Prostate CancerPC-PEPNCT03660085
Prostate Cancer - Patient Empowerment Program
A study testing PC-PEP in people with Prostate Cancer, run by Nova Scotia Health Authority at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PC-PEP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteCanada
- Study dates
- 18 Dec 2019to 18 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- PC-PEP
- 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
- Medical subject headings
- Prostatic Neoplasms, Psychological Well-Being, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PC-PEPBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A - Early Intervention | Experimental | 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. Receives: Behavioral: PC-PEP |
| Arm B - Late Intervention | Active comparator | 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. Receives: Behavioral: PC-PEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Clinically Significant Psychological Distress (Kessler Psychological Distress Scale-10 ≥20)
Proportion of participants scoring ≥20 on the Kessler Psychological Distress Scale-10 (K10) at 6 months after randomization. The K10 is a validated 10-item measure of psychological distress with scores ranging from 10-50, where higher scores indicate worse distress.
Measured: From baseline until 6 month follow-up time-point.
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Height
The height of the individual will be measured in cm at the start of the program.
Measured: 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.
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2018
- Study start18 Dec 2019
- Primary completion15 Apr 2022
- Study completion18 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- 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 blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nova Scotia Health Authority
- Sponsor type
- University, hospital or other
- Collaborators
- Dalhousie University, Queen Elizabeth II Health Sciences Centre
- Responsible party
- Principal investigator, Gabriela Ilie, Nova Scotia Health Authority
- Investigators
- Gabriela Ilie, PhD, Principal investigator, Nova Scotia Health AuthorityRob Rutledge, MD, FRCPC, Principal investigator, Nova Scotia Health Authority
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660085
- Sponsor's protocol ID
- PCaPRO_Halifax_001
- Other IDs
- PCaPRO_Halifax_002
- Acronym
- PC-PEP
- Status last verified
- Mar 2026
- First submitted
- 29 Aug 2018
- Last updated
- 3 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Power B, Smith NK, Ilie G, Rendon RA, Mason R, Kokorovic A, MacDonald C, Patil N, Bowes D, Bailly G, Wilke D, Langley E, Rutledge R. Diet and Physical Activity as Mediators of Weight Loss in a Digital Prostate Cancer Survivorship Intervention for Men: Secondary Analysis of the PC-PEP Randomized Trial. Am J Mens Health. 2026 Jul-Aug;20(4):15579883261457532. doi: 10.1177/15579883261457532. Epub 2026 Aug 5.
PubMed 42552876Burgher C, Ilie G, Mason R, Rendon R, Kokorovic A, Bailly G, Patil N, Bowes D, Wilke D, MacDonald C, Tsirigotis M, Butler C, Bell D, Spooner J, Rutledge RDH. Assessing the Impact of the Prostate Cancer Patient Empowerment Program (PC-PEP) on Relationship Satisfaction, Quality of Life, and Support Group Participation: A Randomized Clinical Trial. Curr Oncol. 2024 Oct 21;31(10):6445-6474. doi: 10.3390/curroncol31100479.
PubMed 39451783
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial of an Early vs Late Patient Empowerment Program for Men Undergoing Curative Treatment for Prostate Cancer
- ClinicalTrials.gov ID
- NCT03660085
- Acronym / sponsor ID
- PC-PEP / PCaPRO_Halifax_001
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Radical Prostatectomy, Urological Symptoms, Radiation Therapy, Mental Health, Pre-Habilitation, Exercise, Pelvic floor exercises
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Nova Scotia Health AuthorityUniversity, hospital or other
- Collaborators
- Dalhousie University, Queen Elizabeth II Health Sciences Centre
- Study start
- 18 Dec 2019 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 18 May 2022 (actual)
- First posted
- 6 Sep 2018 (actual)
- Results
- Posted 3 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Arm A - Early Intervention | Experimental | Behavioral: PC-PEPFor 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. |
| Arm B - Late Intervention | Active comparator | Behavioral: PC-PEPFor 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PC-PEPThe 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. | Behavioural | Arm A - Early Intervention, Arm B - Late Intervention |
Primary outcome
Proportion of Participants With Clinically Significant Psychological Distress (Kessler Psychological Distress Scale-10 ≥20)
Time frame: From baseline until 6 month follow-up time-point.
Proportion of participants scoring ≥20 on the Kessler Psychological Distress Scale-10 (K10) at 6 months after randomization. The K10 is a validated 10-item measure of psychological distress with scores ranging from 10-50, where higher scores indicate worse distress.
16 secondary outcomes
General Health (Physical and Mental) Quality of Life
Time frame: 12 months
Functional, Emotional and Social Well Being
Time frame: 12 month
Urinary, Bowel, Hormonal, & Sexual Function
Time frame: 12 month
EEG (Brainwaves)
Time frame: 12 month
Heart Rate Variability
Time frame: 12 months
Relationship Satisfaction
Time frame: 12 months
Diet
Time frame: 12 months
Health Care Utilization
Time frame: 12 months
Physical Fitness: Six-minute Walk Test
Time frame: 12 months
Physical Fitness: One-legged Stance Test
Time frame: 12 months
Physical Fitness: Timed Sit-to-stand Test
Time frame: 12 months
Physical Fitness: Flexibility of Shoulder and Hamstring
Time frame: 12 months
Physical Fitness: Grip Strength
Time frame: 12 months
Height
Time frame: Day one of the study
Weight
Time frame: 12 months
BMI - Body Mass Index
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42552876Power B, Smith NK, Ilie G, Rendon RA, Mason R, Kokorovic A, MacDonald C, Patil N, Bowes D, Bailly G, Wilke D, Langley E, Rutledge R. Diet and Physical Activity as Mediators of Weight Loss in a Digital Prostate Cancer Survivorship Intervention for Men: Secondary Analysis of the PC-PEP Randomized Trial. Am J Mens Health. 2026 Jul-Aug;20(4):15579883261457532. doi: 10.1177/15579883261457532. Epub 2026 Aug 5.
- Derived from this study: PubMed 39451783Burgher C, Ilie G, Mason R, Rendon R, Kokorovic A, Bailly G, Patil N, Bowes D, Wilke D, MacDonald C, Tsirigotis M, Butler C, Bell D, Spooner J, Rutledge RDH. Assessing the Impact of the Prostate Cancer Patient Empowerment Program (PC-PEP) on Relationship Satisfaction, Quality of Life, and Support Group Participation: A Randomized Clinical Trial. Curr Oncol. 2024 Oct 21;31(10):6445-6474. doi: 10.3390/curroncol31100479.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriela Ilie, PhD principal investigator
Nova Scotia Health Authority
Rob Rutledge, MD, FRCPC principal investigator
Nova Scotia Health Authority
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PC-PEP in people with Prostate Cancer, run by Nova Scotia Health Authority at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With Clinically Significant Psychological Distress (Kessler Psychological Distress Scale-10 ≥20) (time frame: From baseline until 6 month follow-up time-point.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03660085, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2026.