Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001909213
Ethics application status
Approved
Date submitted
19/11/2018
Date registered
23/11/2018
Date last updated
23/11/2018
Date data sharing statement initially provided
23/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of Codesigning a Prehabilitation Program (Co-PreP) for patients with prostate cancer
Scientific title
Evaluating the feasibility of a Co-designed Prehabilitation Program (Co-PreP) for patients with prostate cancer
Secondary ID [1] 296564 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Co-PreP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer patients 310348 0
Condition category
Condition code
Cancer 309077 309077 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Co-PreP is a structured weekly outpatient group program, consisting of two components: 1) an hour of group exercise and 2) an hour of group education. For the initial session, participants are expected to attend both components of the program but will only be required to attend the one hour group exercise program for subsequent sessions. Participants will also be given the option to attend the education program for subsequent sessions if they feel that it will be of benefit. Participants who are flagged for radical prostatectomy or have a pre-existing continence issue will also be offered a half hour face to face pelvic floor and baseline continence assessment with an experienced continence physiotherapist

This program will be completed in the outpatient setting of Sunshine hospital

Education session
The one hour education session will be delivered in a group setting by the prostate cancer nurse specialist and continence physiotherapist. Utilising powerpoint presentations and models, the health professionals will educate patients on topics, as listed below:
- What is prostate cancer and biopsy results
- Treatment expectations including catheter care and symptom management
- Post treatment recovery and fatigue management
- Continence and pelvic health
- Physical and mental wellbeing
- Diet including how to prevent constipation
The presentations will take approximately 40 minutes, leaving 20 minutes for group discussions and questions and answer session. Further to these topics, an additional resource table will be set up to allow patients to collect brochures and gather further information on topics.

Group exercise session
The one hour group exercise training component will require participants to complete aerobic (walking and cycling) and strength (upper and lower limbs) training at a moderate to high intensity. Exercises will be progressed accordingly so as to ensure that participants are exercising at a level between 13 to 15 on the rate of perceived exertion (RPE) scale

All sessions will be supervised by a registered physiotherapist who has expertise in delivering exercise programs for people with prostate cancer.

Pelvic floor muscle training will also be incorporated as part of the group exercise session. In addition, participants will be advised to complete a minimum of two further exercise sessions in their home environment and will be provided with an exercise booklet and diary to encourage continuity of exercise outside of the program
Participants will continue to attend these weekly sessions until commencement of treatment. Duration of the program will vary between 2 weeks and 4 months.
Intervention code [1] 312868 0
Rehabilitation
Comparator / control treatment
No Control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308047 0
To evaluate the feasibility of implementing Co-PreP for patients with prostate cancer.
The rate of attendance and completion of Co-PreP will be collected via an electronic patient database (IPM) to ascertain the feasibility of the program
A participant will be considered to have completed Co-PreP if they have attended at least two group sessions. Co-PreP will be deemed feasible if a minimum of 70% of referred patients completed Co-PreP
Timepoint [1] 308047 0
Data to be collected at completion of the prehabilitation program.
Secondary outcome [1] 353816 0
To identify barriers to participation in Co-PreP.
If the patient declines to attend all of the group sessions verbal permission will then be sought over the phone for the project team to collect reasons for not attending Co-PreP.
Timepoint [1] 353816 0
To be collected prior to prostate cancer treatment
Secondary outcome [2] 353817 0
To ascertain if Co-PreP improves patient outcomes post completion of treatment.
Supportive Care Screening Distress Thermometer questionnaire will be used to assess cancer-specific distress,
Timepoint [2] 353817 0
Outcome will be collected prior to commencement of Co-PreP, post completion of Co-PreP and at three months post completion of prostate cancer treatment
Secondary outcome [3] 354215 0
To ascertain if Co-PreP improves patient outcomes International Consultation of Incontinence Modular- Urinary Incontinence Short Form (ICIQ-UISF) will be used to assess incontinence
Timepoint [3] 354215 0
This will be assessed prior to prehabilitation comencement and at 3 months post cancer treatment
Secondary outcome [4] 354216 0
To ascertain if Co-PreP improves patient outcomes. Sexual Health Inventory for Man (SHIM) will be completed to assess sexual dysfunction
Timepoint [4] 354216 0
To be assessed prior to commencement of prehabilitation and 3 months post completeion of cancer treatment
Secondary outcome [5] 354223 0
To ascertain if Co-PreP improves patient outcomes.
Patient will be invited to complete a patient satisfaction survey to ascertain the level of satisfaction with the program and if the program has assisted in helping patients feel prepared for their upcoming treatment. Completed surveys will be collected by a member of the project team that have not been involved in the conducting of the Co-PreP program so as to provide an opportunity for participants to provide honest feedback.
Satisfaction survey was specifically designed for this study.
Timepoint [5] 354223 0
Patient satisfaction survey to be completed at the end of the prehabilitation program

