ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620001054909

Ethics application status

Approved

Date submitted

10/08/2020

Date registered

16/10/2020

Date last updated

16/10/2020

Date data sharing statement initially provided

16/10/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Towards best practice in the delivery of prescribed exercise via Telehealth for individuals diagnosed with cancer undergoing active treatment.

Scientific title

Exploring the feasibility and efficacy of an exercise intervention delivered via Telehealth for individuals diagnosed with cancer: A mixed methods design.

Secondary ID [1]

Nil known.

Universal Trial Number (UTN)

U1111-1256-4083

Trial acronym

Linked study record

N/A.

Health condition

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

Cancer - confirmed via radiological or pathological diagnosis. Any diagnosis, treatment modality and stage of disease will be included.

Condition category

Condition code

Cancer

Any cancer

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A two-arm (1:1) randomised control trial will compare an eight week online supervised exercise program to usual care in patients undergoing active cancer treatment. Telehealth delivery will involve an online exercise intervention in a group setting via the online platform Zoom.

Arm 1: Telehealth Exercise Intervention
- Delivery of intervention by two ESSA Accredited Exercise Physiologists (AEP) with a minimum of 1 years experience in delivering exercise to cancer patients within a specialist oncology centre. The AEPs involved will also have had additional training and experience in delivering online supervised exercise.
- Group exercise sessions will occur via Zoom, with each participant in their own living residence. Group sessions will be capped at 8 participants per session and supervised by an ESSA AEP.
- The intervention will be delivered 1hr 1 x week for 8 weeks.
- Each exercise program will be individually tailored to suit each participants needs, determined by an initial assessment prior to the intervention which will be conducted by an ESSA AEP.
- Symptoms will be monitored pre/post exercise sessions using a symptom assessment scale via an online survey platform.
- Participants will be provided with an electronic and hard copy safety booklet outlining best practice for measuring blood pressure (BP), temperature and if diabetic, blood glucose levels (BGLs). In addition, this booklet covers information regarding when not to exercise, and what to do if experiencing an abnormal exercise response. The booklet has been designed specifically for this study, and was designed by a team of Accredited Exercise Physiologists which experience working in exercise oncology.
- Exercise programs will be developed according to the equipment each participant has in their own home; no specific exercise equipment will be required.

Arm 2: Standard Care (control group)
- Provision of current Australian physical activity guidelines.

Given the variability in treatment types and tolerance in people diagnosed with cancer, a specific breakdown of sessions cannot be provided as individualised programs will vary in intensity, mode. Participants will complete the individualised programs DURING the Zoom group sessions. A modified Borg RPE and/or dyspnoea scale may be utilised for some individuals however this will depend on their history, current medical status and additional comorbidities.

Adherence to the intervention will be monitored via a session attendance checklist to mark off attendees which will be completed by the supervising AEP.

Intervention code [1]

Lifestyle

Comparator / control treatment

Arm 2: Standard care (control group).
Participants in Arm 2 will receive an electronic and hard copy of the Australian guidelines for physical activity. Due to the known benefits of physical activity for cancer patients, it is unethical to ask participants to completely abstain from exercise. Participants in this arm will undergo a baseline assessment prior to randomisation, however will not participate in the Telehealth exercise program.

Control group

Active

Outcomes

Primary outcome [1]

Feasibility statistics: exercise session attendance, drop-out rates and study completion rates will be analysed as a percentage of the sample size in Arm 1 to determine the feasibility of the study. The percentage of eligible participants who expressed interest but declined to participate (with reasons) will also be recorded. This data will be tracked throughout the intervention and finalised at the completion of the trial.
Study completion rates: participants will only be considered as having completed the study if more than or equal to 80% of sessions are attended across the eight weeks.

Timepoint [1]

Baseline assessment, week 4 and week 8; Arm 1 and 2.

Primary outcome [2]

Change in psychological wellbeing, measured by a reduction in the DASS-21.

Timepoint [2]

Baseline assessment, week 4 and week 8; Arm 1 and 2.

Primary outcome [3]

Change in physical activity levels, measured by minutes/hours of activity determined by the Active Australia Survey instrument.

Timepoint [3]

Baseline assessment, week 4 and week 8; Arm 1 and 2.

Secondary outcome [1]

Symptom management - assessed by the Memorial Symptom Assessment Scale. This instrument will be used as a screening tool rather than a specific outcome measure to identify any new or unusual symptoms that may require further investigation or impact exercise participant.

Timepoint [1]

Before and after each exercise session for the entire 8 week intervention; Arm 1 only.

Secondary outcome [2]

Qualitative Experience: Arm 1 only.
An online interview with a member of the research team will be conducted with a sub-sample of ten participants from the exercise group. The interview will follow a semi-structured format and will be audio recorded using a digital recording device. This interview is designed to explore participants experiences of the online exercise sessions and offers an avenue for participants to provide feedback about the program.

The sub-sample will be determined by the first 10 participants who agree to the interview.
The interview will be conducted in a one-on-one format via an online video conferencing platform.

Timepoint [2]

Within 7 days of completing the 8 week intervention.

Secondary outcome [3]

Change in wellbeing, assessed by the FACT-G questionnaire.

Timepoint [3]

Baseline assessment, week 4 and week 8; Arm 1 and 2.

