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Trial registered on ANZCTR


Registration number
ACTRN12621000477820
Ethics application status
Approved
Date submitted
2/03/2021
Date registered
21/04/2021
Date last updated
21/04/2021
Date data sharing statement initially provided
21/04/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Does a multimodal pre-habilitation intervention give better functional and quality of life outcomes than usual care in men choosing radical prostatectomy for localised prostate cancer?
Scientific title
Does a multimodal pre-habilitation intervention give better functional and quality of life outcomes than usual care in men choosing radical prostatectomy for localised prostate cancer? A Pilot Randomised Control Trial (RCT)
Secondary ID [1] 300443 0
None
Universal Trial Number (UTN)
U1111-1265-4975
Trial acronym
Prostate Cancer Prehabilitation Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 316106 0
Condition category
Condition code
Cancer 314395 314395 0 0
Prostate

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
20 patients (18 years and over) with newly diagnosed localised prostate cancer, opting for radical prostatectomy (and their partner/spouse), will be randomly allocated to the pre-habilitation multimodal supportive care intervention, which will comprise five main components:

(1) Informational Materials
Participants will be provided with a custom-made evidence based self-management booklet that will include: how to self-care; managing side-effects of radical prostatectomy; nutrition and exercise; relationships and sexual well-being; healthy lifestyle approaches; and community-based support resources. Once off written booklet.

(2) Pelvic Floor Muscle Training (PFMT)
Participants will be provided with a pelvic floor exercise program tailored to the pathophysiology of post prostatectomy incontinence. Education will include: anatomy; how to correctly contract the pelvic floor muscles without using accessory muscles. The Prostate Cancer Specialist Nurse will assess the correctness of their contraction using a mirror and palpation as biofeedback. Men will be taught how to functionally contract the pelvic floor before any changes in abdominal pressure to condition the pelvic floor to their adapted role post-surgery. Once mastered, the PFMT will be incorporated into the physical exercise programme. Once off session and re-visited at each visit with the specialist nurse session.

(3) Evidence-Based Self-Management Seminar
The self-management seminar will include: introduction to radical prostatectomy and side-effects; self-managing physical side-effects; education on good bladder and bowel habits; emotions and mental changes; body image, sexual dysfunction and relationships; Mediterranean diet and lifestyle advice; exercise; finance and benefits; relaxation and stress management; sign-posting to community based services; and an open question session with a specialist nurse. One session for 120-minute session.

(4) Physical Exercise Programme
Participants will be provided a physical exercise programme, which will be tailored to individual exercise abilities and existing co-morbidities. In keeping with “one size does not fit all approach” exercise programmes will include: circuit class-based activities, walking and home exercises. Frequency of physical exercise programme session will be at the time of recruitment, one week prior to surgery, six- and 12-weeks post-surgery. The progression of increase in exercise will be informed on individual physical assessment with the exercise physiologist in cancer care.

(5) Sexual Pre-habilitation
The man and his partner/spouse (where applicable) will meet with his responsible clinician to discuss realistic goals and expectations for the recovery of sexual function and plan an individualised pre-habilitation plan prior to radical prostatectomy. In line with anecdotal evidence participants will use sildenafil or tadalafil tablets (50mg and 10mg respectively) and/or vacuum therapy at night for 7-10 days prior to radical prostatectomy (unless there are medical contraindications to PDE5i administration) and men will be encouraged to maintain a normal sexual life before their operation. Once off session and re-visited at each visit with the specialist nurse session
Intervention code [1] 316735 0
Lifestyle
Comparator / control treatment
20 patients (18 years and older) with newly diagnosed localised prostate cancer, opting for radical prostatectomy (and their partner/spouse), will be randomly allocated to the control group consisting of standard care currently available at their clinical site. Current standard care includes provision of oral and written information from the operating surgeon about the procedure, along with the contact details of the specialist nurse should they require any further information, advice, or support. Although patients in the control group will not receive the intervention, they will be reminded as per standard practice at the participating hospital sites to contact clinicians responsible for their care whenever they wish to discuss any concerns/symptoms they might have.
Control group
Active

