Clinical trial NCT04895839: Predictors of Mental Health in Men With Prostate Cancer Undergoing a Patient Empowerment Program
Official title: PC-PEP Phase 4: Predictors of Mental Health in Men With Prostate Cancer Undergoing a Patient Empowerment Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Prostate Cancer
Keywords: mental health
quality of life
empowerment program
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: In a survey study of almost 400 survivors of prostate cancer (PC), the investigators 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, the investigators 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. The investigators 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. Technology is used 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. It is predicted that PC-PEP will improve mental health (primary outcome) and other quality of life outcomes of patients compared with 'usual care'.

A randomized, wait-list controlled clinical trial for men newly diagnosed with PC is currently underway. This next phase will open the program to more men and expand the inclusion criteria. Participants in the PC-PEP will receive the intervention for six months. Introducing a comprehensive empowerment program from day one 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 that treatment related side effects will place on our health care system. Given that the study has the endorsement of patients, clinicians and administrators at Nova Scotia Health, if proven successful it will have the evidence base needed to change the current standard of care.

Eligibility criteria: 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.

Primary outcomes:
measure: Mental Health
timeFrame: 6 - 24 months
Secondary outcomes:
measure: General Health (Physical and Mental) Quality of Life as assessed by the 12-item Short Form Health Survey (SF-12)
timeFrame: 6 - 24 months
measure: Disease Specific Health-Related Quality of Life as assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P)
timeFrame: 6 - 24 months
measure: Urinary, Bowel, Hormonal, and Sexual Function as assessed by the Expanded Prostate Cancer Index Composite (EPIC)
timeFrame: 6 - 24 months
measure: Urinary Bother as assessed by the International Prostate Symptom Score (IPSS)
timeFrame: 6 - 24 months
measure: Health Care Utilization
timeFrame: 6 - 24 months
measure: Relationship Satisfaction as assessed by the Dyadic Adjustment Scale (DAS)
timeFrame: 6 - 24 months
measure: Diet as assessed by the Starting the Conversation (STC) Questionnaire
timeFrame: 6 - 24 months
measure: Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 6 - 24 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Dianne and Irving Kipnes Urology Centre
state: Alberta
city: Kelowna
country: Canada
facility: BC Cancer - Kelowna (Sindi Ahluwalia Hawkins Centre)
state: British Columbia
city: Saint John
country: Canada
facility: Saint John Regional Hospital
state: New Brunswick
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Saskatoon
country: Canada
facility: Saskatoon Health Authority
state: Saskatchewan
city: Auckland
country: New Zealand
facility: Prostate Cancer Foundation of New Zealand
Study officials:
References: