Breast CancerEmpowerHerNCT07676591
EmpowerHer: Hybrid Digital Intervention for Breast Cancer Survivors
A study testing EmpowerHer Hybrid Program in people with Breast Cancer and Cancer Survivors, run by University of Valencia at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer, Cancer Survivors, Quality of Life
- What is being tested?
- EmpowerHer Hybrid Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 147 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jul 2027to 30 Jun 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia
Valencia, Valencia, 46010
Lirios Dueñas Moscardó, PhD, +34 655525373, lirios.duenas@uv.es
Nicole V Zurita Round, M.Sc., +34 692560205, nicole.zurita@uv.es
About this study
Official title: EmpowerHer: Protocol for a Multicentre Randomized Controlled Trial Evaluating a Hybrid Digital Exercise and Education Intervention for Breast Cancer Survivors Across Five European Countries
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:
Read more
- 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.
Read the detailed description
METHODOLOGICAL DESIGN AND STANDARDIZATION This study is a multicentre, parallel-group, randomized controlled trial (RCT) with a 1:1 allocation ratio conducted across five European countries: Spain, Poland, Ireland, the Netherlands, and Greece. The protocol follows the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidelines. To ensure consistency across all five clinical sites, all physical activity facilitators and researchers will undergo standardized training regarding the delivery of the hybrid program, data collection procedures, and participant safety monitoring prior to study initiation.
RANDOMIZATION AND BLINDING Following baseline assessments, eligible participants will be randomly assigned to either the hybrid digital-facilitator intervention group or the usual care control group. Randomization will be performed using a centralized web-based computerized system to ensure allocation concealment. Due to the nature of the exercise and lifestyle intervention, participants and exercise facilitators cannot be blinded to group assignment. However, outcome assessors responsible for performing the physical and functional tests, as well as the data analysts, will remain strictly blinded to the allocation groups throughout the study.
SAMPLE SIZE CALCULATION The total sample size was determined based on the primary outcome measure (health-related quality of life). To detect a statistically significant and clinically meaningful difference between the intervention and control groups, assuming a statistical power of 80% (1 - beta = 0.80) and a significance level of 5% (alpha = 0.05), a minimum sample size of 118 participants is required. Accounting for an anticipated dropout and attrition rate of approximately 20% over the 12-week intervention and the subsequent 3-month follow-up period, the final recruitment target was established at 147 participants (approximately 29 to 30 participants per country site).
STATISTICAL ANALYSIS PLAN Data will be analyzed using an intention-to-treat (ITT) approach, ensuring that all randomized participants are included in their originally assigned groups regardless of compliance or dropouts. Missing data will be handled using appropriate imputation techniques (e.g., multiple imputation). Descriptive statistics will characterize the sample's baseline demographics and clinical variables. To evaluate the effectiveness of the intervention over time (baseline, 12 weeks, and 3-month follow-up) and between groups, linear mixed-effects models will be utilized. These models will account for the multicentre nature of the trial by treating the study site as a random or fixed effect as appropriate. Statistical significance will be set a priori at p < 0.05.
- Conditions
- Breast Cancer, Cancer Survivors, Quality of Life, Exercise Therapy, Social Support, Mobile Applications
- Being tested
- EmpowerHer Hybrid Program
- Keywords
- Breast Cancer Survivors, Exercise Therapy, Digital Health, Mobile Applications, Social Support, Multicentre Randomized Controlled Trial, Quality of Life
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EmpowerHer Hybrid ProgramBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: EmpowerHer Program | Experimental | 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. Receives: Behavioral: EmpowerHer Hybrid Program |
| Control Group: Usual Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Week 0), Post-intervention (Week 12), and Follow-up (Week 24)
Secondary outcomes (8)
Physical Activity Levels
Measured using the International Physical Activity Questionnaire (IPAQ). The primary metric will be weekly minutes of moderate-to-vigorous physical activity (MVPA). Total MET-minutes/week will also be calculated. Higher values indicate greater physical activity engagement.
