Recruiting

Observational Study

Sponsor:

Gabriela Ilie

Code:

NCT04895839

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

Interventions

Patient Empowerment Program

Study Details

Brief 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.

Conditions

Prostate Cancer

Study ID

NCT04895839

Start date

Sep 29, 2021

Status verified date

Mar, 2026

Completion date

Oct 1, 2031

Anticipated

Primary completion date

Apr 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

2130 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Intervention Arm

Interventions

Patient 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.

Primary outcome measure

  • Mental Health [ Time Frame: 6 - 24 months ]

Central Contacts and Locations

Central contacts

Gabriela Ilie, PhD

902-989-4114Gabriela.Ilie@dal.ca

Rob Rutledge, MD, FRCPC

902-473-6185Rob.Rutledge@nshealth.ca

Locations

Dianne and Irving Kipnes Urology Centre

Recruiting

Edmonton, Alberta, Canada, T6G 1Z1

Contacts

Howard Evans, MD

780-423-6843howarde@ualberta.ca

Principal Investigator:

Howard Evans, MD

BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)

Recruiting

Kelowna, British Columbia, Canada, V1Y 5L3

Contacts

Susan Ellard, MD

SEllard@bccancer.bc.ca

Men's Health Clinic Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3K 1M3

Contacts

Jasmir Nayak, MD

(204) 221-4476jnayak@sbgh.mb.ca

Saint John Regional Hospital

Recruiting

Saint John, New Brunswick, Canada, E2L 4L4

Contacts

Robert Thompson, MD

Robertd.thompson@horizonnb.ca

Health Sciences Centre

Recruiting

St. John's, Newfoundland and Labrador, Canada, A1B 3V6

Contacts

John Thoms, MD

(709) 777-2440john.thoms@easternhealth.ca

QEII Health Sciences Centre

Recruiting

Halifax, Nova Scotia, Canada, B3H 2Y9

Contacts

Gabriela Ilie, PhD

Gabriela.Ilie@dal.ca

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G 1X5

Contacts

Christopher Wallis, MD

Christopher.Wallis@sinaihealth.ca

Whitby Health Centre - Dr. Ernest Chan Medicine Professional Corporation

Recruiting

Whitby, Ontario, Canada, L1P 0P9

Contacts

Ernest Chan, MD

(905) 721-3278echan@lh.ca

Queen Elizabeth Hospital

Recruiting

Charlottetown, Prince Edward Island, Canada, C1A 8T5

Contacts

Larry Pan, MD

(902) 894-2951lmpan@ihis.org

Hôpital de l'Enfant-Jésus

Recruiting

Québec, Quebec, Canada, G1J 1Z4

Contacts

François Bachand, MD

(819) 821-8000Francois.Bachand.med@ssss.gouv.qc.ca

Saskatoon Health Authority

Recruiting

Saskatoon, Saskatchewan, Canada, S7M 2W2

Contacts

Kunal Jana, MD

Kunal.Jana@saskhealthauthority.ca

More Information

Sponsor

Gabriela Ilie

Last update posted

Mar 18, 2026

Last verified

Mar, 2026

Keywords

  • mental health
  • quality of life
  • empowerment program

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Gabriela Ilie on 2026-03-18.