Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001417875
Ethics application status
Approved
Date submitted
8/09/2021
Date registered
21/10/2021
Date last updated
13/03/2023
Date data sharing statement initially provided
21/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
TeleCaRe: Expanding delivery of Cancer Rehabilitation via telehealth
Scientific title
Expanding delivery of Cancer Rehabilitation via telehealth: a randomized controlled trial comparing rehabilitation delivered via telehealth to usual care for cancer suvivor's quality of life.
Secondary ID [1] 305259 0
None
Universal Trial Number (UTN)
U1111-1269-3189
Trial acronym
TeleCaRe
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
cancer 323533 0
Condition category
Condition code
Cancer 321098 321098 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Brief Name: Cancer Telerehabilitation
Why: Telehealth is now more common in health service settings
What: Materials
• 2x weekly online group exercise (approximately 6 participants)
• Participants to receive an online (Physitrack, London, UK), individualised home exercise program and exercise band
• Participants to receive access to an online information portal (iLearn) with webinars, online information handouts and resources available from the health service e.g. Cancer Council booklets
• Participants will wear a physical activity device (Fitbit Inspire) continuously during waking hours for 8 weeks.
• Written handout of exercise options provided at 8 weeks
What Procedures:
Provider
• One physiotherapist with oncology experience
• One allied health assistant
How
• Supervised sessions via video-conference (Zoom)
• Physical activity device (Fitbit Inspire) for remote exercise and physical activity monitoring
• Home exercise program provided by Physitrack app
• Education material provided by Eastern Health iLearn platform
Where
• Clinicians hospital-based, patients home-based
When/How much:
Intensity
Aerobic: Moderate (BORG 3-5, 60-85% HRmax); supervised aerobics
Resistance: 2-3 sets 10-12 RM; free weights, resistance bands, body weight and functional exercise
Participants progressed when completing 3x10-12 repetitions
Frequency 2x weekly supervised training
60-minute online exercise group
Duration 8 weeks
Tailoring
• Individualised exercise program based on a 60-minute initial in-person consultation with a physiotherapist including exercise assessment and goal setting
Trial fidelity
• Physiotherapy staff who are employed by the hospital to provide the intervention will be provided training and mentoring by a senior research physiotherapist with oncology experience
• Electronic exercise log via Physitrack app and Fitbit Inspire
• Records of the number and duration of completed sessions.
• Clinical supervision as per standard hospital policy
• Record of any exercise interventions patients have participated in outside the trial
Intervention code [1] 321649 0
Rehabilitation
Comparator / control treatment
Brief Name: Usual Care
Why: Cancer survivors are not routinely offered cancer rehabilitation
What: Materials
• Participants to receive standard information booklets about cancer care and recovery available from the health service e.g. Cancer Council booklets
• Written handout of exercise options provided at 8 weeks
What Procedures
Provider
• Usual care team (e.g. specialist, general practitioner, allied health professional).
• One physiotherapist with oncology experience provided by the hospital will provide exercise guidelines in written format

How • In-person or via telehealth as available
Where • Hospital or home as indicated
When/How much
Intensity
Physical activity advice in accordance with current physical activity recommendations:
• Moderate (60-85% HRmax, 2-3 sets, 10-12 repetitions)
Duration 8 weeks
Tailoring
• None
Trial fidelity
• Physiotherapy staff who are employed by the hospital to provide the intervention will be provided training and mentoring by a senior research physiotherapist with oncology experience
• Clinical supervision as per standard hospital policy
• Record of any exercise interventions patients have participated in outside the trial
Control group
Active

