NCT05949983

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
866

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Dec 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress47%
Dec 2024Dec 2027

First Submitted

Initial submission to the registry

June 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 18, 2023

Completed
1.4 years until next milestone

Study Start

First participant enrolled

December 23, 2024

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

December 31, 2025

Status Verified

December 1, 2025

Enrollment Period

2.9 years

First QC Date

June 13, 2023

Last Update Submit

December 23, 2025

Conditions

Breast Neoplasm

Keywords

Physical ActivityExerciseExercise TherapyBreast NeoplasmsMedical costsHealthcare Costs

Outcome Measures

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.

    12 months

Secondary Outcomes (10)

  • Breast cancer-specific quality of life

    12 months

  • Clinical efficacy

    12 months

  • Efficacy on specific functions

    12 months

  • Society impact (interview)

    12 months

  • Society impact

    12 months

  • +5 more secondary outcomes

Study Arms (2)

APA program Group

EXPERIMENTAL

patients treated and monitored for breast cancer under the APA programme

Other: APA Program

Physical activity recommendation Group

ACTIVE COMPARATOR

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

Other: Recommendations for physical activity

Interventions

APA ProgramOTHER

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

APA program Group
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

Physical activity recommendation Group

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women with breast cancer
  • any type of breast cancer, all grades, all stages
  • during treatment: surgery +/- chemotherapy +/- radiotherapy +/- hormone therapy

You may not qualify if:

  • 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
  • Patient with protective measures (guardianship, curators, and deprivation of liberty).
  • Pregnancy or breastfeeding
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marie-Eve Rougé-Bugat

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Marie-Eve Rougé-Bugat, MD

    University Toulouse

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie-Eve Rougé-Bugat, MD

CONTACT

5 61 80 01 23marieeve.rouge-bugat@dumg-toulouse.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2023

First Posted

July 18, 2023

Study Start

December 23, 2024

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

December 31, 2025

Record last verified: 2025-12

Locations

FR(1)