RecruitingNot ApplicableNCT04895839

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


Sponsor

Gabriela Ilie

Enrollment

2,130 participants

Start Date

Sep 29, 2021

Study Type

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

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying what factors affect the mental health of men living with prostate cancer who join an online empowerment and exercise program. You may be eligible if... - You are a man over 18 with a prostate cancer diagnosis - You are physically cleared to do low to moderate exercise (men recovering from a minor stroke or heart issue may need doctor approval) - You have or are willing to create an email account and can access YouTube videos and online surveys - You can communicate in English - Your expected survival is greater than 2 years You may NOT be eligible if... - You have had a heart attack or stroke in the past year without doctor clearance to exercise - You cannot access the internet or use a computer or phone - Your expected survival is less than 2 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPatient Empowerment Program

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)

University Hospital Ghent

Ghent, East Flanders, Belgium

Dianne and Irving Kipnes Urology Centre

Edmonton, Alberta, Canada

BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)

Kelowna, British Columbia, Canada

Men's Health Clinic Manitoba

Winnipeg, Manitoba, Canada

Saint John Regional Hospital

Saint John, New Brunswick, Canada

Health Sciences Centre

St. John's, Newfoundland and Labrador, Canada

QEII Health Sciences Centre

Halifax, Nova Scotia, Canada

Mount Sinai Hospital

Toronto, Ontario, Canada

Whitby Health Centre - Dr. Ernest Chan Medicine Professional Corporation

Whitby, Ontario, Canada

Queen Elizabeth Hospital

Charlottetown, Prince Edward Island, Canada

Hôpital de l'Enfant-Jésus

Québec, Quebec, Canada

Saskatoon Health Authority

Saskatoon, Saskatchewan, Canada

Prostate Cancer Foundation of New Zealand

Auckland, New Zealand

Medisprof Cancer Center

Cluj-Napoca, Transylvania, Romania

Sefako Makgatho Health University

Ga-Rankuwa, Gauteng, South Africa

Charlotte Maxeke Johannesburg Academic Hospital

Johannesburg, Gauteng, South Africa

View Full Details on ClinicalTrials.gov

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NCT04895839


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