Outcomes
Primary outcome [1] 328876 0
Health-related Quality of life measured by European Organization for Research and Treatment of Cancer QoL Questionnaire-C30 (EORTC-QLQ C30)
Timepoint [1] 328876 0
Post-intervention: Baseline, immediately post-intervention: week 9 (primary end point), 4-months post intervention completion
Secondary outcome [1] 400747 0
Adverse events collected by study-specific questionnaire and graded by CTCAE v4
Timepoint [1] 400747 0
immediately post intervention: week 9
Secondary outcome [2] 400748 0
Physical capacity: 6-minute walk test
Timepoint [2] 400748 0
Baseline, Week 9 (immediately post-intervention)
Secondary outcome [3] 400749 0
Physical activity measured by activPAL: amount of moderate physical activity
Timepoint [3] 400749 0
Baseline, 4 months post intervention
Secondary outcome [4] 400750 0
Self efficacy measured by questionnaire developed by research team based on the Health Action Process Approach
Timepoint [4] 400750 0
Baseline, Week 9 (immediately post-intervention)
Secondary outcome [5] 400751 0
Health service utilisation: readmissions, hospital LOS associated with readmission, ED presentations using routinely collected hospital data
Timepoint [5] 400751 0
Baseline, 4 months post intervention
Secondary outcome [6] 400752 0
consumer perceptions via semi-structured interview
Timepoint [6] 400752 0
week 9 and 4 months post intervention
Secondary outcome [7] 401413 0
health service data including allied health and medical services, pharmaceutical use, and hospital admissions (external to the health service) using questionnaire developed by research team
Timepoint [7] 401413 0
Baseline, 4-months post intervention
Secondary outcome [8] 401414 0
Physical activity measured by activPAL: daily steps
Timepoint [8] 401414 0
Baseline, 4-months post intervention
Secondary outcome [9] 401415 0
Physical activity measured by activPAL: daily walk time
Timepoint [9] 401415 0
Baseline, 4-months post intervention
Secondary outcome [10] 401416 0
Physical activity measured by activPAL: sedentary behaviour
Timepoint [10] 401416 0
Baseline, 4-months post intervention
Secondary outcome [11] 408478 0
Participants in both groups will also be asked whether they received any exercise-based intervention outside of the trial to assess trial fidelity using a questionnaire developed by the researchers.
Timepoint [11] 408478 0
week 9 and 4 months post intervention

Eligibility
Key inclusion criteria
• Are aged 18 years and over.
• Have a cancer diagnosis.
• Living independently in the community (i.e. not a current inpatient or residential aged care resident)
• Are receiving cancer treatment (palliative or curative intent) or are within 12 months of completing adjuvant therapy (except for long term oral hormonal therapies).
• Have an Australian Karnofsky Performance Status score of equal to or greater than 60.
• Can speak conversational English.
• Have access to and are willing to use internet.
• Are able to give written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• They are deemed unsafe to exercise. A physiotherapist will screen for absolute exercise contra-indications in the medical record: unstable angina/hypertension/heart failure, arrhythmia, acute embolus/infarct, acute systemic infection with fever, dissecting aneurysm, acute myocarditis or pericarditis. The physiotherapist will obtain physician clearance to exercise if patient’s bloods and vital signs fall outside acceptable values. If patients have a medical condition that contraindicates participation in an exercise-based rehabilitation program as assessed by a physiotherapist or medical practitioner, they will be excluded.
• They have an Australian-modified Karnofsky Performance status of <60.
• They are an inpatient or residing in aged care.
• They have a cognitive impairment that precludes their ability to provide written, informed consent as assessed by their treating clinician.
• They are a high falls risk as determined by their treating clinician and/or FROP-COM screening score >4

