Empowerment Program for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a six-month online program can reduce stress and improve the well-being of women undergoing treatment for newly diagnosed invasive breast cancer. The program, called the Breast Cancer Patient Empowerment Program (BreastCancerPEP), provides daily guidance on exercise, stress reduction, healthy habits, and social support. Participants will be randomly assigned to start the program immediately or after six months. Women living in Nova Scotia with internet access, who are scheduled for breast cancer surgery and can safely exercise, may be eligible to participate. As an unphased trial, this study offers participants a unique opportunity to contribute to innovative research that could enhance support for women with breast cancer.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It focuses on a home-based program for breast cancer patients, so it's best to discuss your medications with the trial coordinators or your doctor.
What prior data suggests that this program is safe for breast cancer patients?
Research shows that the Breast Cancer Patient Empowerment Program (Breast Cancer PEP) is manageable for participants. Studies on similar programs, such as CancerPEP, have found they help reduce stress in cancer patients, suggesting general safety. Participants often report improved emotional well-being, indicating a positive experience with minimal risks.
The Breast Cancer PEP includes activities like guided exercises, relaxation techniques, and lifestyle education, which typically don't cause serious side effects. No major reports of negative effects have emerged from these programs, which aim to enhance both mental and physical health.
Overall, evidence supports the program's safety. It seeks to improve quality of life without introducing new health risks.12345Why are researchers excited about this trial?
Researchers are excited about the Breast Cancer Patient Empowerment Program (BreastCancerPEP) because it offers a holistic approach that integrates physical, mental, and social health components, which isn't typical in standard breast cancer care. Unlike usual treatments that may focus predominantly on medical interventions like surgery, chemotherapy, or radiation, this program emphasizes daily physical activity, mindfulness, and lifestyle education, all delivered digitally right to the participant's home. The inclusion of peer-support check-ins and monthly videoconference sessions adds a unique social dimension, potentially improving the overall well-being and quality of life for breast cancer patients.
What evidence suggests that the Breast Cancer Patient Empowerment Program is effective for reducing psychological distress in breast cancer patients?
Research shows that the Breast Cancer Patient Empowerment Program, available to participants in this trial, can greatly reduce stress in cancer patients. Studies have found that similar programs significantly improve mental health and overall well-being. These programs lower stress and enhance the quality of life for those undergoing cancer treatment. They also boost confidence and provide helpful support through easy-to-use online resources. In related studies, about 86% of participants rated their experience as very positive, demonstrating the program's effectiveness in empowering patients.12467
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
Citations
The Cancer Patient Empowerment Program - PMC
A randomized controlled trial (RCT) of PC-PEP showed substantial reductions in psychological distress and improved oncological outcomes [7,8,9,10]. However, the ...
BreastCancerPEP: A Six-Month Online Empowerment ...
This study is evaluating a six-month, home-based Patient Empowerment Program (Breast Cancer PEP) for women receiving treatment for newly ...
The Cancer Patient Empowerment Program
Conclusions: CancerPEP significantly reduces psychological distress in cancer patients, with consistent improvements noted across various cancer ...
Effect on patient empowerment through the EPEP program.
Of 21 respondents, n=18 (86%) rated their experience as very positive; agreed or strongly agreed that the program gave them the confidence to ...
The impact of an empowering Internet-based Breast ...
The results of studies suggest a positive relationship between Internet or computer-based patient education programmes and knowledge level [35], [36], [37], [38] ...
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ctv.veeva.com
ctv.veeva.com/study/breastcancerpep-a-six-month-online-empowerment-program-to-improve-mental-and-physical-health-in-womA Six-Month Online Empowerment Program to Improve Mental ...
This study is evaluating a six-month, home-based Patient Empowerment Program (Breast Cancer PEP) for women receiving treatment for newly ...
Strategies to Promote Empowerment Status of Breast ...
This study is aimed at determining the empowerment status of breast cancer patients referred to the Shahid Motahari Breast Cancer Clinic in Iran, Shiraz,
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