Measured: Baseline (Week 0), Post-intervention (Week 12), and Follow-up (Week 24)
Lower-Body Muscular Strength (30-second Sit-to-Stand Test)
Assessed using the 30-second Sit-to-Stand test. This test measures the number of times a participant can fully stand up from a seated position on a standard chair (44 cm seat height) and sit down again within a 30-second time limit, keeping their arms folded across their chest. Higher repetitions indicate greater lower-body muscular strength and functional mobility.
Measured: Baseline (Week 0), Post-intervention (Week 12), and Follow-up (Week 24)
Upper-Body Muscular Strength (30-second Arm Curl Test)
Assessed using the 30-second Arm Curl test. Participants are required to perform as many biceps curls as possible in 30 seconds while sitting on a chair, using a 2 kg dumbbell in their dominant hand (with the arm moving through a full range of motion from complete extension to complete flexion). Higher repetitions indicate greater upper-body muscular strength and muscular endurance.
Measured: Baseline (Week 0), Post-intervention (Week 12), and Follow-up (Week 24)
Transitional Mobility and Core Strength (30-second Lie-to-Sit Test)
Assessed using the 30-second Lie-to-Sit test, a functional assessment task designed to evaluate transitional mobility. The test measures the maximum number of repetitions a participant can complete within 30 seconds moving from a fully supine position (lying on a flat treatment table or mat) to a fully upright seated position. Higher repetitions reflect better transitional mobility, trunk control, and core strength.
Measured: Baseline (Week 0), Post-intervention (Week 12), and Follow-up (Week 24)
Intervention Feasibility 1 (Exercise Session Adherence)
Measures the feasibility of the intervention, defined as the percentage of prescribed exercise sessions completed by the participants over the 12-week intervention period. This will be calculated as the number of completed sessions divided by the total number of prescribed sessions (24 sessions in total, 2 sessions per week), multiplied by 100. Higher percentages indicate greater feasibility and adherence.
Measured: Post-intervention (Week 12)
Intervention Feasibility 2 (Motivational Session Adherence)
Measures the feasibility of the face-to-face component of the intervention, defined as the percentage of weekly facilitator-led, in-person motivational and educational sessions attended by the participants in community settings over the 12-week intervention period. This will be calculated as the number of attended in-person sessions divided by the total number of scheduled sessions (12 sessions in total, 1 session per week), multiplied by 100. Higher percentages indicate greater feasibility and adherence to the face-to-face community component.
Measured: Post-intervention (Week 12)
Intervention Adoption (Active Mobile Application Engagement)
Adoption will be operationalized as active engagement with the intervention through the mobile application. This will include participant-reported interaction with key app features, such as completion of daily wellbeing check-ins (e.g., sleep, energy). Additional indicators such as session-rated perceived exertion (sRPE) and self-reported enjoyment of activities will also be recorded as complementary measures of engagement.
Measured: Post-intervention (Week 12)
Intervention Acceptability (System Usability Scale)
Assesses the acceptability of the digital health platform using the System Usability Scale (SUS). The SUS is a 10-item questionnaire with five response options ranging from "strongly disagree" (0) to "strongly agree" (4). The overall score is calculated, normalized, and converted to a final scale ranging from 0 to 100. Higher scores indicate greater usability, friendliness, and acceptability of the mobile application (with scores above 68 considered acceptable).
Measured: Post-intervention (Week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start1 Jul 2027 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 147 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Collaborators
- European Platform for Sport Innovation (EPSI), Surpass Sport Systems, Olympiacos SFP, Cluster Sports and Technology (CST), European Platform for Sport Innovation, Poznań Supercomputing and Networking Center (PCSS)
- Responsible party
- Principal investigator, Lirios Dueñas, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676591
- Sponsor's protocol ID
- 2026-FIS-4332658
- Other IDs
- 101185004-EPP-1-2024-1-ES-SPO-
- Acronym
- EmpowerHer
- Status last verified
- Jun 2026
- First submitted
- 23 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 29395269Bray 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.
PubMed 38572751Proctor 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.
PubMed 20957426Lein 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.
PubMed 35949374Sprangers 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.
PubMed 8874337Aaronson 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.
PubMed 8433390Schulz 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.
PubMed 20334632Chan 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.
PubMed 23295957