Prostate Cancer - Patient Empowerment Program
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

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.
    

Detailed description: 
      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 radiotherapy. 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.
    

Intervention name(s): PC-PEP
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants receive one of two (or more) alternative interventions during the initial phase of the study and receive the other intervention during the second phase of the study
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Prostate Cancer; Radical Prostatectomy; Urological Symptoms; Radiation Therapy; Mental Health; Pre-Habilitation; Exercise; Pelvic floor exercises; Intimacy and Connection; Social connection; Meditation; Stress reduction