EmpowerHer: Hybrid Digital Intervention for Breast Cancer Survivors

Sponsor
University of Valencia
Study ID
NCT07676591
Status
Not Yet Recruiting

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Conditions

  • Breast Cancer
  • Cancer Survivors
  • Exercise Therapy
  • Mobile Applications
  • Quality of Life
  • Social Support

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • EmpowerHer Hybrid Program — BEHAVIORAL
    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 Details

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.

Key Dates

First listed
Jun 30, 2026
Start date
Jul 1, 2027
Status verified
Jun 2026
Primary completion
Jun 30, 2028
Completion
Jun 30, 2028

Study Design

Enrollment
147 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Intervention Group: EmpowerHer Program
    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.
  • No Intervention: Control Group: Usual Care
    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 Outcome Measure

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

Central Contacts

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