N/A N=140 Randomized Single-blind Supportive Care

Prostate Cancer - Patient Empowerment Program

Prostate Cancer

Bottom Line

View on ClinicalTrials.gov: NCT03660085 ↗

Enrolled (actual)

140

Serious AEs

0.0%

Results posted

Apr 2026

Primary outcome: Primary: Proportion of Participants With Clinically Significant Psychological Distress (Kessler Psychological Distress Scale-10 ≥20) — 9; 14; 57; 48 Participants — p=0.031

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: PC-PEP (Behavioral)
Age: Adult, Older Adult · 18+ yrs
Sex: Male
Sponsor: Nova Scotia Health Authority
Primary completion: Apr 2022

Outcome Measures

Outcome	Result	p-value
PRIMARY Proportion of Participants With Clinically Significant Psychological Distress (Kessler Psychological Distress Scale-10 ≥20)	9; 14; 57; 48	0.031 sig
SECONDARY General Health (Physical and Mental) Quality of Life	—	—
SECONDARY Functional, Emotional and Social Well Being	—	—
SECONDARY Urinary, Bowel, Hormonal, & Sexual Function	—	—
SECONDARY EEG (Brainwaves)	—	—
SECONDARY Heart Rate Variability	—	—
SECONDARY Relationship Satisfaction	—	—
SECONDARY Diet	—	—
SECONDARY Health Care Utilization	—	—
SECONDARY Physical Fitness: Six-minute Walk Test	—	—
SECONDARY Physical Fitness: One-legged Stance Test	—	—
SECONDARY Physical Fitness: Timed Sit-to-stand Test	—	—
SECONDARY Physical Fitness: Flexibility of Shoulder and Hamstring	—	—
SECONDARY Physical Fitness: Grip Strength	—	—
SECONDARY Height	—	—
SECONDARY Weight	—	—
SECONDARY BMI - Body Mass Index	—	—

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 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.

Eligibility Criteria

Inclusion Criteria

History of prostate cancer diagnosis
Non-metastatic stage at start of study
Approval from screening physician to participant in study
Existing (or willingness to create) email account
Ability to access and use daily email +/- text messages
Ability to understand and speak English language
Ability to participate in low to moderate levels of physical activity
Scheduled for a Radical Prostatectomy (RP) or curative intent Radiotherapy (RT)(external bean or bratty) or adjuvant or salvage RT post RP. Patient on Hormone therapy are eligible if they are scheduled to undergo RP or RT.
If deemed necessary by study physician, approval from family physician or oncologist to participate in the study

Exclusion Criteria

Unable to travel to Halifax for study visits (3 in total)
Unable to access the internet and lack of a computer/cellphone to receive emails required for study intervention
Patients being treated with Hormone therapy only
Patients on Active Surveillance
Patients deemed unfit to participate in low level exercise

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03660085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.