Trial Review

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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] 301933 0
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. 318466 0
Condition category
Condition code
Cancer 316468 316468 0 0
Any cancer
Physical Medicine / Rehabilitation 316957 316957 0 0
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] 318221 0
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] 324620 0
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] 324620 0
Baseline assessment, week 4 and week 8; Arm 1 and 2.
Primary outcome [2] 324621 0
Change in psychological wellbeing, measured by a reduction in the DASS-21.
Timepoint [2] 324621 0
Baseline assessment, week 4 and week 8; Arm 1 and 2.
Primary outcome [3] 324622 0
Change in physical activity levels, measured by minutes/hours of activity determined by the Active Australia Survey instrument.
Timepoint [3] 324622 0
Baseline assessment, week 4 and week 8; Arm 1 and 2.
Secondary outcome [1] 385228 0
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] 385228 0
Before and after each exercise session for the entire 8 week intervention; Arm 1 only.
Secondary outcome [2] 385229 0
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] 385229 0
Within 7 days of completing the 8 week intervention.
Secondary outcome [3] 386704 0
Change in wellbeing, assessed by the FACT-G questionnaire.
Timepoint [3] 386704 0
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?
No
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] 17458 0
Icon Cancer Centre Canberra - Bruce
Recruitment postcode(s) [1] 30891 0
2617 - University Of Canberra
Recruitment postcode(s) [2] 31189 0
2617 - Bruce

Funding & Sponsors
Funding source category [1] 306347 0
University
Name [1] 306347 0
University of Canberra internal SEED grants.
Country [1] 306347 0
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] 306853 0
None
Name [1] 306853 0
Address [1] 306853 0
Country [1] 306853 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306556 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 306556 0
Ethics committee country [1] 306556 0
Australia
Date submitted for ethics approval [1] 306556 0
17/07/2020
Approval date [1] 306556 0
08/09/2020
Ethics approval number [1] 306556 0
ID: 4604

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

Contacts
Principal investigator
Name 104278 0
Dr Kellie Toohey
Address 104278 0
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 104278 0
Australia
Phone 104278 0
+61 2 62068873
Fax 104278 0
Email 104278 0
[email protected]
Contact person for public queries
Name 104279 0
Kellie Toohey
Address 104279 0
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 104279 0
Australia
Phone 104279 0
+61 2 62068873
Fax 104279 0
Email 104279 0
[email protected]
Contact person for scientific queries
Name 104280 0
Kellie Toohey
Address 104280 0
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 104280 0
Australia
Phone 104280 0
+61 2 62068873
Fax 104280 0
Email 104280 0
[email protected]

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 - [email protected].


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
8675Study protocol  [email protected]
8678Ethical approval  [email protected]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseTowards best practice in the delivery of prescribed exercise via telehealth for individuals diagnosed with cancer: A randomised controlled trial protocol.2022https://dx.doi.org/10.1016/j.cct.2022.106833
N.B. These documents automatically identified may not have been verified by the study sponsor.