Empowerment Program for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
This trial is for women over 18 in Nova Scotia with newly diagnosed invasive breast cancer, who can safely do some physical activity and have access to the internet. They should be able to understand English and are willing to fill out questionnaires online during the study.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the Breast Cancer Patient Empowerment Program (BC-PEP) for 6 months, including daily emails with structured physical activity guidance, arm and shoulder rehabilitation exercises, mindfulness practices, and lifestyle education modules.
Follow-up
Participants are monitored for psychological distress, quality of life, and other health outcomes after the intervention.
What Are the Treatments Tested in This Trial?
Interventions
- Breast Cancer Patient Empowerment Program (BreastCancerPEP)
Trial Overview
The Breast Cancer Patient Empowerment Program (BreastCancerPEP) is being tested. It's a six-month home-based program delivered online, focusing on exercise, stress reduction, healthy habits, and social support. The goal is to see if it helps reduce psychological distress compared to standard care.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Gabriela Ilie
Lead Sponsor
Nova Scotia Health Authority
Collaborator
Dalhousie University
Collaborator
Queen Elizabeth II Health Sciences Centre
Collaborator
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.