Outcomes
Primary outcome [1] 322747 0
Supportive Care Needs Survey (SCNS 36)
Timepoint [1] 322747 0
12 weeks -post surgery
Secondary outcome [1] 379549 0
6 Minute Walk Test
Timepoint [1] 379549 0
2 weeks prior to surgery and up to 12 weeks post-surgery
Secondary outcome [2] 379550 0
Expanded Prostate Cancer Index Composite (prostate cancer specific health-related quality of life)
Timepoint [2] 379550 0
Baseline, 6 weeks post-surgery and 12 weeks post-surgery
Secondary outcome [3] 379551 0
Mental Adjustment to Cancer Scale (coping)
Timepoint [3] 379551 0
Baseline, 6 weeks post-surgery and 12 weeks post-surgery
Secondary outcome [4] 379552 0
Self-Efficacy Scale
Timepoint [4] 379552 0
Baseline, 6 weeks post-surgery and 12 weeks post-surgery
Secondary outcome [5] 379553 0
Hospital Anxiety and Depression Scale
Timepoint [5] 379553 0
Baseline, 6 weeks post-surgery and 12 weeks post-surgery
Secondary outcome [6] 379554 0
Sense of Coherence Scale
Timepoint [6] 379554 0
Baseline, 6 weeks post-surgery and 12 weeks post-surgery
Secondary outcome [7] 379555 0
Measuring Dyadic Adjustment Scale
Timepoint [7] 379555 0
Baseline, 6 weeks post-surgery and 12 weeks post-surgery
Secondary outcome [8] 379556 0
Subjective Global Assessment Form
Timepoint [8] 379556 0
Baseline, 6 weeks post-surgery and 12 weeks post-surgery
Secondary outcome [9] 379557 0
Assessment of Quality of Life (AQoL)
Timepoint [9] 379557 0
Baseline, 6 weeks post-surgery and 12 weeks post-surgery
Secondary outcome [10] 379558 0
Preliminary cost-estimates: Data on the cost-estimates of intervention and standard care will be collected via several sources, including from patients, who will be asked to keep records of the cost of their treatment and care. Case note reviews will require access to medical records to determine relevant information, such as: cost due to change in medication, hospitalisation, onwards referrals for supportive care, hospital admissions, cost of medications (including those to optimise symptom control and pre-habilitation), outpatient appointments and out-of-hours care.
Timepoint [10] 379558 0
12 weeks - post surgery
Secondary outcome [11] 392225 0
Qualitative Interviews: Semi-structured interviews with 12 patients (6 in each arm) and their partner/spouse will be conducted. The interviews will be purposive sampling to capture maximum variation in experiences of care delivery in both study arms. The interviews will be conducted by a trained interviewer following a brief script designed for this study adopting broad open-ended questions. All interviews will be recorded and transcribed verbatim.
Timepoint [11] 392225 0
Baseline (pre-randomisation) and 12 weeks post-surgery
Secondary outcome [12] 392226 0
Qualitative Interviews: Interviews will be conducted with multidisciplinary healthcare professionals involved in delivering prostate cancer treatments and care (maximum of n=5 interviews) to explore perceptions of the barriers and facilitators to delivering pre-habilitation in standard care delivery at the end of the study.
Timepoint [12] 392226 0
End of study (12 weeks post-surgery)
Secondary outcome [13] 394273 0
30 second sit to stand test
Timepoint [13] 394273 0
2 weeks prior to surgery and up to 12 weeks post-surgery
Secondary outcome [14] 394274 0
blood pressure will be assessed using the SphygmoCor device (SphygmoCoR; At-Cor Medical Pty Ltd., Sydney, Australia).
Timepoint [14] 394274 0
2 weeks prior to surgery and up to 12 weeks post-surgery
Secondary outcome [15] 394311 0
pulse wave velocity will be assessed using the SphygmoCor device (SphygmoCoR; At-Cor Medical Pty Ltd., Sydney, Australia).
Timepoint [15] 394311 0
2 weeks prior to surgery and up to 12 weeks post-surgery

Eligibility
Key inclusion criteria
I. Age (18 years and older), patients (and, if applicable, their partner/spouse) newly diagnosed with localised PCa
II. confirmed by pathological and radiological diagnosis of prostate cancer
III. choosing radical prostatectomy
IV. self-assessed written and verbal English proficiency
V. able to provide written informed consent.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
I. Salvage radical prostatectomy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to either the intervention or control using block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size for this study (n=40) falls within the range of sample size recommendations for pilot studies of this nature. The aim is not hypothesis testing, the power level is therefore not a valid consideration for sample size.

