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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04895839
Registration number
NCT04895839
Ethics application status
Date submitted
13/05/2021
Date registered
20/05/2021
Date last updated
19/09/2024
Titles & IDs
Public title
Predictors of Mental Health in Men With Prostate Cancer Undergoing a Patient Empowerment Program
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Scientific title
PC-PEP Phase 4: Predictors of Mental Health in Men With Prostate Cancer Undergoing a Patient Empowerment Program
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Secondary ID [1]
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PC_PEP_Phase 4_Protocol
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Universal Trial Number (UTN)
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Trial acronym
PC-PEP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer
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Condition category
Condition code
Cancer
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Prostate
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
BEHAVIORAL - Patient Empowerment Program
Experimental: Intervention Arm -
BEHAVIORAL: Patient Empowerment Program
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.
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Intervention code [1]
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BEHAVIORAL
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Mental Health
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Assessment method [1]
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Kessler 10 - assessment of psychological distress. Measured through on-line survey.
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Timepoint [1]
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6 - 24 months
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Secondary outcome [1]
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General Health (Physical and Mental) Quality of Life as assessed by the 12-item Short Form Health Survey (SF-12)
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Assessment method [1]
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The scale has a score range of 0 to 100, with a higher score indicating a better outcome, and a score of 50 indicating the U.S. population average.
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Timepoint [1]
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6 - 24 months
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Secondary outcome [2]
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Disease Specific Health-Related Quality of Life as assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P)
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Assessment method [2]
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A 39-item questionnaire. The scale has a total score range of 0-156 with a higher score indicating better quality of life.
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Timepoint [2]
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6 - 24 months
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Secondary outcome [3]
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Urinary, Bowel, Hormonal, and Sexual Function as assessed by the Expanded Prostate Cancer Index Composite (EPIC)
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Assessment method [3]
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A 50-item questionnaire to evaluate patient function and bother after prostate cancer treatment. The scale has a score range of 0-100 with a higher score indicating a better outcome.
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Timepoint [3]
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6 - 24 months
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Secondary outcome [4]
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Urinary Bother as assessed by the International Prostate Symptom Score (IPSS)
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Assessment method [4]
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A 7-item questionnaire. The scale has a score range of 0-35 with a higher score indicating more severe urinary bother.
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Timepoint [4]
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6 - 24 months
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Secondary outcome [5]
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Health Care Utilization
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Assessment method [5]
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This will be assessed through the following survey questions: 1. During the PAST 6 MONTHS, how many TIMES did you visit a doctor or health care provider for physical illness? (do not include visits while you were in the hospital for your Prostate Cancer treatment (e.g., radiation, surgery, etc)? 2. During the PAST 6 MONTHS, how many TIMES did you visit a doctor or health care provider for a mental health issue? 3. How many TIMES did you visit the emergency room in the PAST 6 MONTHS but were not admitted overnight? 4. How many TIMES were you admitted to the hospital overnight in the PAST 6 MONTHS?
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Timepoint [5]
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6 - 24 months
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Secondary outcome [6]
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Relationship Satisfaction as assessed by the Dyadic Adjustment Scale (DAS)
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Assessment method [6]
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DAS is a 32-item questionnaire that measures an individual's perceptions of their relationship with an intimate partner. The scale has a total score range of 1-151 with a higher score indicating better satisfaction.
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Timepoint [6]
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6 - 24 months
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Secondary outcome [7]
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Diet as assessed by the Starting the Conversation (STC) Questionnaire
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Assessment method [7]
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STC is an 8-item simplified food frequency instrument designed for use in primary care and health-promotion settings. The instrument has a score range of 0-16 with a higher score indicating worse diet.
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Timepoint [7]
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6 - 24 months
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Secondary outcome [8]
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Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
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Assessment method [8]
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PSQI included 19self-rated items that assess sleep quality and disturbances over a 1-month time interval. The scale has a score range of 0-21, with a higher score indicating worse sleep quality.
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Timepoint [8]
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6 - 24 months
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key 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.
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Study design
Purpose of the study
Other
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Not applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
29/09/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/10/2025
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Actual
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Sample size
Target
500
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Alberta
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Country [2]
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Canada
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State/province [2]
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British Columbia
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Country [3]
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Canada
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State/province [3]
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New Brunswick
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Country [4]
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Canada
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State/province [4]
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Nova Scotia
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Country [5]
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Canada
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State/province [5]
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Ontario
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Country [6]
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Canada
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State/province [6]
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Saskatchewan
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Country [7]
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New Zealand
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State/province [7]
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Auckland
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Funding & Sponsors
Primary sponsor type
Other
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Name
Nova Scotia Health Authority
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT04895839
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Gabriela Ilie, PhD
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Address
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Country
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Phone
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902-989-4114
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04895839
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