NCT07392424

BreastCancerPEP: A Six-Month Online Empowerment Program to Improve Mental and Physical Health in Women With Breast Cancer

BreastCancerPEP: A Randomized Trial of a Six-Month Online Empowerment Program to Improve Mental and Physical Health in Women With Breast Cancer

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: Gabriela Ilie · Academic / Other
• Sex: Female
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

This study is evaluating a six-month, home-based Patient Empowerment Program (Breast Cancer PEP) for women receiving treatment for newly diagnosed invasive breast cancer. The program provides daily guidance on physical activity, arm and shoulder rehabilitation, stress-reduction practices, healthy lifestyle habits, and social support, all delivered through online videos, emails, and optional group sessions. The purpose of the study is to learn whether this program can reduce psychological distress and improve overall well-being compared with standard cancer care. Psychological distress will be measured using a simple questionnaire called the Kessler Psychological Distress Scale (K10). The study will also look at general health, quality of life, and participants' experiences with the program. A total of 160 women across Nova Scotia will take part. Participants will be randomly assigned to start the program right away or to receive standard care for six months before getting access to the program. Everyone will complete online questionnaires at the beginning of the study and again at 6 and 12 months. A small number of participants may also be invited to take part in optional interviews to share their experiences. Researchers will also explore how participants use the digital program, what parts are most helpful, and whether the program could be offered more broadly in the future. The trial is being conducted across all Nova Scotia Health zones and coordinated through the QEII Health Sciences Centre.

Detailed description

Breast Cancer PEP (BC-PEP) is a six-month, home-based, digitally delivered supportive-care program designed for individuals undergoing treatment for newly diagnosed invasive breast cancer. The program integrates physical activity, upper-limb rehabilitation, mindfulness, nutrition education, and self-management strategies. BC-PEP is based on prior PEP programs evaluated in Atlantic Canada, which demonstrated high feasibility and strong participant engagement. In this randomized, wait-list-controlled trial, participants assigned to the early-intervention arm begin the 6-month BC-PEP program immediately after randomization, while participants in the wait-list control arm receive standard care for 6 months before initiating the same program. All participants are followed for approximately 12 months to assess intervention effects and longer-term outcomes. Randomization and allocation procedures are conducted centrally, and the study is implemented across multiple Nova Scotia Health sites. Intervention Delivery: BC-PEP is delivered primarily through automated daily emails generated via REDCap over 182 consecutive days. Each email provides a structured set of activities, including: Progressive aerobic activity designed to meet oncology-specific guidelines Twice-weekly resistance-training sessions using household equipment or elastic bands Daily stretching and upper-limb rehabilitation exercises aligned with surgical recovery timelines A 10-minute daily mindfulness or relaxation practice Short educational modules addressing sleep, stress coping, communication, body image, and nutrition Participants have access to a video library with instructional content, may engage in an optional peer-support "buddy system," and are invited to monthly videoconference sessions with study clinicians. Implementation and Engagement Monitoring Engagement metrics are collected throughout the program, including weekly adherence surveys, email-open rates, video-view data, and participation in monthly sessions. Implementation outcomes will be examined using a Hybrid Type I effectiveness-implementation approach guided by the RE-AIM framework. This digital, low-cost program is designed to be scalable and accessible across diverse geographic regions. Study findings are intended to inform the effectiveness and implementation potential of BC-PEP as part of routine supportive cancer care.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Breast Cancer Patient Empowerment Program (BreastCancerPEP)	The Breast Cancer Patient Empowerment Program (Breast Cancer PEP) is a 6-month, home-based digital behavioural intervention delivered through daily automated emails containing structured physical activity guidance, resistance-band and body-weight strength training, yoga and stretching routines, arm and shoulder rehabilitation exercises, mindfulness and relaxation practices, and lifestyle education modules. Optional peer-support check-ins and monthly videoconference group sessions are included. Intervention content is standardized through a 182-day pre-programmed email and video library. Participants in both study arms receive the same intervention content, with timing dependent on randomization assignment.

Timeline

• Start date: 2026-03-15
• Primary completion: 2028-03-15
• Completion: 2029-03-15
• First posted: 2026-02-06
• Last updated: 2026-02-06

Locations

1 site across 1 country: Canada