(1) Qualitative Data:
The software analysis package QSR NVivo will be used to organise the data. The interviews will be analysed using framework analysis, which includes 5 key stages: familiarisation of the data; identifying a thematic framework; indexing themes; charting; mapping and interpretation. Audio recordings will be stored and destroyed securely after transcription. Deidentified transcripts will be used for analysis and destroyed 15 years after the end of the study. For reliability and validity of the themed categories, two researchers will code the qualitative data separately and then cross-check reaching an overall agreement. A third researcher will be consulted in areas of disagreement.

(2) Quantitative Data:
This study will be reported according to CONSORT guidelines. All feasibility outcomes will be reported narratively using descriptive statistics. Basic exploratory statistical analysis of indicative findings will be undertaken between the two groups. Baseline participant characteristics will be assessed as this is a pilot study. Data will be examined for quality and missing data. Intention to treat analysis will be managed using imputation of last observation carried forward. Outcomes data will be examined using a mixed model regression using group as the factor, and controlling for age, and baseline variables that are different between groups, in SPSS or STATA. Internal reliability of the standardised measures will be evaluated using Cronbach’s alpha statistic.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/05/2021
Actual
Date of last participant enrolment
Anticipated
26/07/2021
Actual
Date of last data collection
Anticipated
22/11/2021
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 18771 0
The Canberra Hospital - Garran
Recruitment hospital [2] 18772 0
National Capital Private Hospital - Garran
Recruitment postcode(s) [1] 33218 0
2605 - Garran

Funding & Sponsors
Funding source category [1] 304859 0
Charities/Societies/Foundations
Name [1] 304859 0
Prostate Cancer Foundation of Australia
Country [1] 304859 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
11 Kirinari St, Bruce ACT 2617,
Country
Australia
Secondary sponsor category [1] 305198 0
None
Name [1] 305198 0
Address [1] 305198 0
Country [1] 305198 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307922 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 307922 0
PO Box 11 Woden, ACT 2606
Ethics committee country [1] 307922 0
Australia
Date submitted for ethics approval [1] 307922 0
05/02/2020
Approval date [1] 307922 0
15/05/2020
Ethics approval number [1] 307922 0
2020/ETH00168

Summary
Brief summary
The purpose of this study is to test the implementation of a model of supportive care involving multidisciplinary pre-habilitation interventions for men affected by prostate cancer choosing radical prostatectomy (and if applicable, their partner/spouse). This study aims to improve couples' psychological adjustment and supportive self-management prior to radical cancer surgery.

Who is it for?
Men (18 years and over) with newly diagnosed localised prostate cancer opting for radical prostatectomy (and, if applicable, their partner/spouse).

Study details:
Participants in this study will be randomly allocated into one of two groups. One group will receive standard care currently available at their clinical site (provision of oral and written information and the contact details of a prostate cancer specialist nurse for additional support if required). The other group will undergo the pre-habilitation multimodal model of supportive care, which involves: informational materials, pelvic floor muscle training, an evidence based self-management seminar, tailored exercise programme and tailored sexual well-being information.

It is anticipated that the outcomes of this study will drive forward service improvements, produce information to help patients and their families and help clinical teams choose the most appropriate model of supportive care.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99830 0
Prof Catherine Paterson
Address 99830 0
University of Canberra
Building 10 Kirinari Street
Bruce, ACT 2616
Country 99830 0
Australia
Phone 99830 0
+61262068419
Fax 99830 0
Email 99830 0
catherine.paterson@canberra.edu.au
Contact person for public queries
Name 99831 0
Prof Catherine Paterson
Address 99831 0
University of Canberra
Building 10 Kirinari Street
Bruce, ACT 2616
Country 99831 0
Australia
Phone 99831 0
+61262068419
Fax 99831 0
Email 99831 0
catherine.paterson@canberra.edu.au
Contact person for scientific queries
Name 99832 0
Prof Catherine Paterson
Address 99832 0
University of Canberra
Building 10 Kirinari Street
Bruce, ACT 2616
Country 99832 0
Australia
Phone 99832 0
+61262068419
Fax 99832 0
Email 99832 0
catherine.paterson@canberra.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-identified individual participant data of published results only.
When will data be available (start and end dates)?
Data will be available on publication, to those who request it, for 5 years after publication.
Available to whom?
Available on reasonable request.
Available for what types of analyses?
Data will be available to researches only to achieve the aims in the approved proposal.
How or where can data be obtained?
Data will be available only to achieve the aims in the approved proposal by emailing the principal investigator catherine.paterson@canberra.edu.au


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.