Predictors of Mental Health in Men With Prostate Cancer Undergoing a Patient Empowerment Program
PC-PEP Phase 4: Predictors of Mental Health in Men With Prostate Cancer Undergoing a Patient Empowerment Program
Gabriela Ilie
2,130 participants
Sep 29, 2021
INTERVENTIONAL
Conditions
Summary
Each year over 20,000 men are diagnosed with prostate cancer in Canada with the majority undergoing some form of treatment option. Radical prostatectomy and/or radiation therapy are common procedures that are effective in the treatment of prostate cancer. However, they typically incur both short- and long-term side effects (e.g. urinary incontinence, sexual dysfunction, reduced physical function, etc) that can negatively impact one's quality of life. This program of research aims to address the most critical needs of PC survivors: the development and evaluation of interventions to address the quality of life impact of PC. This study will test the Prostate Cancer Patient Empowerment Program (PC-PEP) in 400 men, a comprehensive intervention aimed at educating and teaching the men life skills/habits in order to improve their mental health issues, fitness levels and overall quality of life, and to decrease treatment related side effects. The program also aims to improve the overall health of the participants in the long term.
Eligibility
Inclusion Criteria10
- 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 Criteria3
- 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.
Interventions
The 6 months "at home" program focuses on aerobic and strength training, pelvic floor muscle exercises, meditation, social connection, and overall healthy lifestyle practices supported with daily text message/email reminders. The aerobic (5 times/week) and strength (2 times/week) program will comprise of a single 30-minute session daily and will be individualized to each participant. Pelvic floor muscle training will include three, 10-minute sessions and mediation for 10 minutes daily. Intimacy and Connection component of PC-PEP consists of engaging in at least one form of intimacy practice prescribed, per day. Social connection will be fostered by pairing participants up with peers from the study. To encourage program compliance, study participants will receive 3 daily reminders to do their pelvic floor muscle exercises per day plus an additional motivational email daily containing helpful tips.
Locations(16)
View Full Details on ClinicalTrials.gov
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NCT04895839