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

January 29, 2026 updated by: Gabriela Ilie

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Queen Elizabeth II Health Sciences Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

Participants must meet all of the following criteria:

  1. Age ≥ 18 years.
  2. Diagnosis: Biopsy-confirmed invasive breast cancer.
  3. Treatment Plan: Scheduled to undergo breast cancer surgery, with or without neoadjuvant chemotherapy.
  4. Medical Safety for Exercise: Able to safely participate in low-to-moderate physical activity and light resistance training based on study screening. Participants with a history of myocardial infarction, stroke, or other significant cardiovascular conditions within the last 12 months require documented medical clearance from a Family Physician, Oncologist, or Cardiologist.
  5. Residence: Resides in Nova Scotia and able to participate in a province-wide, digitally delivered program.
  6. Digital Access and Literacy: Regular access to email and the internet on a computer, tablet, or smart phone. Able to open emailed links and navigate online videos and surveys (caregiver assistance permitted). Has an active email account or willingness to create one and check it daily.
  7. Language Ability: Able to read, speak, and understand English sufficiently to follow program content and complete study questionnaires.
  8. Study Participation Requirements: Willing and able to complete online questionnaires at baseline, 6 months, and 12 months. Willing to complete weekly self-reported compliance surveys during the 6-month intervention period.

Exclusion Criteria

Participants will be excluded if any of the following apply:

  1. Medical Contraindications: Myocardial infarction, stroke, or other major cardiovascular event within the past 12 months without medical clearance indicating safety for exercise. Any medical, orthopedic, neurological, or other condition that would preclude safe participation in a home-based physical activity program.
  2. Digital Access Limitations: Inability to access the internet or lack of a device necessary to receive daily emails or view program videos. Inability to navigate online videos or survey links, even with caregiver assistance.
  3. Participation Limitations: Unwillingness or inability to complete required questionnaires or engage with digitally delivered program components.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early Intervention (Experimental)
Participants randomized to the Early Intervention arm will begin the Breast Cancer Patient Empowerment Program (Breast Cancer PEP) immediately after baseline assessment. The 6-month, home-based digital program includes daily emails with structured physical activity guidance, arm and shoulder rehabilitation exercises, mindfulness practices, and lifestyle education modules, along with optional peer-support check-ins and monthly videoconference sessions. Participants complete weekly self-report compliance surveys throughout the 6-month program.
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.
Active Comparator: Delayed Intervention / Wait-List Control (Active Comparator)
Participants randomized to the Delayed Intervention arm receive usual care for the first 6 months following baseline assessment. No program materials or intervention content are provided during this period. At approximately 6 months, participants complete follow-up assessments and then begin the same 6-month Breast Cancer Patient Empowerment Program (Breast Cancer PEP) as the Early Intervention arm, including daily digital content, rehabilitation exercises, mindfulness practices, lifestyle modules, optional peer-support, and monthly videoconference sessions.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of participants with clinically significant psychological distress (Kessler Psychological Distress Scale-10 ≥20)
Time Frame: 6 months after randomization (Day 183 ± 2 days)
Proportion of participants scoring ≥20 on the Kessler Psychological Distress Scale-10 (K10) at 6 months after randomization. The K10 is a validated 10-item measure of psychological distress with scores ranging from 10-50, where higher scores indicate worse distress.
6 months after randomization (Day 183 ± 2 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in psychological distress (Kessler Psychological Distress Scale-10 total score)
Time Frame: Baseline to 6 months; baseline to 12 months
Change in total score on the Kessler Psychological Distress Scale-10 (K10) from baseline to 6 and 12 months. The K10 ranges from 10-50, with higher scores indicating worse distress. This outcome complements the primary binary measure by assessing psychological distress as a continuous variable.
Baseline to 6 months; baseline to 12 months
Change in health-related quality of life (SF-12v2 Physical and Mental Component Scores)
Time Frame: Baseline to 6 months; baseline to 12 months
Change in SF-12v2 Physical Component Summary (PCS) and Mental Component Summary (MCS) scores from baseline to 6 and 12 months. Scores range from 0-100, with higher scores indicating better health status.
Baseline to 6 months; baseline to 12 months
Change in health utility score (SF-6D)
Time Frame: Baseline to 6 months; baseline to 12 months
Change in SF-6D health utility score derived from SF-12v2 responses. Scores range from approximately 0.29-1.00, with higher scores indicating better health-related quality of life.
Baseline to 6 months; baseline to 12 months
Change in cancer-specific quality of life (EORTC QLQ-C30)
Time Frame: Baseline to 6 months; Baseline to 12 months.
Change in EORTC QLQ-C30 domain scores. All scales transformed to 0-100. Higher scores indicate better functioning for functional scales and worse symptoms for symptom scales; higher global health = better QoL.
Baseline to 6 months; Baseline to 12 months.
Change in breast cancer-specific quality of life (EORTC QLQ-BR23)
Time Frame: Baseline to 6 months; Baseline to 12 months.
Change in QLQ-BR23 domain scores (0-100). Higher functional scores indicate better functioning; higher symptom scores indicate worse symptoms.
Baseline to 6 months; Baseline to 12 months.
Change in self-efficacy (Self-Efficacy for Managing Chronic Disease 6-item Scale)
Time Frame: Baseline to 6 months; baseline to 12 months
Change in SEMCD-6 total score. Scores range 1-10; higher scores indicate greater self-efficacy.
Baseline to 6 months; baseline to 12 months
Change in patient activation (Patient Activation Measure-13)
Time Frame: Baseline to 6 months; baseline to 12 months
Change in PAM-13 total score. Scores range 0-100; higher scores indicate greater activation.
Baseline to 6 months; baseline to 12 months
Change in generalized anxiety symptoms (GAD-7)
Time Frame: Baseline to 6 months; baseline to 12 months

