Breast NeoplasmEMEAPANCT05949983
Health Economic Evaluation of an Adapted Physical Activity Program for Women With Breast Cancer
A study testing APA Program and Recommendations for physical activity in people with Breast Neoplasm, run by University Hospital, Toulouse at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm
- What is being tested?
- APA Program and Recommendations for physical activity
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 866 participants
- Where
- 1 siteFrance
- Study dates
- 23 Dec 2024to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women with breast cancer
- any type of breast cancer, all grades, all stages
- during treatment: surgery +/- chemotherapy +/- radiotherapy +/- hormone therapy
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Marie-Eve Rougé-Bugat
Toulouse
Marie-Eve Rougé-Bugat, MD, 561800123 ext. +33, marieeve.rouge-bugat@dumg-toulouse.fr
Marie-Eve Rougé Bugat
About this study
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
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.
Read the 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.
- Conditions
- Breast Neoplasm
- Being tested
- APA Program, Recommendations for physical activity
- Keywords
- Physical Activity, Exercise, Exercise Therapy, Breast Neoplasms, Medical costs, Healthcare Costs
- Medical subject headings
- Breast Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APA ProgramOther
Patients treated and monitored for their breast cancer following the 6-month APA program.
Recommendations for physical activityOther
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
| Study group | Role | What they receive |
|---|---|---|
| APA program Group | Experimental | patients treated and monitored for breast cancer under the APA programme Receives: Other: APA Program |
| Physical activity recommendation Group | Active comparator | patients treated and monitored for breast cancer who have received recommendations for physical activity Receives: Other: Recommendations for physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (10)
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".
Measured: 12 months
Clinical efficacy
Progression-free survival measured for non-metastatic (relapse-free survival) and metastatic (progression-free survival) patients
Measured: 12 months
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".
Measured: 12 months
Society impact (interview)
Zarit-Burden Interview
Measured: 12 months
Society impact
Number of hours of informal help for basic and instrumental activities of daily life
Measured: 12 months
Patient satisfaction
Patient satisfaction questionnaire (EORTC-IN-PATSAT32) is a 32-item questionnaire. The choices range from 1 "bad" to 4 "excellent".
Measured: 12 months
Programme compliance rate
Traced by the reservation system for adapted physical activity (APA) sessions
Measured: 12 months
Rate of hospital care
Direct medical costs
Measured: 12 months
Rate of difference in the effect of the programme
Socioeconomic determinants (changes in income, socio-professional category, level of education and family environment)
Measured: 12 months
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
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start23 Dec 2024
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 866 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marie-Eve Rougé-Bugat, MD, Principal investigator, University Toulouse
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05949983
- Sponsor's protocol ID
- RC31/21/0339
- Other IDs
- 2022-A00017-36
- Acronym
- EMEAPA
- Status last verified
- Dec 2025
- First submitted
- 13 Jun 2023
- Last updated
- 31 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05949983
- Acronym / sponsor ID
- EMEAPA / RC31/21/0339
- Conditions
- Breast Neoplasm
- Keywords
- Physical Activity, Exercise, Exercise Therapy, Breast Neoplasms, Medical costs, Healthcare Costs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 866 participants (estimated)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 23 Dec 2024 (actual)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APA program Group | Experimental | Other: APA Programpatients treated and monitored for breast cancer under the APA programme |
| Physical activity recommendation Group | Active comparator | Other: Recommendations for physical activitypatients treated and monitored for breast cancer who have received recommendations for physical activity |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- women with breast cancer
- any type of breast cancer, all grades, all stages
- during treatment: surgery +/- chemotherapy +/- radiotherapy +/- hormone therapy
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APA ProgramPatients treated and monitored for their breast cancer following the 6-month APA program. | Other | APA program Group |
| Recommendations for physical activityPatients 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 | Other | Physical activity recommendation Group |
Primary outcome
Comparison of physical activity programmes
Time frame: 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.
10 secondary outcomes
Breast cancer-specific quality of life
Time frame: 12 months
Clinical efficacy
Time frame: 12 months
Efficacy on specific functions
Time frame: 12 months
Society impact (interview)
Time frame: 12 months
Society impact
Time frame: 12 months
Patient satisfaction
Time frame: 12 months
Programme compliance rate
Time frame: 12 months
Rate of hospital care
Time frame: 12 months
Rate of difference in the effect of the programme
Time frame: 12 months
Rate of financial benefit of the programme
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marie-Eve Rougé-Bugat, MD principal investigator
University Toulouse
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing APA Program and Recommendations for physical activity in people with Breast Neoplasm, run by University Hospital, Toulouse at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marie-Eve Rougé-Bugat, MD (5 61 80 01 23 ext. +33, marieeve.rouge-bugat@dumg-toulouse.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of physical activity programmes (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.