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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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. I

Первичные конечные точки

• Proportion of participants with clinically significant psychological distress (Kessler Psychological Distress Scale-10 ≥20) [Срок оценки: 6 months after randomization (Day 183 ± 2 days)]

Вторичные конечные точки (12)

• Change in psychological distress (Kessler Psychological Distress Scale-10 total score) [Срок оценки: Baseline to 6 months; baseline to 12 months]
• Change in health-related quality of life (SF-12v2 Physical and Mental Component Scores) [Срок оценки: Baseline to 6 months; baseline to 12 months]
• Change in health utility score (SF-6D) [Срок оценки: Baseline to 6 months; baseline to 12 months]
• Change in cancer-specific quality of life (EORTC QLQ-C30) [Срок оценки: Baseline to 6 months; Baseline to 12 months.]
• Change in breast cancer-specific quality of life (EORTC QLQ-BR23) [Срок оценки: Baseline to 6 months; Baseline to 12 months.]
• Change in self-efficacy (Self-Efficacy for Managing Chronic Disease 6-item Scale) [Срок оценки: Baseline to 6 months; baseline to 12 months]
• Change in patient activation (Patient Activation Measure-13) [Срок оценки: Baseline to 6 months; baseline to 12 months]
• Change in generalized anxiety symptoms (GAD-7) [Срок оценки: Baseline to 6 months; baseline to 12 months]
• Change in cognitive function (PROMIS® Short Form v2.0 - Cognitive Function 8a) [Срок оценки: Baseline to 6 months; baseline to 12 months]
• Change in upper-limb disability and symptoms (QuickDASH) [Срок оценки: Baseline to 6 months; baseline to 12 months]
• Change in menopause symptoms (Menopause Quick 6) [Срок оценки: Baseline to 6 months; baseline to 12 months]
• Change in social support (Medical Outcomes Study Social Support Survey) [Срок оценки: Baseline to 6 months; baseline to 12 months]

Критерии участия

Критерии включения

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.

Критерии исключения

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Канада · 1 центр

• Queen Elizabeth II Health Sciences Centre — Halifax

Идентификаторы

NCT: NCT07392424 · BreastCancerPEP-RCT-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