Prostate Cancer - Patient Empowerment Program

Sponsor
Nova Scotia Health Authority
Study ID
NCT03660085
Status
Completed

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • PC-PEP — BEHAVIORAL
    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.

Study Details

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 study aims to educate and teach pre- (as opposed to most common post-) habilitation - preventive life habits aimed to empower men and address many of the issues faced by men undergoing radical prostatectomy or other active forms of prostate cancer treatments. The investigators hypothesize that daily text and email reminders, in addition to connecting men with other men undergoing similar challenges, will improve participant adherence to the pre-habilitation program. Secondary objectives will assess change in mental health, physical fitness, urological symptoms, state of relaxation, and quality of life parameters before and after the program.

Key Dates

Start date
Dec 18, 2019
Status verified
Mar 2026
Primary completion
Apr 15, 2022
Completion
May 18, 2022

Study Design

Enrollment
140 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE

Arms

  • Experimental: Arm A - Early Intervention
    For 180 days participants in this arm will be exposed to the intervention and 180 days afterwards they will be exposed to the standard of care.
  • Active Comparator: Arm B - Late Intervention
    For 180 days participants in this arm will be exposed to the standard of care and 180 days afterwards they will be exposed to the intervention.

Primary Outcome Measure

Proportion of Participants With Clinically Significant Psychological Distress (Kessler Psychological Distress Scale-10 ≥20) [ Time Frame: From baseline until 6 month follow-up time-point. ]

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