Clinical trial · Interventional
Impact of Personalized and Remote Support Centered on Exercise and Physical Activity for Breast Cancer Patients
Randomized Study Estimating the Impact of a Personalized and Remote Support Centered on Exercise and Physical Activity for Patients After Breast Cancer
NCT04536584CI-TRIAL-00105869eMOUVOIRcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A study that evaluates the benefits of a personalized remote exercise and physical activity coaching compared with the standard supportive approach in terms of health-related quality of life at 12 months in breast cancer survivors treated in an adjuvant setting.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Personalized Coaching (Arm A) | Other | — | UNRESOLVED |
| Standard supportive approach (Arm B) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A: personalized coaching for physical activities
- description
- This arm consists of providing patients with a personalized coaching focused on exercise and physical activity, with or without connected watch.
- interventionNames
- Other: Personalized Coaching (Arm A)
- type
- ACTIVE_COMPARATOR
- label
- Arm B: standard supportive approach
- description
- The standard supportive approach will consist in recommendations made during visits with the oncologist. The delivery of post-treatment care by oncologists and their team systematically provide exercise advice patients including recommendations for strength training and aerobic activity.
- interventionNames
- Other: Standard supportive approach (Arm B)
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient ≥18; * Diagnosis of invasive non-metastatic breast cancer; * 5 months (+/- 3 months) after the end of the treatment by surgery and/or radiotherapy and/or chemotherapy and/or other "short-term" systemic treatment : immunotherapy, PARP inhibitor, trastuzumab or TDM1 ; the continuation of hormonotherapy (more or less associated with an anti-CDK4/6), trastuzumab or TDM1 is possible during the study period; * SF-36 filled in completely * Medical certificate for sports practice delivered by a healthcare professional or oncologist. Neither the previous sports practice, nor the motivation for the proposed program is necessary to participate in the program. * Agreement for follow-ups during the study period lasting 12 months; * Ability to understand, read and write French; * Patient covered by the French "Social Security" regime; * Signed informed consent for the participation in the study, including the randomization with a 50%/50% chance of being allocated to one or the other group. Exclusion Criteria: * Relapse of invasive breast cancer (loco-regional relapse, contralateral relapse) * Inability to exercise because of a severe handicap or vulnerability. These contraindications are left to the discretion of the healthcare professional assessing capacity (ex : severe malnutrition, pregnancy …); * Metastatic cancer; * Expressed preference for one arm; * Inability to comply with follow-up (4 and 12 months) of the trial (geographical, social, medical or psychological reasons); * Person under guardianship or curatorship.
References
Publications (0)
Data not yet available
No reference posted for this study.