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

Sponsor

University Hospital, Toulouse (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05949983

Collaborator

(none)

866

Enrollment

Location

Arms

Anticipated Duration (Months)

36.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Neoplasm	Other: APA Program Other: Recommendations for physical activity	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

866 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: APA program Group patients treated and monitored for breast cancer under the APA programme	Other: APA Program Patients treated and monitored for their breast cancer following the 6-month APA program.
Active Comparator: Physical activity recommendation Group patients treated and monitored for breast cancer who have received recommendations for physical activity	Other: 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

Arm

Intervention/Treatment

Experimental: APA program Group

patients treated and monitored for breast cancer under the APA programme

Other: APA Program

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

Active Comparator: Physical activity recommendation Group

patients treated and monitored for breast cancer who have received recommendations for physical activity

Other: 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

Outcome Measures

Primary Outcome Measures

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.

Secondary Outcome Measures

Breast cancer-specific quality of life [12 months]
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".
Clinical efficacy [12 months]
Progression-free survival measured for non-metastatic (relapse-free survival) and metastatic (progression-free survival) patients
Efficacy on specific functions [12 months]
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".
Society impact (interview) [12 months]
Zarit-Burden Interview
Society impact [12 months]
Number of hours of informal help for basic and instrumental activities of daily life
Patient satisfaction [12 months]
Patient satisfaction questionnaire (EORTC-IN-PATSAT32) is a 32-item questionnaire. The choices range from 1 "bad" to 4 "excellent".
Programme compliance rate [12 months]
Traced by the reservation system for adapted physical activity (APA) sessions
Rate of hospital care [12 months]
Direct medical costs
Rate of difference in the effect of the programme [12 months]
Socioeconomic determinants (changes in income, socio-professional category, level of education and family environment)
Rate of financial benefit of the programme [5 years]
Annual and 5-year net financial benefit of the systematic implementation of an adapted physical activity (APA) program

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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