Change made prior to enrolment commencement

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)
The allocation sequence will be generated using an online computer-generated randomisation program, by an academic independent from this research team. Allocation will be concealed from the participant and researchers until eligibility for the study has been determined, participants have consented to take part, and completed baseline assessment. Participants will be allocated by the trial coordinator after baseline assessment by contacting the independent researcher by email for random group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The allocation sequence will be generated using permuted blocks from an online computer-generated randomisation program, www.randomization.com by an academic independent from this research team
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
It is estimated 104 participants will be required to be sufficient for power of 0.80 and a two-tailed alpha level of 0.05 to detect a between group difference of a 10 point change in EORTC QLQ-C30 quality of life score,62 the minimally important difference established for people with cancer, assuming an SD of 18 points.42 Based on our previous trial of cancer rehabilitation,42 we expect dropout of 10%, therefore 116 participants will be randomised.
Approximately 20 participants in the telerehabilitation group will be recruited for the qualitative component of the study. It is anticipated this will be sufficient to demonstrate saturation of themes based on our previous qualitative findings related to cancer rehabilitation. (Dennett et al 2019, 2020).



Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
11/04/2022
Actual
11/04/2022
Date of last participant enrolment
Anticipated
30/09/2023
Actual
Date of last data collection
Anticipated
2/02/2024
Actual
Sample size
Target
116
Accrual to date
71
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 20490 0
Box Hill Hospital - Box Hill
Recruitment hospital [2] 20491 0
Maroondah Hospital - Ringwood East
Recruitment hospital [3] 20492 0
Yarra Ranges Health - Lilydale
Recruitment hospital [4] 20493 0
Healesville & District Hospital - Healesville
Recruitment hospital [5] 20494 0
Wantirna Health - Wantirna
Recruitment postcode(s) [1] 35262 0
3128 - Box Hill
Recruitment postcode(s) [2] 35263 0
3135 - Ringwood East
Recruitment postcode(s) [3] 35264 0
3140 - Lilydale
Recruitment postcode(s) [4] 35265 0
3777 - Healesville
Recruitment postcode(s) [5] 35266 0
3152 - Wantirna

Funding & Sponsors
Funding source category [1] 309628 0
Government body
Name [1] 309628 0
Victorian Cancer Agency
Country [1] 309628 0
Australia
Primary sponsor type
Hospital
Name
Eastern Health
Address
Level 2, 5 Arnold St, Box Hill
Victoria 3128
Country
Australia
Secondary sponsor category [1] 310647 0
None
Name [1] 310647 0
Address [1] 310647 0
Country [1] 310647 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309403 0
Eastern Health Human Research Ethics Committee
Ethics committee address [1] 309403 0
Ethics committee country [1] 309403 0
Australia
Date submitted for ethics approval [1] 309403 0
Approval date [1] 309403 0
01/09/2021
Ethics approval number [1] 309403 0
E21-012-74698
Ethics committee name [2] 310717 0
La Trobe University Human Ethics Committee
Ethics committee address [2] 310717 0
Ethics committee country [2] 310717 0
Australia
Date submitted for ethics approval [2] 310717 0
20/09/2021
Approval date [2] 310717 0
15/09/2021
Ethics approval number [2] 310717 0
E21-012-74698

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

Contacts
Principal investigator
Name 114034 0
Dr Amy Dennett
Address 114034 0
Eastern Health
Level 2, 5 Arnold St, Box Hill
Victoria 3128
Country 114034 0
Australia
Phone 114034 0
+61 390952442
Fax 114034 0
Email 114034 0
[email protected]
Contact person for public queries
Name 114035 0
Amy Dennett
Address 114035 0
Eastern Health
Level 2, 5 Arnold St, Box Hill
Victoria 3128
Country 114035 0
Australia
Phone 114035 0
+61 390952442
Fax 114035 0
Email 114035 0
[email protected]
Contact person for scientific queries
Name 114036 0
Amy Dennett
Address 114036 0
Eastern Health,
Level 2, 5 Arnold St, Box Hill
Victoria 3128
Country 114036 0
Australia
Phone 114036 0
+61 390952442
Fax 114036 0
Email 114036 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?
Individual participant data underlying published results only
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Anyone who wishes to access it
Available for what types of analyses?
Any purpose
How or where can data be obtained?
Unrestricted access via supplementary file of publication


What supporting documents are/will be available?




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.