Clinical trial · Interventional
Efficacy of Exercise Using Connected Activity Trackers and Therapeutic Education in Localized Breast Cancer
Randomized Controlled Trial Evaluating the Efficacy of an Adapted Physical Activity Program Using a Connected Device With Activity Trackers and a Therapeutic Education Program Among Women With Localized Breast Cancer
- 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)
The 3-year DISCO study aims to systematically implement physical activity in breast cancer patients. The primary objective is to investigate the efficacy of a connected device (personalized non-supervised exercise program including a wristband as activity tracker, a smartphone application, and a website) and the efficacy of a therapeutic education program on the physical activity level of patients at the end of the 6-month programs. The research hypothesis is that patients participating in the intervention with the connected device or in the therapeutic education program will achieve the international recommendations in terms of physical activity, compared to women receiving only physical activity recommendations.
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Connected device | Device | — | UNRESOLVED |
| Therapeutic education | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Connected device
- description
- Women randomized to the "connected device" arm will follow a 6-month exercise program using a connected device that includes an activity tracker and subscription to an exercise and physical activity management program through a smartphone application and a website. They will also receive international recommendations on physical activity.
- interventionNames
- Device: Connected device
- type
- EXPERIMENTAL
- label
- Therapeutic education
- description
- Women randomized to the "therapeutic education" arm will follow a 6-month program of therapeutic patient education. They will also receive international recommendations on physical activity.
- interventionNames
- Behavioral: Therapeutic education
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Female between 18 and 75 years old, * Being diagnosed with a first primary non-metastatic invasive breast carcinoma, that has been histologically confirmed, * Having been operated and requiring the prescription of an adjuvant treatment (chemotherapy, hormonotherapy, radiotherapy), * Whose adjuvant treatment will be prescribed (for hormone therapy) or carried out (for chemotherapy and radiotherapy) in one of the investigating centers, * Being able to practice adapted physical activity and providing a medical certificate of no contraindications to exercise issued by the investigator physician, the general practitioner, or the referring physician, * Available and willing to participate in the study for the duration of the interventions and follow-up, * Using a personal smartphone compatible with the application (iOS operating system from version 9.3, Android operating system from version 5.0, no Microsoft operating system) and having Internet access on a computer, * Able to understand, read, and write French, * Affiliated with a social security scheme, * Having dated and signed an informed consent. Exclusion Criteria: * Woman with recurrent, metastatic, or inflammatory breast cancer, * Personal history or co-existence of another primary cancer (except of in situ cancer regardless of the site and/or basal cell skin cancer and/or non-mammary cancer in complete remission for more than 5 years), * Presenting a contraindication to exercise according to the investigator (such as cardiorespiratory or bone pathologies, non-stabilized chronic diseases such as diabetes, malnutrition, etc.), * In a state of severe malnutrition according to the criteria of the French National Health Authority (i.e., in women ≤ 70 years: weight loss ≥ 15% in 6 months or ≥ 10% in 1 month; in women \> 70 years: weight loss ≥ 15% in 6 months or ≥ 10% in 1 month, and body mass index \< 18 kg/m²), * Unable to be followed for medical, social, family, geographic or psychological reasons for the duration of the study, * Participating in simultaneous physical activity studies, * Deprived of their liberty by court or administrative decision, * Pregnant or breastfeeding or of childbearing age without effective contraception for the duration of the study.
References
Publications (11)
- BACKGROUNDBeasley JM, Kwan ML, Chen WY, Weltzien EK, Kroenke CH, Lu W, Nechuta SJ, Cadmus-Bertram L, Patterson RE, Sternfeld B, Shu XO, Pierce JP, Caan BJ. Meeting the physical activity guidelines and survival after breast cancer: findings from the after breast cancer pooling project. Breast Cancer Res Treat. 2012 Jan;131(2):637-43. doi: 10.1007/s10549-011-1770-1. Epub 2011 Sep 21. PMID 21935600
- BACKGROUNDBeg MS, Gupta A, Stewart T, Rethorst CD. Promise of Wearable Physical Activity Monitors in Oncology Practice. J Oncol Pract. 2017 Feb;13(2):82-89. doi: 10.1200/JOP.2016.016857. PMID 28387544
- BACKGROUNDCadmus-Bertram LA, Marcus BH, Patterson RE, Parker BA, Morey BL. Randomized Trial of a Fitbit-Based Physical Activity Intervention for Women. Am J Prev Med. 2015 Sep;49(3):414-8. doi: 10.1016/j.amepre.2015.01.020. Epub 2015 Jun 10. PMID 26071863
- BACKGROUNDFerguson T, Rowlands AV, Olds T, Maher C. The validity of consumer-level, activity monitors in healthy adults worn in free-living conditions: a cross-sectional study. Int J Behav Nutr Phys Act. 2015 Mar 27;12:42. doi: 10.1186/s12966-015-0201-9. PMID 25890168
- BACKGROUNDFerlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9. PMID 25220842
- BACKGROUNDIbrahim EM, Al-Homaidh A. Physical activity and survival after breast cancer diagnosis: meta-analysis of published studies. Med Oncol. 2011 Sep;28(3):753-65. doi: 10.1007/s12032-010-9536-x. Epub 2010 Apr 22. PMID 20411366
- BACKGROUNDLahart IM, Metsios GS, Nevill AM, Carmichael AR. Physical activity, risk of death and recurrence in breast cancer survivors: A systematic review and meta-analysis of epidemiological studies. Acta Oncol. 2015 May;54(5):635-54. doi: 10.3109/0284186X.2014.998275. Epub 2015 Mar 9.