Empowerment program for men with prostate cancer to improve mental health
PC-PEP Phase 4: Predictors of Mental Health in Men With Prostate Cancer Undergoing a Patient Empowerment Program
This study tests whether a special program that helps men with prostate cancer improve their mental health and quality of life works better than regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 2130 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Nova Scotia Health Authority Academic / other |
| Drugs / interventions | radiation |
| Locations | 16 sites (Ghent, East Flanders and 15 other locations) |
| Trial ID | NCT04895839 on ClinicalTrials.gov |
What this trial studies
This program aims to support men diagnosed with prostate cancer by implementing the Prostate Cancer Patient Empowerment Program (PC-PEP), which focuses on enhancing mental health and quality of life. The intervention includes education on life skills, physical activity, stress reduction, and social support, delivered through in-person and multimedia formats. The study will compare the outcomes of participants in the PC-PEP program against a control group receiving standard care, assessing their mental health and treatment-related side effects over a period of 24 months.
Who should consider this trial
Good fit: Ideal candidates are men over 18 years old with a history of prostate cancer who are safe to engage in physical activity and willing to participate in the program.
Not a fit: Patients deemed unfit to participate or those with advanced prostate cancer without physician approval may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly improve the mental health and overall quality of life for men undergoing treatment for prostate cancer.
How similar studies have performed: Other studies have shown success with similar empowerment and support programs for cancer patients, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>18 * History of a prostate cancer diagnosis * Safe to exercise and do strength training (participants who have recovered from a minor stroke or heart condition in the past will require approval from their Family Physician or Cardiologist to participate in the study. Participants with advanced prostate cancer will need approval from the Study Physician or their Urologist or Oncologist to participate) * Existing (or willingness to create) email account * Willingness to access and use daily email and/or text messages * Ability to follow website links to watch YouTube videos * Ability to understand and speak English * Ability to participate in low to moderate levels of physical activity * Ability and willingness to fill out an online survey at baseline, and 6, 12 and 24 months, and a weekly compliance survey for the six months of the program. * Deemed to have an expected survival greater than 2 years Exclusion Criteria: * Patients deemed unfit to participate in low level exercise eg. 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. * Unable to access the internet and lack of a computer or cellphone to receive emails required for study intervention, or unable to click on a link to successfully watch a YouTube video. * Men with a predicted survival less than 2 years.
Where this trial is running
Ghent, East Flanders and 15 other locations
- University Hospital Ghent — Ghent, East Flanders, Belgium (Not_yet_recruiting)
- Dianne and Irving Kipnes Urology Centre — Edmonton, Alberta, Canada (Recruiting)
- BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre) — Kelowna, British Columbia, Canada (Recruiting)
- Men's Health Clinic Manitoba — Winnipeg, Manitoba, Canada (Recruiting)
- Saint John Regional Hospital — Saint John, New Brunswick, Canada (Recruiting)
- Health Sciences Centre — St. John's, Newfoundland and Labrador, Canada (Recruiting)
- QEII Health Sciences Centre — Halifax, Nova Scotia, Canada (Recruiting)
- Mount Sinai Hospital — Toronto, Ontario, Canada (Recruiting)
- Whitby Health Centre - Dr. Ernest Chan Medicine Professional Corporation — Whitby, Ontario, Canada (Recruiting)
- Queen Elizabeth Hospital — Charlottetown, Prince Edward Island, Canada (Recruiting)
- Hôpital de l'Enfant-Jésus — Québec, Quebec, Canada (Recruiting)
- Saskatoon Health Authority — Saskatoon, Saskatchewan, Canada (Recruiting)
- Prostate Cancer Foundation of New Zealand — Auckland, New Zealand (Recruiting)
- Medisprof Cancer Center — Cluj-Napoca, Transylvania, Romania (Not_yet_recruiting)
- Sefako Makgatho Health University — Ga-Rankuwa, Gauteng, South Africa (Recruiting)
- Charlotte Maxeke Johannesburg Academic Hospital — Johannesburg, Gauteng, South Africa (Recruiting)
Study contacts
- Study coordinator: Gabriela Ilie, PhD
- Email: Gabriela.Ilie@dal.ca
- Phone: 902-989-4114
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.