EmpowerHer: Hybrid Digital Intervention for Breast Cancer Survivors

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

Overview

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.

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.

Interventions

• Behavioral EmpowerHer Hybrid Program
  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.

Primary outcome measures

• Health-Related Quality of Life (HRQoL) [Time frame: Baseline (Week 0), Post-intervention (Week 12), and Follow-up (Week 24)]

Secondary outcome measures (8)

• Physical Activity Levels [Time frame: Baseline (Week 0), Post-intervention (Week 12), and Follow-up (Week 24)]
• Lower-Body Muscular Strength (30-second Sit-to-Stand Test) [Time frame: Baseline (Week 0), Post-intervention (Week 12), and Follow-up (Week 24)]
• Upper-Body Muscular Strength (30-second Arm Curl Test) [Time frame: Baseline (Week 0), Post-intervention (Week 12), and Follow-up (Week 24)]
• Transitional Mobility and Core Strength (30-second Lie-to-Sit Test) [Time frame: Baseline (Week 0), Post-intervention (Week 12), and Follow-up (Week 24)]
• Intervention Feasibility 1 (Exercise Session Adherence) [Time frame: Post-intervention (Week 12)]
• Intervention Feasibility 2 (Motivational Session Adherence) [Time frame: Post-intervention (Week 12)]
• Intervention Adoption (Active Mobile Application Engagement) [Time frame: Post-intervention (Week 12)]
• Intervention Acceptability (System Usability Scale) [Time frame: Post-intervention (Week 12)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

Spain · 1 center

• Department of Physiotherapy, Faculty of Physiotherapy, University of Valencia — Valencia

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 patie PMID 29395269
• Bray 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
• Proctor 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
• Lein 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
• Sprangers 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
• Aaronson 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 8433390
• Schulz 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 20334632
• Chan 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 23295957

Identifiers

NCT: NCT07676591 · 2026-FIS-4332658 · 101185004-EPP-1-2024-1-ES-SPO-

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