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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Toulouse

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

women with breast cancer

any type of breast cancer, all grades, all stages

during treatment: surgery +/- chemotherapy +/- radiotherapy +/- hormone therapy

Disqualifiers

World Health Organization (WHO) 4

Unstable angina

Uncontrolled Atrial fibrillation

Uncontrolled high blood pressure

Trial design

Design model

Parallel

Treatments tested in this trial

  • APA Program

    Other intervention

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

  • Recommendations for physical activity

    Other intervention

    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

Treatment groups

866 Participants
are divided into 2 treatment groups
Group A: APA program GroupExperimental treatment 1 intervention
Group B: Physical activity recommendation GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
12 months

Secondary outcomes

1

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".

Time frame
12 months
2

Clinical efficacy

Progression-free survival measured for non-metastatic (relapse-free survival) and metastatic (progression-free survival) patients

Time frame
12 months
3

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".

Time frame
12 months
4

Society impact (interview)

Zarit-Burden Interview

Time frame
12 months

Other outcomes

Sponsors and contacts

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