Clinical trial · Interventional
EmpowerHer: Hybrid Digital Intervention for Breast Cancer Survivors
EmpowerHer: Protocol for a Multicentre Randomized Controlled Trial Evaluating a Hybrid Digital Exercise and Education Intervention for Breast Cancer Survivors Across Five European Countries
- 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 goal of this clinical trial is to learn if a 12-week hybrid exercise and education program (EmpowerHer) works to improve health-related quality of life in breast cancer survivors aged 35 to 65. The main questions it aims to answer are: * Does the EmpowerHer program improve the everyday quality of life of participants? * Does the program lower fatigue, anxiety, and depression while raising physical fitness? Researchers will compare the EmpowerHer program to usual medical care to see if the program works better to help survivors recover. Participants will: * Use a mobile application at home at least twice a week for structured exercise. * Read short educational modules on the mobile application about health after cancer. * Attend weekly in-person motivational group sessions with a program facilitator. * Complete health and physical tests at the start, at 12 weeks, and 3 months later.
Conditions
Conditions (6)
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 |
| Cancer Survivors | Breast Neoplasm | PROBABILISTIC | 0.70 |
| Exercise Therapy | — | UNRESOLVED | — |
| Mobile Applications | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Social Support | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| EmpowerHer Hybrid Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Group: EmpowerHer Program
- description
- Participants will engage in a 12-week hybrid digital-facilitator intervention. It includes home-based structured exercise via a mobile application (minimum 2 sessions per week), app-delivered educational modules, and weekly in-person motivational sessions led by a facilitator in community settings.
- interventionNames
- Behavioral: EmpowerHer Hybrid Program
- type
- NO_INTERVENTION
- label
- Control Group: Usual Care
- description
- Participants will receive usual care, defined as standard medical follow-up and general health advice typically provided by local healthcare services in routine clinical practice, without structured exercise or psychosocial support interventions during the trial.
Primary outcomes (1)
- measure
- Health-Related Quality of Life (HRQoL)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 18-65 years. * History of breast cancer. * Completed primary treatment (surgery, chemotherapy, and/or radiotherapy; adjuvant hormone therapy is permitted). * No evidence of active or metastatic disease at enrolment. * Able to provide informed consent and communicate in the local language. * Own and are able to use a smartphone. * Willing to engage in the exercise program. Exclusion Criteria: * Cognitive impairment preventing safe participation or questionnaire completion. * Uncontrolled medical conditions that contraindicate exercise (e.g., unstable cardiac disease). * Concurrently enrolled in another structured exercise or survivorship study. * Pregnant or breastfeeding.
References
Publications (8)
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- RESULTBray F, Laversanne M, Sung H, Ferlay J, Siegel RL, Soerjomataram I, Jemal A. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2024 May-Jun;74(3):229-263. doi: 10.3322/caac.21834. Epub 2024 Apr 4. PMID 38572751
- RESULTProctor E, Silmere H, Raghavan R, Hovmand P, Aarons G, Bunger A, Griffey R, Hensley M. Outcomes for implementation research: conceptual distinctions, measurement challenges, and research agenda. Adm Policy Ment Health. 2011 Mar;38(2):65-76. doi: 10.1007/s10488-010-0319-7. PMID 20957426
- RESULTLein DH Jr, Alotaibi M, Almutairi M, Singh H. Normative Reference Values and Validity for the 30-Second Chair-Stand Test in Healthy Young Adults. Int J Sports Phys Ther. 2022 Aug 1;17(5):907-914. doi: 10.26603/001c.36432. eCollection 2022. PMID 35949374
- RESULTSprangers MA, Groenvold M, Arraras JI, Franklin J, te Velde A, Muller M, Franzini L, Williams A, de Haes HC, Hopwood P, Cull A, Aaronson NK. The European Organization for Research and Treatment of Cancer breast cancer-specific quality-of-life questionnaire module: first results from a three-country field study. J Clin Oncol. 1996 Oct;14(10):2756-68. doi: 10.1200/JCO.1996.14.10.2756. PMID 8874337
- RESULTAaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.