Eligibility

Key inclusion criteria

- Age equal to or more than 18 years.
- Current diagnosis of cancer (confirmed by pathological or radiological diagnosis).
- Self-assessed written and verbal English proficiency.
- Ability to provide informed consent.
- Written medical clearance from primary care physician or oncologist to participate in online individually prescribed exercise.
- Ownership of a smartphone, computer, laptop or tablet to access Zoom platform.
- Ownership of an automatic blood pressure monitor, digital thermometer and if diabetic, a blood glucose monitor.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- No recent myocardial infarction or other acute cardiac events within the last 2 days.
- No unstable angina.
- No uncontrolled cardiac arrhythmia, causing symptoms or hemodynamic compromise.
- No active endocarditis.
- No acute myocarditis or pericarditis.
- No symptomatic severe aortic stenosis.
- No decompensated heart failure.
- No acute pulmonary embolism, pulmonary infarction or deep venous thrombosis.
- No acute aortic dissection.
- No physical disability which precludes safe and adequate exercise testing or participation.
- No known blood counts below normal levels (white blood cells, platelets and haemoglobin).
- No unusual chest pain, dizziness, blurred vision, loss of consciousness or shortness of breath.

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)

Participants will be randomised in a ratio of 1:1 to two study arms. A researcher at the University of Canberra external to the protect with no participant contact will be responsible for randomisation using a concealed, computer generated sequence. This researcher will then provide the AEPs with the randomisation schedule, therefore the primary researcher will be blinded to the allocation.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Simple randomisation: computerised 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

Quantitative Data: The questionnaire data will be analysed with a general linear mixed model using the R package lme4 (R Core Team 2018). A random intercept for participants will be included to account for intraindividual dependencies and interindividual heterogeneity. This will also allow for individual baseline adjustment. All models will be estimated using Restricted Maximum Likelihood. P-values will be obtained using Type II Wald F tests with Kenward-Roger degrees of freedom as implemented in the R package car (Fox and Weisberg 2011). Statistical significance will be determined on p = 0.05, in addition, confidence intervals (CI) will be assessed whether they included zero or not. Results will be reported as mean estimates and 95% confidence intervals.

Qualitative Data: Qualitative data from the semi-structured interviews will be analysed utilising a six-staged thematic approach. This method is used to identify, analyse and report patterns or themes within the data. An inductive approach will be taken to analyse the data, allowing for themes to be data driven. The data will be accepted at face value and the assumption will be made that participants reports are a true reflection of their experiences. Qualitative data analysis will be completed by two members of the research team, with any discrepancies in codes, categories or themes discussed with a third member. NVivo software will be employed to organise codes and the Consolidated Criteria for Reporting Qualitative Research (COREQ) checklist will be used when displaying the analysed data.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

19/10/2020

Actual

Date of last participant enrolment

Anticipated

28/02/2021

Actual

Date of last data collection

Anticipated

30/04/2021

Actual

Sample size

Target

160

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment hospital [1]

Icon Cancer Centre Canberra - Bruce

Recruitment postcode(s) [1]

2617 - University Of Canberra

Recruitment postcode(s) [2]

2617 - Bruce

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Canberra internal SEED grants.

Address [1]

11 Kiranari Street, Bruce, ACT 2617.

Country [1]

Australia

Primary sponsor type

University

Name

University of Canberra

Address

Faculty of Health, University of Canberra, Canberra Specialist Medical Centre, Level C Office 3, Bruce 2617, Canberra.

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Canberra Human Research Ethics Committee

Ethics committee address [1]

11 Kirinari Street, Bruce ACT 2617

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/07/2020

Approval date [1]

08/09/2020

Ethics approval number [1]

ID: 4604

Summary

Brief summary

The purpose of this study is to explore the pitfalls and showcase best practices of using telehealth to provide exercise to cancer patients, and explore whether results are comparable to face-to-face delivery of exercise.

Who is it for?
You may be eligible for this study if you are an adult who has been diagnosed with cancer.

Study details
Participants in this study will randomly receive one of two treatments:
1. An 8-week exercise program, where participants will join an online Zoom group teleconference and complete exercises as prescribed by the study team.
2. Physical and online copies of the current Australian Guidelines for Physical Activity.

It is hoped that this research will help to determine whether the use of telehealth is beneficial to cancer patients and whether it is a useful alternative option to face-to-face exercise therapy.

Note: this brief summary is intended for lay audience.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Kellie Toohey

Address

Faculty of Health, University of Canberra, Canberra Specialist Medical Centre, Corner of Allawoona and Broula Street, Level C Office 3, Bruce 2617, Canberra, Australia.

Country

Australia

Phone

+61 2 62068873

Fax

kellie.toohey@canberra.edu.au

Contact person for public queries

Name

Kellie Toohey

Address

Faculty of Health, University of Canberra, Canberra Specialist Medical Centre, Corner of Allawoona and Broula Street, Level C Office 3, Bruce 2617, Canberra, Australia.

Country

Australia

Phone

+61 2 62068873

Fax

kellie.toohey@canberra.edu.au

Contact person for scientific queries

Name

Kellie Toohey

Address

Faculty of Health, University of Canberra, Canberra Specialist Medical Centre, Corner of Allawoona and Broula Street, Level C Office 3, Bruce 2617, Canberra, Australia.

Country

Australia

Phone

+61 2 62068873

Fax

kellie.toohey@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?

All data collected will be shared - this will be de-identified, raw, line-by-line data.

When will data be available (start and end dates)?

At the conclusion of the trial, approximate estimate April 2021. The data will be available for 5 years from the conclusion of the trial.

Available to whom?

Case by case at the discretion of the primary investigator.

Available for what types of analyses?

For IPD meta-analyses.

How or where can data be obtained?

By contacting the primary investigator Kellie Toohey via email - kellie.toohey@canberra.edu.au.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
8675	Study protocol			kellie.toohey@canberra.edu.au
8678	Ethical approval			kellie.toohey@canberra.edu.au

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	Towards best practice in the delivery of prescribed exercise via telehealth for individuals diagnosed with cancer: A randomised controlled trial protocol.	2022	https://dx.doi.org/10.1016/j.cct.2022.106833

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

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