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

Breast Neoplasm Clinical Trial

— EMEAPA  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05949983
• Other study ID #: RC31/21/0339
• Secondary ID: 2022-A00017-36
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 1, 2024
• Est. completion date: January 1, 2026

Study information

• Verified date: November 2023
• Source: University Hospital, Toulouse
• Contact: Marie-Eve Rougé-Bugat, MD
• Phone: 5 61 80 01 23
• Email: marieeve.rouge-bugat[@]dumg-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 866
• Est. completion date: January 1, 2026
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	Marie-Eve Rougé-Bugat	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of physical activity programmes	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.	12 months
Secondary	Breast cancer-specific quality of life	Breast Cancer Specific Quality of Life Questionnaire (QLQ) (BR23-QLQ-C30) is a 52-item questionnaire. The choices range from 1 "not at all" to 4 "very much".	12 months
Secondary	Clinical efficacy	Progression-free survival measured for non-metastatic (relapse-free survival) and metastatic (progression-free survival) patients	12 months
Secondary	Efficacy on specific functions	BR23-QLQ-C30 questionnaire.; Breast Cancer Specific Quality of Life Questionnaire (BR23-QLQ-C30) is a 52-item questionnaire. The choices range from 1 "not at all" to 4 "very much".	12 months
Secondary	Society impact (interview)	Zarit-Burden Interview	12 months
Secondary	Society impact	Number of hours of informal help for basic and instrumental activities of daily life	12 months
Secondary	Patient satisfaction	Patient satisfaction questionnaire (EORTC-IN-PATSAT32) is a 32-item questionnaire. The choices range from 1 "bad" to 4 "excellent".	12 months
Secondary	Programme compliance rate	Traced by the reservation system for adapted physical activity (APA) sessions	12 months
Secondary	Rate of hospital care	Direct medical costs	12 months
Secondary	Rate of difference in the effect of the programme	Socioeconomic determinants (changes in income, socio-professional category, level of education and family environment)	12 months
Secondary	Rate of financial benefit of the programme	Annual and 5-year net financial benefit of the systematic implementation of an adapted physical activity (APA) program	5 years