Prostate Cancer - Patient Empowerment Program (PC-PEP)

Randomized Clinical Trial of an Early vs Late Patient Empowerment Program for Men Undergoing Curative Treatment for Prostate Cancer

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: PC-PEP

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Nova Scotia
    • Halifax, Nova Scotia, Canada
      • QEII Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Arm A - Early Intervention; For 180 days participants in this arm will be exposed to the intervention and 180 days afterwards they will be exposed to the standard of care.	Behavioral: PC-PEP; 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.
ACTIVE_COMPARATOR: Arm B - Late Intervention; For 180 days participants in this arm will be exposed to the standard of care and 180 days afterwards they will be exposed to the intervention.	Behavioral: PC-PEP; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mental Health	Kessler 10 - assessment of psychological distress pre (day 0) and post (6 months) intervention and end of study (12 months). Measured through on-line survey.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
General Health (Physical and Mental) Quality of Life	The Short Form (SF-12) Health Survey will be used to assess views about general health (physical and mental) quality of life. Change score will be calculated by taking the difference between measures taken at baseline (day 0) and post intervention (day 180).Assessment of these measures will also be completed at the end of the study (day 360). Assessed via on-line survey.	12 months
Functional, emotional and social well being	The Functional Assessment of Cancer Therapy-Prostate (FACT-P) will be used to measure psychosocial factors. Changes will be calculated by taking the difference between measures taken at baseline (day 0) and post intervention (day 180).Assessment of these measures will also be completed at the end of the study (day 360). Assessed via on-line survey.	12 month
Urinary, bowel, hormonal, & sexual function	The Expanded Prostate Index Composite (EPIC) (urinary, bowel, hormonal and sexual) and I-PSS (urinary) will be used to measure urinary function pre and post intervention. Change score will be calculated by taking the difference between measures taken at baseline (day 0) and post intervention (day 180). This will be assessed via on-line survey. Assessment of these measures will also be completed at the end of the study (day 360).	12 month
EEG (Brainwaves)	Electroencephalography (EEG) assessment of stress state will be measured using the Muse (IntraXon, Inc. Toronto, Ontario, Canada) neurofeedback device. Averages in relaxation brainwaves activity measurements (e.g. alpha, beta, delta, theta, and gamma) will be taken over listening to 10 minutes of relaxation music and instructions. The difference between scores at baseline (day 0) and post intervention (day 180) will be assessed. Assessment of these measures will also be completed at the end of the study (day 360). Assessment will be performed during study visits.	12 month
Heart rate variability	Heart rate variability (HRV) will be assessed through a HRV monitor produced by HeartMath institute. participants will be given home the device for biofeedback purposes with regards to practicing the meditation training received. The device produces scores of HRV and those at pre- (day 0) will be compared to scores at post intervention (day 180), and also at the end of the study (day 360). This will be assessed via on-line survey.	12 months
Relationship Satisfaction	Dyadic Assessment Scale will be used to assess relationship satisfaction at pre- (day 0) will be compared to scores at post intervention (day 180), and also at the end of the study (day 360).	12 months
Diet	Starting the conversation diet questionnaire will be used (developed by CHPDP). It will be assessed on-line via a survey (day 0, day 180 and day 360)	12 months
Health care utilization	This will be assessed online through two questions assessing number of visits to see a health care practitioner, and hospital admissions one year prior to the study and then during the year when the study was conducted.	12 months
Physical fitness: Six-minute walk test	Pre and post intervention assessment of physical fitness assessed to see how many meters the p[participant can walk during a timed six-minute walk test. Pre and Post scores will be taken at baseline (day 0 - pre) and post intervention (day 180 post). Assessment of these measures will also be completed at the end of the study (day 360) during study visits. Differences between the assessments will be assessed to see if the intervention had an effect.	12 months
Physical fitness: One-legged stance test	The length of time (in seconds) of static postural and balance control will be assessed at pre and post intervention, measured in minutes. Change score will be calculated by taking the difference between each of the pre and post measures taken at baseline (day 0) and post intervention (day 180). Assessment of these measures will also be completed at the end of the study (day 360) during study visits. Differences between the assessments will be assessed to see if the intervention had an effect.	12 months
Physical fitness: Timed sit-to-stand test	Pre and post intervention participants will be timed for 30 seconds to measure the amount of time they can go from sitting to standing in the allocated 30 seconds. The test will be used to test for lower limb strength. Change score will be calculated by taking the difference between each of the measures taken at baseline (day 0) and post intervention (day 180). Assessment of these measures will also be completed at the end of the study (day 360) during study visits.Differences between the assessments will be assessed to see if the intervention had an effect.	12 months
Physical fitness: Flexibility of shoulder and hamstring	Flexibility of shoulder and hamstring will be assessed recording the distance (in cm) rather than the degrees of the reach. Change score will be calculated by taking the difference between each of the measures taken at baseline (day 0) and post intervention (day 180). Assessment of these measures will also be completed at the end of the study (day 360) during study visits.Differences between the assessments will be assessed to see if the intervention had an effect.	12 months
Physical fitness: Grip strength	Pre and Post measurements of grip strength using a dynamometer will be used to test the strength of the arm and and hand forearm muscles. Change score will be calculated by taking the difference between each of the measures taken at baseline (day 0) and post intervention (day 180). Assessment of these measures will also be completed at the end of the study (day 360) during study visits.Differences between the assessments will be assessed to see if the intervention had an effect.	12 months
Height	The height of the individual will be measured in cm at the start of the program.	Day one of the study
Weight	The weight of the individual participants will be measured in kg using a manual scale, in kg, at pre and post intervention. Change score will be calculated by taking the difference between each of the measures taken at baseline (day 0) and post intervention (day 180). Assessment of these measures will also be completed at the end of the study (day 360) during study visits.Differences between the assessments will be assessed to see if the intervention had an effect.	12 months
BMI - body mass index	Body mass index will be calculated at pre and post intervention using the height and weight scores obtained. The BMI formula we will use is: Kg/m2 where kg is a person's weight in kilograms and m2 is their height in metres squared. Change score will be calculated by taking the difference between each of the measures taken at baseline (day 0) and post intervention (day 180). Assessment of these measures will also be completed at the end of the study (day 360) during study visits. Differences between the assessments will be assessed to see if the intervention had an effect.	12 months

Collaborators and Investigators

• Sponsor: Nova Scotia Health Authority
• Collaborators: Dalhousie University; Queen Elizabeth II Health Sciences Centre
• Investigators: Principal Investigator: Gabriela Ilie, PhD, Nova Scotia Health Authority; Principal Investigator: Rob Rutledge, MD, FRCPC, Nova Scotia Health Authority

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 18, 2019
• Primary Completion (ACTUAL): April 15, 2022
• Study Completion (ACTUAL): May 18, 2022

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: September 4, 2018
• First Posted (ACTUAL): September 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): July 12, 2022
• Last Update Submitted That Met QC Criteria: July 8, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Exercise; Mental Health; Prostate Cancer; Meditation; Radiation Therapy; Pelvic floor exercises; Stress reduction; Radical Prostatectomy; Urological Symptoms; Pre-Habilitation; Intimacy and Connection; Social connection
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: PCaPRO_Halifax_001; PCaPRO_Halifax_002 (OTHER: NSHA)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No