Prostate Cancer Clinical Trial
— PC-PEPOfficial title:
PC-PEP Phase 4: Predictors of Mental Health in Men With Prostate Cancer Undergoing a Patient Empowerment Program
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.
Status | Recruiting |
Enrollment | 500 |
Est. completion date | October 1, 2025 |
Est. primary completion date | September 29, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Canada | QEII Health Sciences Centre | Halifax | Nova Scotia |
Canada | Saint John Regional Hospital | Saint John | New Brunswick |
Lead Sponsor | Collaborator |
---|---|
Nova Scotia Health Authority |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mental Health | Kessler 10 - assessment of psychological distress. Measured through on-line survey. | 6 - 24 months | |
Secondary | General Health (Physical and Mental) Quality of Life as assessed by the 12-item Short Form Health Survey (SF-12) | The scale has a score range of 0 to 100, with a higher score indicating a better outcome, and a score of 50 indicating the U.S. population average. | 6 - 24 months | |
Secondary | Disease Specific Health-Related Quality of Life as assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P) | A 39-item questionnaire. The scale has a total score range of 0-156 with a higher score indicating better quality of life. | 6 - 24 months | |
Secondary | Urinary, Bowel, Hormonal, and Sexual Function as assessed by the Expanded Prostate Cancer Index Composite (EPIC) | A 50-item questionnaire to evaluate patient function and bother after prostate cancer treatment. The scale has a score range of 0-100 with a higher score indicating a better outcome. | 6 - 24 months | |
Secondary | Urinary Bother as assessed by the International Prostate Symptom Score (IPSS) | A 7-item questionnaire. The scale has a score range of 0-35 with a higher score indicating more severe urinary bother. | 6 - 24 months | |
Secondary | Health Care Utilization | This will be assessed through the following survey questions: During the PAST 6 MONTHS, how many TIMES did you visit a doctor or health care provider for physical illness? (do not include visits while you were in the hospital for your Prostate Cancer treatment (e.g., radiation, surgery, etc)? During the PAST 6 MONTHS, how many TIMES did you visit a doctor or health care provider for a mental health issue? How many TIMES did you visit the emergency room in the PAST 6 MONTHS but were not admitted overnight? How many TIMES were you admitted to the hospital overnight in the PAST 6 MONTHS? |
6 - 24 months | |
Secondary | Relationship Satisfaction as assessed by the Dyadic Adjustment Scale (DAS) | DAS is a 32-item questionnaire that measures an individual's perceptions of their relationship with an intimate partner. The scale has a total score range of 1-151 with a higher score indicating better satisfaction. | 6 - 24 months | |
Secondary | Diet as assessed by the Starting the Conversation (STC) Questionnaire | STC is an 8-item simplified food frequency instrument designed for use in primary care and health-promotion settings. The instrument has a score range of 0-16 with a higher score indicating worse diet. | 6 - 24 months | |
Secondary | Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI) | PSQI included 19self-rated items that assess sleep quality and disturbances over a 1-month time interval. The scale has a score range of 0-21, with a higher score indicating worse sleep quality. | 6 - 24 months |
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