Eligibility
Key inclusion criteria
Prostate cancer patients receiving treatment at either Western Health or Peter MacCallum Sunshine Radiotherapy Centre. Treatment modalities may include radiotherapy, brachy therapy, radical prostatectomy, chemotherapy and hormone replacement therapies.

Physically able to participate in an outpatient group exercise program as determined by their ability to ambulate independently with or without a gait aid.

Cognitively able to comprehend information disseminated during the education session.
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who are flagged for active surveillance for their prostate cancer.
Patients who have pre-existing comorbidities hindering their ability to participate in an outpatient group exercise program: for example: unstable angina, stroke, severe musculoskeletal pain.
Prostate cancer patients who are in the terminal phase of their illness, as deemed by the treating specialist(s).
Prostate cancer patients who have pre-existing cognitive impairments or psychiatric history that will hinder their ability to participate.
Patients who have a waiting time of less than 2 weeks before commencement of treatment.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/11/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12377 0
Western Hospital - Footscray - Footscray
Recruitment hospital [2] 12379 0
Sunshine Hospital - St Albans
Recruitment hospital [3] 12380 0
Williamstown Hospital - Williamstown
Recruitment hospital [4] 12381 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 24642 0
3011 - Footscray
Recruitment postcode(s) [2] 24644 0
3021 - St Albans
Recruitment postcode(s) [3] 24645 0
3016 - Williamstown
Recruitment postcode(s) [4] 24646 0
3000 - Melbourne

Funding & Sponsors
Funding source category [1] 301142 0
Government body
Name [1] 301142 0
Western & Central Melbourne Integrated Cancer Service (WCMICS)
Country [1] 301142 0
Australia
Primary sponsor type
Hospital
Name
Western Health
Address
176 Furlong Rd St Albans, Victoria 3021
Country
Australia
Secondary sponsor category [1] 300762 0
Hospital
Name [1] 300762 0
Peter MacCallum Cancer Centre - Sunshine Radiatiotherapy Centre
Address [1] 300762 0
176 Furlong Road St Albans VIC 3021.Australia
Country [1] 300762 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301892 0
PETER MACCALLUM CANCER CENTRE HUMAN RESEARCH ETHICS COMMITTEE [EC00235]
Ethics committee address [1] 301892 0
Ethics committee country [1] 301892 0
Australia
Date submitted for ethics approval [1] 301892 0
07/09/2018
Approval date [1] 301892 0
19/10/2018
Ethics approval number [1] 301892 0
HREC/45967/PMCC-2018

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88454 0
Dr Clarice Youci Tang
Address 88454 0
Sunshine Hospital - Western Health
176 Furlong Road St Albans Melbourne Victoria Australia 3021
Country 88454 0
Australia
Phone 88454 0
+61 0411 868 030
Fax 88454 0
Email 88454 0
Clarice.Tang@wh.org.au
Contact person for public queries
Name 88455 0
Alesha Sayner
Address 88455 0
Sunshine Hospital - Western Health
176 Furlong Road St Albans Melbourne Victoria Australia 3021
Country 88455 0
Australia
Phone 88455 0
+61 03 8345 1355
Fax 88455 0
Email 88455 0
alesha.sayner@wh.org.au
Contact person for scientific queries
Name 88456 0
Clarice Youci Tang
Address 88456 0
Sunshine Hospital - Western Health
176 Furlong Road St Albans Melbourne Victoria Australia 3021
Country 88456 0
Australia
Phone 88456 0
+61 0411 868 030
Fax 88456 0
Email 88456 0
Clarice.Tang@wh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We will be providing patient data as a group and not individually due to confidentiality


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.