Cancer Patient Empowerment Program for Cancer

(CancerPEP Trial)

Overseen By Gabriela Ilie, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Nova Scotia Health Authority

Disqualifiers: Recent myocardial infarction, Recent stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program designed to help cancer patients and survivors improve their quality of life. It aims to boost both physical and mental health through activities like exercise, stress reduction, and better eating habits. Participants receive daily emails with tips and exercises over six months and may use a heart rate variability (HRV) monitor. This trial suits those who have had a cancer diagnosis and feel ready to engage in low to moderate physical activities. Participants should be comfortable using email and watching YouTube videos. As an unphased trial, this study offers a unique opportunity for participants to enhance their well-being through personalized support and practical strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the study team or your doctor.

What prior data suggests that this program is safe for cancer patients?

Research shows that the Cancer Patient Empowerment Program (CancerPEP) is generally easy for participants to handle. Studies have examined the safety of this program, which includes activities like exercise, yoga, and stress reduction. Results indicate that these activities are safe for most people, even those with minor strokes or heart issues, although these participants should get their doctor's approval first. No serious side effects have been reported from the program. Overall, the program appears safe for improving both mental and physical health in cancer patients and survivors. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Cancer Patient Empowerment Program (CancerPEP) because it aims to enhance cancer treatment by empowering patients through innovative techniques. Unlike traditional treatments that focus solely on medication or surgery, CancerPEP incorporates an approach involving heart rate variability (HRV) monitoring, which could provide real-time feedback on a patient's stress and recovery levels. This personalized feedback could help patients manage their treatment and recovery more effectively, potentially improving their overall quality of life. By exploring these new methods, researchers hope to find out how patient empowerment can play a role in cancer care.

What evidence suggests that the Cancer Patient Empowerment Program is effective for improving quality of life in cancer patients?

Research shows that the Cancer Patient Empowerment Program (CancerPEP) reduces stress and anxiety in cancer patients. Studies have consistently found improvements in mental health for patients with various types of cancer. In this trial, participants will divide into two groups: one will receive the intervention with an HRV monitor, while the other will receive it without an HRV monitor. The program includes activities like exercise, yoga, and stress reduction techniques, which enhance physical and mental well-being. Participants in previous programs experienced positive changes, suggesting that CancerPEP can improve the quality of life for cancer patients and survivors. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for cancer patients and survivors over 18 who can access daily emails, watch YouTube videos, understand English, and are safe to exercise. They should expect to live more than a year and be able to complete surveys throughout the program. Approval from physicians may be required for those with certain health conditions.

Inclusion Criteria

I am older than 18 years.

I can follow web links and watch YouTube videos.

Participants with advanced cancer (including cancer spread to bones) will need approval from the Study Physician or their Oncologist to participate

Exclusion Criteria

Patients deemed unfit to participate in low to moderate level exercise e.g., including but not limited to a myocardial infarction or stroke within the last year, without approval from their Family Physician or Cardiologist that they are safe to exercise

Those with a predicted survival less than 1 year, or not expected to be able to participate in the program for six months

Unable to access the internet and lack of a computer or smartphone to receive emails required for study intervention, or unable to click on a link to successfully watch a YouTube video

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive daily email communications over 6 months that encourage strength and aerobic exercise, yoga, stress reduction techniques, dietary improvements, and more

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

6-24 months

What Are the Treatments Tested in This Trial?

Interventions

• CancerPEP

Trial Overview The Cancer Patient Empowerment Program (CancerPEP) is being tested. It's a six-month online program that includes strength training, yoga, stress reduction techniques, dietary advice through daily emails aimed at improving life quality and health in cancer patients.

How Is the Trial Designed?

Group I: Intervention without HRV monitor Experimental Treatment 1 Intervention

Group II: Intervention with HRV monitor Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Nova Scotia Health Authority

Lead Sponsor

Trials

302

Recruited

95,300+

Dalhousie University

Collaborator

Trials

177

Recruited

402,000+

Citations

1. cancerpep.com cancerpep.com/research/

Research - CancerPEP Patient summary: In this report, we examined the effectiveness of a program (Prostate Cancer Patient Empowerment Program: PC-PEP) developed with patients' ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11475673/

The Cancer Patient Empowerment Program Conclusions: CancerPEP significantly reduces psychological distress in cancer patients, with consistent improvements noted across various cancer types and ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39409993/

The Cancer Patient Empowerment Program Conclusions: CancerPEP significantly reduces psychological distress in cancer patients, with consistent improvements noted across various cancer ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT05508412

Cancer Patient Empowerment Program: Phase 2 ... The program includes daily email communications over 6 months that encourage strength and aerobic exercise, yoga, stress reduction techniques, dietary ...

5. researchgate.net researchgate.net/publication/395064803_Evaluating_the_cost-effectiveness_of_the_Prostate_Cancer_Patient_Empowerment_Program_A_comprehensive_health_economic_analysis_from_a_randomized_controlled_trial

Evaluating the cost-effectiveness of the Prostate Cancer ... Introduction: The aim of this study was to evaluate the cost-effectiveness of the Prostate Cancer Patient Empowerment Program (PC-PEP), ...

6. cancerpep.org cancerpep.org/

CancerPEP – Patient Education and Empowerment Programs ... Cancer PEP (Cancer Patient Empowerment Program) is a comprehensive daily home-based 6-month Empowerment Program offered by an Oncologist and a Psychology ...

7. researchgate.net researchgate.net/publication/384578787_The_Cancer_Patient_Empowerment_Program_A_Comprehensive_Approach_to_Reducing_Psychological_Distress_in_Cancer_Survivors_with_Insights_from_a_Mixed-Model_Analysis_Including_Implications_for_Breast_Cance

(PDF) The Cancer Patient Empowerment Program This study aimed to evaluate the feasibility, accrual and attrition rates, safety, and effectiveness of the CancerPEP intervention, with and ...