Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000874516
Ethics application status
Approved
Date submitted
22/02/2024
Date registered
17/07/2024
Date last updated
17/07/2024
Date data sharing statement initially provided
17/07/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
PRO-Health – A prostate cancer specific healthy eating and exercise program
Scientific title
PRO-Health – A remotely-delivered prostate cancer specific personalised healthy eating and exercise program to manage side effects from androgen deprivation therapy: A feasibility, acceptability and preliminary efficacy pilot trial
Secondary ID [1] 311589 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prostate cancer 332976 0
Androgen deprivation therapy 332977 0
Condition category
Condition code
Cancer 329688 329688 0 0
Prostate
Diet and Nutrition 329689 329689 0 0
Other diet and nutrition disorders
Physical Medicine / Rehabilitation 329690 329690 0 0
Other physical medicine / rehabilitation
Musculoskeletal 329691 329691 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a 12-week pilot randomised controlled trial to evaluate the feasibility, acceptability and preliminary efficacy of PRO-Health: a multifactorial online platform that provides individualised educational material on (i) prostate cancer and treatment side effects and (ii) nutrition and exercise behaviour change multimedia to support remotely delivered nutrition and exercise video-consultation from a dietitian and exercise physiologist. The program will specifically target men with prostate cancer treated with androgen deprivation therapy.

Participants will be randomised (1:1 ratio) to the usual care group or the PRO-Health intervention after baseline testing. Those receiving the PRO-Health intervention will receive the following combined nutrition and exercise intervention in parallel.

Nutrition
Participants will receive 4x individualised nutrition consultations with an accredited practising dietitian delivered via video-consultation using Zoom Video Communications ™. Consultations will be scheduled at Baseline, Week 2, 4 and 8. The initial consultation will be 60-minutes with review consultations being 45-mins. At each consultation the dietitian will follow a standardised medical nutrition therapy protocol where the initial assessment will:

•Assess current clinical symptoms, treatment side effects, weight history, and social history.
•Review dietary intake using a standardised 24-hr dietary recall.
•Create a personalised dietary plan to meet dietary targets: (i) protein (1.2-1.5g/kg/day); (ii) calculate energy requirements with restrictions of 500-1000 kJ/day; (iii) general healthy eating for cardiovascular health. Recommendations are derived from the American Society of Clinical Oncology (ASCO) Exercise, Nutrition and Weight management during cancer treatment guidelines and the American Cancer Society (ASC) nutrition and physical activity guidelines for cancer survivors.
•Following the Coventry, Aberdeen & London - Refined (CALO-RE) behaviour change taxonomy framework PRO-Health includes nutrition education material, a personalised dietary plan, and recipes to support dietary behaviour change.
•Review consultations will follow the same structure but also evaluate adherence (24-hr recall, session attendance) to dietary goals and progressively change dietary intake where needed.

Exercise
The exercise component of this intervention will consist of 4x individualised exercise consultation with an exercise physiologist using Zoom Video Communications ™. Consultations will be scheduled at Baseline, Week 1 (optional check-in), 2, 4 and 8. The initial consultation will be 90-minutes with review consultations being 60-mins. Exercise equipment (resistance band and yoga mat) will be couriered to participants in advance. The consultation structure will follow:
•Assess and evaluate any contraindications to exercise (including past medical history) and environment for safe exercise.
•Explanation of exercise technique and form with demonstrations of exercise performed by the participants.
•The exercise prescription will contain 3 sessions/week of combined (1) aerobic exercise (moderate intensity: 50-70% HRmax) lasting 30-mins walking/cycling (including a warm-up and cool-down) and (2) resistance-band training lasting 40-mins at a moderate intensity aiming for 2-3 sets of 8-12 repetitions of 6-8 exercises targeting major muscle groups (i.e., banded chest press, bent over row, squat, lunge).
•Following the CALO-RE behaviour change taxonomy framework PRO-Health includes exercise education material and videos of the exercises with written description. To monitor adherence to the exercise program after each exercise session participants will be asked to rate their rating of perceived exertion, level of pain, enjoyment, and completion of the exercise session through PRO-Health.
•Review consultations will follow the same structure but also modify the exercise prescript where needed.

After 12-weeks participants in the intervention group will be asked to participate in a semi-structured interview. Guided by the Consolidated Framework for Implementation Research, the interviews will explore participants experiences of the study procedure, intervention components, education material, self-efficacy and future alterations required for PRO-Health. The first 12 participants that opt-in to the interview will be interviewed. Interviews will be conducted by PI Baguley.
Intervention code [1] 328045 0
Prevention
Intervention code [2] 328046 0
Lifestyle
Comparator / control treatment
The control group will follow usual care from their health care provider, this may include any medical appointment or medically needed allied health support. Participants allocated to the usual care group will receive general healthy eating and physical activity handouts from the Prostate Cancer Foundation of Australia at baseline. After 12-weeks, the usual care group will have access to the PRO-Health program and will receive a once-off consultation from either an accredited practising dietitian or accredited exercise physiologist following the same structure described above.
Control group
Active

Outcomes
Primary outcome [1] 337474 0
Feasibility outcomes include (1) uptake.
Timepoint [1] 337474 0
At completion of the 12-week intervention.
Primary outcome [2] 337475 0
(2) retention.
Timepoint [2] 337475 0
At completion of the 12-week intervention.
Primary outcome [3] 337476 0
(3) consent rate.
Timepoint [3] 337476 0
At completion of the 12-week intervention.
Secondary outcome [1] 432020 0
Feasibility of intervention components include (1) attendance.
Timepoint [1] 432020 0
At completion of the 12-week intervention.
Secondary outcome [2] 432022 0
(2) Adherence to the nutrition and exercise prescription (composite outcome).
Timepoint [2] 432022 0
At completion of the 12-week intervention.
Secondary outcome [3] 432023 0
(3) Usage of the PRO-Health platform
Timepoint [3] 432023 0
At completion of the 12-week intervention.
Secondary outcome [4] 432024 0
(4) Safety of the intervention
Timepoint [4] 432024 0
At completion of the 12-weeks intervention.
Secondary outcome [5] 432025 0
(5) Intervention satisfaction
Timepoint [5] 432025 0
At 12-weeks after commencing the study.
Secondary outcome [6] 432026 0
(6) Intervention acceptability
Timepoint [6] 432026 0
At 12-weeks after commencing the study.
Secondary outcome [7] 432027 0
Body composition
Timepoint [7] 432027 0
At baseline and 12-weeks after commencing the study.
Secondary outcome [8] 432028 0
Waist circumference
Timepoint [8] 432028 0
At baseline and 12-weeks after commencing the study.
Secondary outcome [9] 432029 0
Calf circumference
Timepoint [9] 432029 0
At baseline and 12-weeks after commencing the study.
Secondary outcome [10] 432030 0
Lower limb muscle strength/function assessed via 30 second sit to stand test
Timepoint [10] 432030 0
At baseline and 12-weeks after commencing the study.
Secondary outcome [11] 432031 0
Functional Assessment of Cancer Therapy – General (FACT-G)
Timepoint [11] 432031 0
At baseline and 12-weeks after commencing the study.
Secondary outcome [12] 432032 0
Modified body image scale (BIS)
Timepoint [12] 432032 0
At baseline and 12-weeks after commencing the study.
Secondary outcome [13] 432033 0
Physical activity and sedentary behaviour assessed via Accelerometers (composite outcome).
Timepoint [13] 432033 0
At baseline and 12-weeks after commencing the study.
Secondary outcome [14] 432034 0
Dietary intake
Timepoint [14] 432034 0
At baseline and 12-weeks after commencing the study.

