BreastCancerPEP: A Randomized Trial of a Six-Month Online Empowerment Program to Improve Mental and Physical Health in Women With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Proportion of participants with clinically significant psychological distress (Kessler Psychological Distress Scale-10 ≥20)
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Breast Cancer Patient Empowerment Program (BreastCancerPEP) (Behavioral)
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.
干预措施: Breast Cancer Patient Empowerment Program (BreastCancerPEP) (Behavioral)
结局指标
主要结局
Proportion of participants with clinically significant psychological distress (Kessler Psychological Distress Scale-10 ≥20)
时间窗: 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.
次要结局
- 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.)
- Change in self-efficacy (Self-Efficacy for Managing Chronic Disease 6-item Scale)(Baseline to 6 months; baseline to 12 months)
- Change in patient activation (Patient Activation Measure-13)(Baseline to 6 months; baseline to 12 months)
- Change in generalized anxiety symptoms (GAD-7)(Baseline to 6 months; baseline to 12 months)
- Change in cognitive function (PROMIS® Short Form v2.0 - Cognitive Function 8a)(Baseline to 6 months; baseline to 12 months)
- Change in upper-limb disability and symptoms (QuickDASH)(Baseline to 6 months; baseline to 12 months)
- Change in menopause symptoms (Menopause Quick 6)(Baseline to 6 months; baseline to 12 months)
- Change in social support (Medical Outcomes Study Social Support Survey)(Baseline to 6 months; baseline to 12 months)
- Change in body weight (self-reported kilograms)(Baseline to 6 months; baseline to 12 months)
- Change in diet quality (Rapid Eating Assessment for Participants - Shortened v2)(Baseline to 6 months; baseline to 12 months)
- Self-reported adherence to cancer treatment(Baseline to 6 months; baseline to 12 months)
- Clinically verified adherence to cancer treatment(Baseline to 6 months; baseline to 12 months)
- Number of hospitalizations (administrative data)(Baseline to 6 months; baseline to 12 months)
- Number of physician billing events (administrative data)(Baseline to 6 months; baseline to 12 months)
研究者
Gabriela Ilie
Associate Professor
Nova Scotia Health Authority