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NCT07392424

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

Sponsor: Gabriela Ilie

View on ClinicalTrials.gov

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.

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

Key Details

Gender

FEMALE

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2026-03-15

Completion Date

2029-03-15

Last Updated

2026-02-06

Healthy Volunteers

Conditions

Breast Cancer

Interventions

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.

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.

Locations (1)

Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada