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

NCT07392424 | Not Yet Recruiting

• 1 other identifier: BreastCancerPEP-RCT-2026
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

empowerment; mental health; patient activation; health promotion; breast cancer; quality of life; psychological distress; digital health; self-management; patient-reported outcomes; patient-centred care; lifestyle intervention; cancer survivorship

Outcome Measures

Primary Outcomes (1)

• Proportion of participants with clinically significant psychological distress (Kessler Psychological Distress Scale-10 ≥20)

  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 Outcomes (18)

• Change in psychological distress (Kessler Psychological Distress Scale-10 total score)

  Baseline to 6 months; baseline to 12 months

• Change in health-related quality of life (SF-12v2 Physical and Mental Component Scores)

  Baseline to 6 months; baseline to 12 months

• Change in health utility score (SF-6D)

  Baseline to 6 months; baseline to 12 months

• Change in cancer-specific quality of life (EORTC QLQ-C30)

  Baseline to 6 months; Baseline to 12 months.

• Change in breast cancer-specific quality of life (EORTC QLQ-BR23)

  Baseline to 6 months; Baseline to 12 months.

Other Outcomes (3)

• Participant satisfaction with program components (0-10 rating scale)

  At 6 months (post-intervention)

• Participant adherence to program activities (weekly self-report surveys)

  Throughout 6-month intervention

• Change in physical activity (self-reported minutes per week)

  Baseline to 6 months; baseline to 12 months

Study Arms (2)

Early Intervention (Experimental)

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)

Delayed Intervention / Wait-List Control (Active Comparator)

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)

Interventions

Breast Cancer Patient Empowerment Program (BreastCancerPEP) BEHAVIORAL

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.

Delayed Intervention / Wait-List Control (Active Comparator); Early Intervention (Experimental)

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must meet all of the following criteria:
• Age ≥ 18 years.
• Diagnosis: Biopsy-confirmed invasive breast cancer.
• Treatment Plan: Scheduled to undergo breast cancer surgery, with or without neoadjuvant chemotherapy.
• 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.
• Residence: Resides in Nova Scotia and able to participate in a province-wide, digitally delivered program.
• 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.
• Language Ability: Able to read, speak, and understand English sufficiently to follow program content and complete study questionnaires.
• 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.

You may not qualify if:

• Participants will be excluded if any of the following apply:
• 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.
• 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.
• Participation Limitations: Unwillingness or inability to complete required questionnaires or engage with digitally delivered program components.

Sponsors & Collaborators

• Gabriela Ilie: lead
• Nova Scotia Health Authority: collaborator
• Dalhousie University: collaborator
• Queen Elizabeth II Health Sciences Centre: collaborator

Study Sites (1)

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Empowerment; Psychological Well-Being; Patient Participation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Social Behavior; Behavior; Personal Satisfaction; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior

Central Study Contacts

Gabriela Ilie, PhD

CONTACT

902-989-4114; Gabriela.Ilie@dal.ca

Cody MacDonald, MSc

CONTACT

902-237-6277; CodyMacDonald@dal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: February 6, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): March 15, 2028
• Study Completion (Estimated): March 15, 2029
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)