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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
Scientific title
PC-PEP Phase 4: Predictors of Mental Health in Men With Prostate Cancer Undergoing a Patient Empowerment Program
Secondary ID [1] 0 0
PC_PEP_Phase 4_Protocol
Universal Trial Number (UTN)
Trial acronym
PC-PEP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Prostate

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
BEHAVIORAL
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Mental Health
Timepoint [1] 0 0
6 - 24 months
Secondary outcome [1] 0 0
General Health (Physical and Mental) Quality of Life as assessed by the 12-item Short Form Health Survey (SF-12)
Timepoint [1] 0 0
6 - 24 months
Secondary outcome [2] 0 0
Disease Specific Health-Related Quality of Life as assessed by the Functional Assessment of Cancer Therapy-Prostate (FACT-P)
Timepoint [2] 0 0
6 - 24 months
Secondary outcome [3] 0 0
Urinary, Bowel, Hormonal, and Sexual Function as assessed by the Expanded Prostate Cancer Index Composite (EPIC)
Timepoint [3] 0 0
6 - 24 months
Secondary outcome [4] 0 0
Urinary Bother as assessed by the International Prostate Symptom Score (IPSS)
Timepoint [4] 0 0
6 - 24 months
Secondary outcome [5] 0 0
Health Care Utilization
Timepoint [5] 0 0
6 - 24 months
Secondary outcome [6] 0 0
Relationship Satisfaction as assessed by the Dyadic Adjustment Scale (DAS)
Timepoint [6] 0 0
6 - 24 months
Secondary outcome [7] 0 0
Diet as assessed by the Starting the Conversation (STC) Questionnaire
Timepoint [7] 0 0
6 - 24 months
Secondary outcome [8] 0 0
Sleep Quality as assessed by the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [8] 0 0
6 - 24 months

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
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
Yes
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.

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
29/09/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/10/2025
Actual
Sample size
Target
500
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Alberta
Country [2] 0 0
Canada
State/province [2] 0 0
British Columbia
Country [3] 0 0
Canada
State/province [3] 0 0
New Brunswick
Country [4] 0 0
Canada
State/province [4] 0 0
Nova Scotia
Country [5] 0 0
Canada
State/province [5] 0 0
Ontario
Country [6] 0 0
Canada
State/province [6] 0 0
Saskatchewan
Country [7] 0 0
New Zealand
State/province [7] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
Nova Scotia Health Authority
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT04895839
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Gabriela Ilie, PhD
Address 0 0
Country 0 0
Phone 0 0
902-989-4114
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04895839