EmpowerHer: Hybrid Digital Intervention for Breast Cancer Survivors
EmpowerHer
EmpowerHer: Protocol for a Multicentre Randomized Controlled Trial Evaluating a Hybrid Digital Exercise and Education Intervention for Breast Cancer Survivors Across Five European Countries
2 other identifiers
interventional
147
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Jul 2027
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2026
CompletedFirst Posted
Study publicly available on registry
June 30, 2026
CompletedStudy Start
First participant enrolled
July 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2028
Study Completion
Last participant's last visit for all outcomes
June 30, 2028
June 30, 2026
June 1, 2026
1 year
June 23, 2026
June 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Health-Related Quality of Life (HRQoL)
Evaluated using the European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) and its breast cancer-specific module (EORTC QLQ-BR23). The EORTC QLQ-C30 incorporates a Global Health Status/QoL scale, functional scales, and symptom scales. The QLQ-BR23 incorporates functional scales (body image, sexual functioning, sexual enjoyment, future perspective) and symptom scales (systemic therapy side effects, breast symptoms, arm symptoms, upset by hair loss). All scores are linearly transformed to a 0-100 scale. For the Global Health Status and functional scales, a higher score represents a higher/better level of functioning and quality of life. For the symptom scales, a higher score represents a higher/worse level of symptomatology or problems.
Baseline (Week 0), Post-intervention (Week 12), and Follow-up (Week 24)
Secondary Outcomes (8)
Physical Activity Levels
Baseline (Week 0), Post-intervention (Week 12), and Follow-up (Week 24)
Lower-Body Muscular Strength (30-second Sit-to-Stand Test)
Baseline (Week 0), Post-intervention (Week 12), and Follow-up (Week 24)
Upper-Body Muscular Strength (30-second Arm Curl Test)
Baseline (Week 0), Post-intervention (Week 12), and Follow-up (Week 24)
Transitional Mobility and Core Strength (30-second Lie-to-Sit Test)
Baseline (Week 0), Post-intervention (Week 12), and Follow-up (Week 24)
Intervention Feasibility 1 (Exercise Session Adherence)
Post-intervention (Week 12)
- +3 more secondary outcomes
Study Arms (2)
Intervention Group: EmpowerHer Program
EXPERIMENTALParticipants 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.
Control Group: Usual Care
NO INTERVENTIONParticipants 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.
Interventions
A 12-week hybrid physical exercise and health education program. It consists of home-based structured exercise sessions delivered via a dedicated mobile application (minimum of 2 sessions per week) combined with weekly, in-person group motivational and educational sessions led by a trained local facilitator in community settings.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Valencialead
- European Platform for Sport Innovation (EPSI)collaborator
- Surpass Sport Systemscollaborator
- Olympiacos SFPcollaborator
- Cluster Sports and Technology (CST)collaborator
- European Platform for Sport Innovationcollaborator
- Poznań Supercomputing and Networking Center (PCSS)collaborator
Study Sites (1)
Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia
Valencia, Valencia, 46010, Spain
Related Publications (8)
Allemani C, Matsuda T, Di Carlo V, Harewood R, Matz M, Niksic M, Bonaventure A, Valkov M, Johnson CJ, Esteve J, Ogunbiyi OJ, Azevedo E Silva G, Chen WQ, Eser S, Engholm G, Stiller CA, Monnereau A, Woods RR, Visser O, Lim GH, Aitken J, Weir HK, Coleman MP; CONCORD Working Group. Global surveillance of trends in cancer survival 2000-14 (CONCORD-3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population-based registries in 71 countries. Lancet. 2018 Mar 17;391(10125):1023-1075. doi: 10.1016/S0140-6736(17)33326-3. Epub 2018 Jan 31.
PMID: 29395269RESULTBray 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: 38572751RESULTProctor 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: 20957426RESULTLein 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: 35949374RESULTSprangers 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: 8874337RESULTAaronson 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.
PMID: 8433390RESULTSchulz KF, Altman DG, Moher D; CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. Trials. 2010 Mar 24;11:32. doi: 10.1186/1745-6215-11-32.
PMID: 20334632RESULTChan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
PMID: 23295957RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Due to the nature of the hybrid digital and exercise intervention, participants and exercise facilitators cannot be blinded to group allocation. However, baseline, post-intervention, and 3-month follow-up assessments will be conducted by trained personnel (outcomes assessors) who are strictly blinded to group assignment. To minimize the risk of bias, separate teams will be used for intervention delivery and outcome assessment, with restricted access to the randomization list. Additionally, data analysts will remain fully blinded throughout the trial, and datasets will be coded so that analysts cannot identify group allocation during statistical analysis.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Physiotherapy
Study Record Dates
First Submitted
June 23, 2026
First Posted
June 30, 2026
Study Start (Estimated)
July 1, 2027
Primary Completion (Estimated)
June 30, 2028
Study Completion (Estimated)
June 30, 2028
Last Updated
June 30, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data will be available beginning 6 months after publication of the primary results and will remain available for up to 5 years. Supporting documents (study protocol, statistical analysis plan, and informed consent form) will be available within the same timeframe. Data will be securely stored and managed in accordance with institutional policies and GDPR requirements.
- Access Criteria
- Access will be granted to researchers who provide a methodologically sound proposal, subject to approval by the research team and, where applicable, ethics committees. Data will be shared in anonymized form only, ensuring no participant can be identified or reidentified. A data access agreement will be required. Requests should be directed to the principal investigator, and data will be used only for purposes consistent with the approved proposal.
Individual participant data (IPD) will be shared in anonymized form. The dataset will include deidentified demographic, clinical, and outcome data underlying the reported results. All data will be irreversibly anonymized in accordance with GDPR to ensure that participants cannot be identified or reidentified. The study protocol, statistical analysis plan, and informed consent form will also be available. Data will be accessible from 6 months after publication of the primary results for up to 5 years. Access will be granted to researchers with a methodologically sound proposal, subject to approval by the research team and, where applicable, ethics committees. A data access agreement will be required, and requests should be directed to the principal investigator.