compliance rate
timeFrame: 12 months
measure: Rate of hospital care
timeFrame: 12 months
measure: Rate of difference in the effect of the programme
timeFrame: 12 months
measure: Rate of financial benefit of the programme
timeFrame: 5 years
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Marie-Eve Rougé-Bugat
Study officials:
affiliation: University Toulouse
name: Marie-Eve Rougé-Bugat, MD
role: PRINCIPAL_INVESTIGATOR
References: