Clinical trial NCT03660085: Prostate Cancer - Patient Empowerment Program
Official title: Randomized Clinical Trial of an Early vs Late Patient Empowerment Program for Men Undergoing Curative Treatment for Prostate Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
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
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
Collaborators: name: Dalhousie University
name: Queen Elizabeth II Health Sciences Centre
First posted: 2018-09-06
Enrollment: 140
Sex: MALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
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
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 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.

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

Primary outcomes:
measure: Mental Health
timeFrame: 12 months
Secondary outcomes:
measure: General Health (Physical and Mental) Quality of Life
timeFrame: 12 months
measure: Functional, emotional and social well being
timeFrame: 12 month
measure: Urinary, bowel, hormonal, & sexual function
timeFrame: 12 month
measure: EEG (Brainwaves)
timeFrame: 12 month
measure: Heart rate variability
timeFrame: 12 months
measure: Relationship Satisfaction
timeFrame: 12 months
measure: Diet
timeFrame: 12 months
measure: Health care utilization
timeFrame: 12 months
measure: Physical fitness: Six-minute walk test
timeFrame: 12 months
measure: Physical fitness: One-legged stance test
timeFrame: 12 months
measure: Physical fitness: Timed sit-to-stand test
timeFrame: 12 months
measure: Physical fitness: Flexibility of shoulder and hamstring
timeFrame: 12 months
measure: Physical fitness: Grip strength
timeFrame: 12 months
measure: Height
timeFrame: Day one of the study
measure: Weight
timeFrame: 12 months
measure: BMI - body mass index
timeFrame: 12 months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Gabriela Ilie, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nova Scotia Health Authority
name: Rob Rutledge, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: