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Trial registered on ANZCTR

Registration number

ACTRN12621001312831

Ethics application status

Approved

Date submitted

26/07/2021

Date registered

27/09/2021

Date last updated

30/08/2022

Date data sharing statement initially provided

27/09/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Can a telehealth delivered exercise program with nutritional advice be as effective as a supervised clinic-based exercise and nutrition program for weight loss and health enhancement in overweight and obese men with prostate cancer?

Scientific title

Weight loss for overweight and obese prostate cancer patients: a randomised trial of changes in fat mass in a clinic-based versus telehealth delivered exercise and nutrition intervention.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Prostate Cancer

Condition category

Condition code

Cancer

Prostate

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The interventions will consist of a similar resistance and aerobic exercise program performed over 3 sessions per week for 6 months delivered face-to-face (CENUT) in an exercise clinic or via telehealth (TENUT) by Accredited Exercise Physiologists (AEP). Both TENUT and CENUT groups will undertake resistance training comprising 6-12 repetition maximum (RM; i.e. the maximal weight that can be lifted 6 to 12 times which is equivalent to ~60-85% of 1RM) using 1-4 sets per exercise for 6 exercises targeting the major upper and lower body muscle groups performed using different equipment such as exercise machines, dumbbells, Gymsticks™ and elastic bands. Participants will exercise in a group setting of 6-8 people. The aerobic exercise component will involve 15 to 20 minutes of moderate to vigorous intensity cardiovascular exercise using a variety of modes such as walking, jogging or cycling and will be self-directed and undertaken daily. The total duration of the exercise session will be 60 minutes. In addition, participants will also be instructed to perform the general recommendations of 30 min of moderate/vigorous physical activity in the remaining 4 days of the week (a total of 120 minutes per week of moderate physical activity) to achieve at least 300 min of moderate to vigorous physical activity per week. These exercises are up to the participant's choice. For the telehealth intervention we will implement the latest digital platforms and related technological advancements in wearable sensors, online monitoring, cloud-based platforms, and video chat. Participants will receive their exercise program via their smart device or computer, communicate with the AEP and fellow participants by video chat, and be monitored in real-time through the Internet.
For the nutrition intervention, all participants will receive a total of 5 face-to-face or online consultations between 30-60 mins over the first 6 months of intervention (baseline, 2, 12, 18, 24 weeks) with an Accredited Practising Dietitian aiming to: 1) achieve an energy deficit of 2100-4200 kJ/day (500-1000 kcal/day); 2) reducing discretionary items including alcoholic drinks and foods containing refined sugars; and 3) maintain protein intake, as well as the consumption of a 40 g whey protein supplement 3 times per week immediately after the resistance exercise sessions. Safety and monitoring will be assessed by recording the incidence and severity of any adverse events. The TENUT group will have their consultations online while the CENUT group will have face-to-face sessions.
At the end of the first 6-month period, participants from CENUT will receive a booklet created for the study based on previous exercise oncology guidelines (Hayes et al. 2019, Schmitz et al. 2010) with detailed information about a home exercise prescription, while the telehealth program will be maintained without supervision for participants from TENUT. Instructions on performing the home-based exercises and diet will be provided by the AEP and APD.

Intervention code [1]

Lifestyle

Intervention code [2]

Rehabilitation

Intervention code [3]

Treatment: Other

Comparator / control treatment

Telehealth group

Control group

Active

Outcomes

Primary outcome [1]

Fat mass - composite primary outcome
Regional and whole-body fat mass will be derived from a whole-body dual-energy X-ray absorptiometry (DXA; Horizon A, Hologic, Waltham, MA) scan. Trunk adiposity, visceral fat and adipose indices will be assessed using standard procedures.

Timepoint [1]

All measurement study endpoints will take place at baseline, 6 months (end of intervention, primary endpoint) and 12 months (6 months post intervention)

Secondary outcome [1]

Lean mass - composite primary outcome
Regional and whole-body lean mass will be assessed by DXA.

Timepoint [1]

All measurement study endpoints will take place at baseline, 6 months (end of intervention, endpoint) and 12 months (6 months post intervention)

Secondary outcome [2]

Composite Anthropometric measures
Central adiposity will be assessed by waist circumference (WC) and hip circumference (HC). WC will be measured at the level of the narrowest point between the lower costal (rib) border and the iliac crest. HC will be measured at the level of the greatest posterior protuberance of the buttocks which usually corresponds anteriorly to the level of the symphysis pubis. Body mass index (kg.m-2) will also be used to assess weight (kg, measured by digital scales) relative to height (m, measured by stadiometer).

Timepoint [2]

All measurement study endpoints will take place at baseline, 6 months (end of intervention, endpoint) and 12 months (6 months post intervention)

Secondary outcome [3]

SF-36 questionnaire
Health-related quality of life will be assessed using the Medical Outcomes Short Form 36 (SF-36v2).

Timepoint [3]

All measurement study endpoints will take place at baseline, 6 months (end of intervention) and 12 months (6 months post intervention)

Secondary outcome [4]

Blood markers - composite outcome
30 ml of blood samples – testosterone, prostate specific antigen (PSA), lipid profile, insulin, glucose, glycated haemoglobin (HbA1c), C-reactive protein, adiponectin, leptin, insulin-like-growth factor-1 (IGF1), IGF-binding protein-3 (IGFBP3), interleukin 6 (IL6) and tumour necrosis factor (TNF-a) will be measured commercially by an accredited Australian National Association of Testing Authorities (NATA) laboratory (Pathwest Diagnostics, Perth, Western Australia).

Timepoint [4]

All measurement study endpoints will take place at baseline, 6 months (end of intervention) and 12 months (6 months post intervention)

Secondary outcome [5]

1RM - composite measure
One-repetition maximum (1RM) test for chest press and leg press

Timepoint [5]

All measurement study endpoints will take place at baseline, 6 months (end of intervention) and 12 months (6 months post intervention)

Secondary outcome [6]

Nutritional intervention adherence
Nutritional adherence will be assessed using an adapted customised adherence questionnaire designed to provide an estimated frequency of consumption and number of serves of food of interest based on the nutrition advice given. Food items of interest include fruit and vegetables, nuts, high protein foods, dairy, grains and cereals, beverages and alcoholic drinks, discretionary and take-away items. Patients will be asked 25 yes/no questions where a score of 1 given if the patient met a predetermined desired outcome, or a 0 if they didn’t. A higher total score indicates greater compliance with a maximum score of 25.

Timepoint [6]

All measurement study endpoints will take place at baseline, 6 months (end of intervention) and 12 months (6 months post intervention)

Secondary outcome [7]

Safety and monitoring
Patients will be monitored for any adverse events during training and testing by the exercise physiologists with study clinicians overseeing all aspects of patient management where required. Any adverse events reported will be recorded for future assessment. This tool is study specific and comprises date of the event, type of adverse event and further details of the event (i.e. what, where, when, treatment administered etc.). A General practitioner (GP) clearance will be required for continuation in the study.

Timepoint [7]

Each training and testing session

Secondary outcome [8]

Abdominal aortic calcification.
Lateral spine images will be collected for abdominal aortic calcification assessment. Abdominal aortic calcification scores range from 0 to 24 and will be derived from digitally enhanced lateral single-energy images of the thoracolumbar spine. A single experienced investigator will read all images using an established technique. Severity of abdominal aortic calcification will be categorized as previously reported: low (score 0 or 1), moderate (score 2–5), and high (score greater than or equal to 6).

Timepoint [8]

All measurement study endpoints will take place at baseline, 6 months (end of intervention) and 12 months (6 months post intervention)

Secondary outcome [9]

Blood pressure measurement
A validated oscillometric device (HEM-705CP, Omron Corporation, Japan) will be used to record brachial systolic and diastolic blood pressure at the dominant arm in triplicate.

Timepoint [9]

All measurement study endpoints will take place at baseline, 6 months (end of intervention) and 12 months (6 months post intervention)

Secondary outcome [10]

Cancer related questionnaires
Cancer-related quality of life will be measured using the EORTC QLQ-C30 and the EORTC-PR25 for disease-specific health-related quality of life.

Timepoint [10]

All measurement study endpoints will take place at baseline, 6 months (end of intervention) and 12 months (6 months post intervention)

Secondary outcome [11]

FACIT-Fatigue questionnaire
Fatigue will be assessed using the Functional assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire.

Timepoint [11]

All measurement study endpoints will take place at baseline, 6 months (end of intervention) and 12 months (6 months post intervention)

Secondary outcome [12]

BSI-18 questionnaire
The Brief Symptom Inventory-18 (BSI-18) will be used to assess psychological distress across the domains of anxiety, depression and somatisation and global distress severity. These validated instruments are an integrated system to assess quality of life and psychological distress in cancer patients and has been extensively employed in clinical trials of exercise medicine.

Timepoint [12]

All measurement study endpoints will take place at baseline, 6 months (end of intervention) and 12 months (6 months post intervention)

Secondary outcome [13]

Masculinity in Chronic Disease Index questionnaire
The Masculinity in Chronic Disease Index will be used to assess will assess the extent to which men identify with six masculine values: strength; sexual importance/priority; family responsibilities; emotional self-reliance; optimistic capacity and action approach

Timepoint [13]

All measurement study endpoints will take place at baseline, 6 months (end of intervention) and 12 months (6 months post intervention)

Secondary outcome [14]

Working Alliance Inventory questionnaire
Working Alliance Inventory for General Practice tool will be adapted and used to assess the mediations between exercise and nutrition delivery and benefits derived from these programs in men with prostate cancer.

Timepoint [14]

All measurement study endpoints will take place at baseline, 6 months (end of intervention) and 12 months (6 months post intervention)

Secondary outcome [15]

Sub-max test
A submaximal cycle ergometer test (EKBLOM-BAK) will be used for maximal oxygen uptake (VO2max) estimation

Timepoint [15]

All measurement study endpoints will take place at baseline, 6 months (end of intervention) and 12 months (6 months post intervention)

Secondary outcome [16]

400m walk test
A 400-m walk test will be used to measure aerobic capacity and walking endurance

Timepoint [16]

All measurement study endpoints will take place at baseline, 6 months (end of intervention) and 12 months (6 months post intervention)

Secondary outcome [17]

Chair Rise
Repeated chair rise for lower body function.

Timepoint [17]

All measurement study endpoints will take place at baseline, 6 months (end of intervention) and 12 months (6 months post intervention)

Secondary outcome [18]

Composite 6m walk test
6-m (usual walk, fast walk, backwards walk) for gait speed and dynamic balance

Timepoint [18]

All measurement study endpoints will take place at baseline, 6 months (end of intervention) and 12 months (6 months post intervention)

Secondary outcome [19]

GODIN questionnaire
Self-reported physical activity will be assessed by the leisure score index from the Godin Leisure-Time Exercise Questionnaire modified to include a question on resistance training.

Timepoint [19]

All measurement study endpoints will take place at baseline, 6 months (end of intervention) and 12 months (6 months post intervention)

Secondary outcome [20]

Nutrition monitoring
For nutrition monitoring, patients will complete a 3-day weighed food record (3d-WR) over 3 consecutive days (1 weekend day and 2 weekdays) at baseline, 6 and 12 months. This will provide an estimate of total energy intake (kJ/d) and macro- and micronutrients consumed. The 3d-WR data will be analysed using FoodWorks (FoodWorks 10 Professional, Xyris Software Pty Ltd, QLD, Australia).

Timepoint [20]

For nutrition monitoring, patients will complete a 3-day weighed food record (3d-WR) over 3 consecutive days (1 weekend day and 2 weekdays) at baseline, 6 and 12 months.

Eligibility

Key inclusion criteria

One-hundred and four overweight/obese men (52 participants per arm) undergoing treatment or previously treated for prostate cancer involving androgen deprivation therapy (ADT) will be identified and recruited through attending physicians (general practitioner / radiation oncologist / urologist), specialist nurses, advertisements in local newspapers and presentations at cancer support groups and related events in Western Australia.
Inclusion criteria are: 1) body fat percentage great than or equal to 25%, and 2) ability to walk 400-m.

Minimum age

18 Years

Maximum age

No limit

Sex

Males

Can healthy volunteers participate?

Key exclusion criteria

Exclusion criteria are: 1) acute illness or any musculoskeletal, cardiovascular or neurological disorder that could inhibit exercise performance or put participants at risk from exercising, and 2) inability to read and understand English.

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)

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

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

To achieve 80% power at an a level of .025 (one tailed), 43 participants per group will be required to demonstrate a non-inferiority limit below 1.4 kg with a standard deviation of 2.6 kg for fat mass between the telehealth exercise medicine and the clinic-based exercise groups based on our pilot study.
Anticipating an attrition rate of up to 20%, 104 will be recruited for our trial and randomly assigned to one of the exercise groups. Normality of the data will be assessed using the Kolmogorov-Smirnov
test. Baseline characteristics will be analysed using Student’s t-tests or the Mann-Whitney U-test
for continuous measures, as appropriate, and Chi-square for 2020 Prostate Cancer Research Initiative - Sections C Page 3 categorical variables. For the study outcomes, data will be analysed using intention-to-treat and per protocol approaches. Testing for longitudinal changes will be performed using linear mixed models (LMM). Non-inferiority of the intervention for the primary outcome will be implied if the lower limit of a 1-sided 95% confidence interval of the difference between groups between baseline and six months is within the pre-stated limit of 1.4 kg for fat mass.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/11/2021

Actual

12/11/2021

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

104

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Cancer Council Western Australia

Address [1]

Level 1, 420 Bagot Road, Subiaco 6008 WA

Country [1]

Australia

Primary sponsor type

University

Name

Edith Cowan University

Address

Building 21, Level 2, 270 Joondalup Drive, Joondalup WA 6027

Country

Australia

Secondary sponsor category [1]

Charities/Societies/Foundations

Name [1]

Cancer Council Western Australia

Address [1]

Level 1, 420 Bagot Road, Subiaco 6008 WA

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The University Human Research Ethics Committee

Ethics committee address [1]

270 Joondalup Drive, Joondalup WA 6027

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

26/03/2021

Approval date [1]

21/07/2021

Ethics approval number [1]

2021-02157-GALVAO

Summary

Brief summary

This study aims to compare the effectiveness of a telehealth-delivered exercise program against a supervised clinic-based program at improving physical and mental health outcomes for prostate cancer patients.
Who is it for?
You may be eligible for this trial if you are an overweight/obese male aged 18 years or over, undergoing treatment or previously treated for prostate cancer involving androgen deprivation therapy.
Study details
Participants will be randomly assigned to a telehealth-delivered program or the supervised clinic-based program involving resistance and aerobic exercise for 6 months and then will be followed up for an additional 6 months. Additional consultations with a dietitian to address nutritional and dietary changes will also be involved.
Information from this study will help develop a low cost and feasible program to improve the health outcomes of prostate cancer patients.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Daniel Galvao

Address

Building 21, Level 2
Exercise Medicine Research Institute,
Edith Cowan University
270 Joondalup Drive.
JOONDALUP, Perth, WA 6027.

Country

Australia

Phone

+61 8 6304 3420

Fax

[email protected]

Contact person for public queries

Name

Christine Kudiarasu

Address

Building 21, Room 217
Exercise Medicine Research Institute,
Edith Cowan University
270 Joondalup Drive.
JOONDALUP, Perth, WA 6027.

Country

Australia

Phone

+61 8 6304 6089

Fax

[email protected]

Contact person for scientific queries

Name

Christine Kudiarasu

Address

Building 21, Room 217
Exercise Medicine Research Institute,
Edith Cowan University
270 Joondalup Drive.
JOONDALUP, Perth, WA 6027.

Country

Australia

Phone

+61 8 6304 6089

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
11528	Study protocol					381907-(Uploaded-29-04-2021-10-56-30)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Weight loss for overweight and obese patients with prostate cancer: a study protocol of a randomised trial comparing clinic-based versus Telehealth delivered EXercise and nutrition intervention (the TelEX trial).	2022	https://dx.doi.org/10.1136/bmjopen-2021-058899

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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