Change in GAD-7 total score. Scores range 0-21; higher scores indicate greater anxiety.

Time Frame: Baseline to 6 months; Baseline to 12 months.
Baseline to 6 months; baseline to 12 months
Change in cognitive function (PROMIS® Short Form v2.0 - Cognitive Function 8a)
Time Frame: Baseline to 6 months; baseline to 12 months
Change in PROMIS Cognitive Function 8a T-score. T-scores typically range ~20-80; higher T-scores indicate better cognitive function.
Baseline to 6 months; baseline to 12 months
Change in upper-limb disability and symptoms (QuickDASH)
Time Frame: Baseline to 6 months; baseline to 12 months
Change in QuickDASH total score. Scores range 0-100; higher scores indicate greater disability/symptoms (worse function).
Baseline to 6 months; baseline to 12 months
Change in menopause symptoms (Menopause Quick 6)
Time Frame: Baseline to 6 months; baseline to 12 months
Change in MQ-6 total score (6 items; scale scoring varies by version). Higher scores indicate more severe menopause symptoms.
Baseline to 6 months; baseline to 12 months
Change in social support (Medical Outcomes Study Social Support Survey)
Time Frame: Baseline to 6 months; baseline to 12 months
Change in MOS-SSS summary score (and/or subscales). Scores transformed to 0-100; higher scores indicate greater perceived social support.
Baseline to 6 months; baseline to 12 months
Change in body weight (self-reported kilograms)
Time Frame: Baseline to 6 months; baseline to 12 months
Change in participant self-reported body weight (kg) from baseline to 6 and 12 months.
Baseline to 6 months; baseline to 12 months
Change in diet quality (Rapid Eating Assessment for Participants - Shortened v2)
Time Frame: Baseline to 6 months; baseline to 12 months
Change in REAP-S v2 total score. Scores range from 0-60; higher scores indicate healthier dietary habits.
Baseline to 6 months; baseline to 12 months
Self-reported adherence to cancer treatment
Time Frame: Baseline to 6 months; baseline to 12 months
Proportion of participants reporting full adherence to prescribed cancer treatment(s) via questionnaire.
Baseline to 6 months; baseline to 12 months
Clinically verified adherence to cancer treatment
Time Frame: Baseline to 6 months; baseline to 12 months
Proportion of participants documented as adherent in medical records.
Baseline to 6 months; baseline to 12 months
Number of hospitalizations (administrative data)
Time Frame: Baseline to 6 months; baseline to 12 months
Count of all-cause hospitalizations per participant from linked administrative data.
Baseline to 6 months; baseline to 12 months
Number of physician billing events (administrative data)
Time Frame: Baseline to 6 months; baseline to 12 months
Count of physician billing events per participant from linked provincial administrative databases.
Baseline to 6 months; baseline to 12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant satisfaction with program components (0-10 rating scale)
Time Frame: At 6 months (post-intervention)
Participant-reported satisfaction with individual components of the Breast Cancer PEP program, assessed via a post-intervention survey. Each component (e.g., aerobic exercise, diet, mindfulness practices) is rated on a 0-10 Likert-type scale, where 0 = not at all helpful and 10 = extremely helpful.
At 6 months (post-intervention)
Participant adherence to program activities (weekly self-report surveys)
Time Frame: Throughout 6-month intervention
Percentage of prescribed weekly PEP activities completed, based on participant self-report surveys.
Throughout 6-month intervention
Change in physical activity (self-reported minutes per week)
Time Frame: Baseline to 6 months; baseline to 12 months
Change in self-reported weekly minutes of moderate-to-vigorous physical activity.
Baseline to 6 months; baseline to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gabriela Ilie

Collaborators

Nova Scotia Health Authority
Dalhousie University
Queen Elizabeth II Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 15, 2026

Primary Completion (Estimated)

March 15, 2028

Study Completion (Estimated)

March 15, 2029

Study Registration Dates

First Submitted

November 21, 2025

First Submitted That Met QC Criteria

January 29, 2026

First Posted (Actual)

February 6, 2026

Study Record Updates

Last Update Posted (Actual)

February 6, 2026

Last Update Submitted That Met QC Criteria

January 29, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BreastCancerPEP-RCT-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Breast Cancer

Clinical Trials on Breast Cancer Patient Empowerment Program (BreastCancerPEP)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe