Official Title
Randomized Clinical Trial of an Early vs Late Patient Empowerment Program for Men Undergoing Curative Treatment for Prostate Cancer
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.
Trial Description
Primary Outcome:
Secondary Outcome:
- General Health (Physical and Mental) Quality of Life
- Functional, emotional and social well being
- Urinary, bowel, hormonal, & sexual function
- EEG (Brainwaves)
- Heart rate variability
- Relationship Satisfaction
- Diet
- Health care utilization
- Physical fitness: Six-minute walk test
- Physical fitness: One-legged stance test
- Physical fitness: Timed sit-to-stand test
- Physical fitness: Flexibility of shoulder and hamstring
- Physical fitness: Grip strength
- Height
- Weight
- BMI - body mass index
In a survey study of almost 400 survivors of prostate cancer (PC), we found that 17% of them
suffered currently from mental health issues, and most were not on medication to address this
issue. Compounding issues included urinary and sexual disfunction, poor attendance to support
groups, intimacy, problems sleeping and other health problems. To address these many issues
directly, with the endorsement of physicians and patients attending our regional PC
integrative care conference (April 2018) and expanding on pre-habitation (pre-surgery)
science, we created a Patient Empowerment Program (PEP) to be delivered from day one of
diagnosis, to educate and teach the men and partners life skills/habits which are aimed to
improve their fitness levels and quality of life, and to decrease treatment related side
effects. This program is in line with the Auditor General of Nova Scotia's 2017 report
endorsing the use of bottom-up evidence-based interventions, created from actively engaging
patients in development and process. We aim to trial PC-PEP for men undergoing curative
treatment for PC versus a control group receiving standard care. The PC-PEP program includes
in-person and multimedia informational, physical activity, pelvic floor, stress reduction,
and relationship/connection training. The men are connected with other participants to
increase social support and maximize compliance. We use technology to deliver daily alerts to
patients to remind them to engage in the program. A PC-PEP feasibility study of 30 men, over
28 days, showed that the program is feasible, leads to positive outcomes in patients and is
highly (9.79/10) endorsed by patients. We propose a Randomized Clinical Trial assessing
PC-PEP over 6 months from day one of diagnosis. We predict that PC-PEP will improve mental
health (primary outcome) and other quality of life outcomes of patients compared with 'usual
care'.
This is a randomized, wait-list controlled clinical trial for men newly diagnosed with PC and
undergoing curative surgery and/or radiation therapy. The PEP group will receive the intervention
for six months (early intervention) while the wait-list group will start the same program at
the end of this intervention (late intervention; for six months). Outcomes will be assessed
at baseline, six and twelve months. The primary outcome is mental health measured by the
Kessler Psychological Distress Scale (K10 questionnaire) at the end of the intervention
period. Multiple secondary endpoints include urinary, bowel and sexual function, fitness
levels, fatigue, sleep, intimacy/sexuality concerns, relationship satisfaction, social
support and surrogates of medical costs (e.g., number of visits to medical professionals).
Introducing a comprehensive empowerment program from day 1 of diagnosis may mitigate against
the high levels of mental distress short and long-term suffered by hundreds of Nova Scotian
men undergoing curative PC treatment every year, and the burden treatment related side
effects will place on our health care system. Given that the study has the endorsement of
patients, clinicians and administrators at NSHA, if proven successful it will have the
evidence base needed to change the current standard of care.
View this trial on ClinicalTrials.gov