Eligibility
Key inclusion criteria
1. Age 18+ years
2. A diagnosis of prostate cancer and treated with Androgen Deprivation Therapy for >3 months
3. Body mass index <40 kg/m2
4. Not currently meeting the dietary and exercise guidelines for cancer survivors or under the care of a nutrition or exercise health professional
5. Not taking any supplements other than a single multivitamin; unless stated for medical purpose (i.e., vitamin D supplement for low bone mineral density)
6. Free of any musculoskeletal, neurological, respiratory, metabolic or cardiovascular conditions that may prevent safe completion of the exercise demands of the study.
7. Access to a smart device with stable internet and video capabilities
8. English is your primary language
Minimum age
18 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Body mass index <24.9 kg/m2 (healthy weight or underweight), weight >200 kg
2. Bone metastases
3. Any electronic medical implant such as a pacemaker

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will completed after baseline testing by an external research to the study team. After this, the research team and participant will know the the group they have been randomised to.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Online simple randomisation sequence generator.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Process evaluation measures will include rate of participant uptake, retention and completion. Feasibility will include the rate of attendance, adherence and usage of the program.

For demographic analysis descriptive analysis will be used to summarise the data (i.e., mean, SD, range, IQR). Counts and percentages will be used to summarise data on recruitment, retention, website usage data, adverse events (tabulated by severity grade) and other feasibility and acceptability outcomes. Intention to treat linear mixed models will be used to determine changes secondary outcome measures between the intervention and usual care group at baseline and 12-weeks. Models will include group, time, and group x time as fixed factors, and a random intercept term for each participant in the study to account for the correlation between repeated observations on an individual. All models also adjusted for baseline values by inclusion as a covariate. Statistical significance will be two-tailed and accepted at the P=0.05 level. For FACT-F and FACT-P questionnaires, a 3 point increase in mean score will be classified as clinical important change.

Interviews will be transcribed, cleaned, and exported to NVIVO for thematic analysis. Line by line coding will be completed to identify key concepts from the data. Themes will not be predefined but led from the coding of participant responses.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/08/2024
Actual
Date of last participant enrolment
Anticipated
31/10/2025
Actual
Date of last data collection
Anticipated
30/01/2026
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 315896 0
Government body
Name [1] 315896 0
Victorian Cancer Agency
Country [1] 315896 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Country
Australia
Secondary sponsor category [1] 318047 0
None
Name [1] 318047 0
Address [1] 318047 0
Country [1] 318047 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314741 0
Deakin University Human Research Ethics Committee (DUHREC)
Ethics committee address [1] 314741 0
Ethics committee country [1] 314741 0
Australia
Date submitted for ethics approval [1] 314741 0
13/02/2024
Approval date [1] 314741 0
14/05/2024
Ethics approval number [1] 314741 0
2024-038

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

Contacts
Principal investigator
Name 132578 0
Dr Brenton Baguley
Address 132578 0
Deakin University, 221 Burwood Highway, Burwood, Melbourne, VIC, Australia 3125.
Country 132578 0
Australia
Phone 132578 0
+61 3 92468525
Fax 132578 0
Email 132578 0
b.baguley@deakin.edu.au
Contact person for public queries
Name 132579 0
Brenton Baguley
Address 132579 0
Deakin University, 221 Burwood Highway, Burwood, Melbourne, VIC, Australia 3125.
Country 132579 0
Australia
Phone 132579 0
+61 3 92468525
Fax 132579 0
Email 132579 0
b.baguley@deakin.edu.au
Contact person for scientific queries
Name 132580 0
Brenton Baguley
Address 132580 0
Deakin University, 221 Burwood Highway, Burwood, Melbourne, VIC, Australia 3125.
Country 132580 0
Australia
Phone 132580 0
+61 3 92468525
Fax 132580 0
Email 132580 0
b.baguley@deakin.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?
All of the individual participant data collected during the trial, except the qualitative data from the process evaluation.
When will data be available (start and end dates)?
Data will be available after the main findings from the study are published; no end date determined
Available to whom?
Researchers requesting data only.
Available for what types of analyses?
For individual patient data meta-analysis or to address secondary related (or unrelated) research questions associated with the approval aims/study design.
How or where can data be obtained?
By emailing the Principal Investigator Dr Brenton Baguley via b.baguley@deakin.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.