Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000736842
Ethics application status
Approved
Date submitted
6/04/2021
Date registered
11/06/2021
Date last updated
4/10/2022
Date data sharing statement initially provided
11/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Delivering supervised group exercise to patients with cancer via telehealth: an implementation study
Scientific title
Feasibility and efficacy of delivering supervised group exercise to patients with cancer via telehealth: an implementation study
Secondary ID [1] 303812 0
None
Universal Trial Number (UTN)
Trial acronym
TECS (Telehealth Exercise Cancer Study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 321317 0
Condition category
Condition code
Cancer 319108 319108 0 0
Any cancer
Physical Medicine / Rehabilitation 319109 319109 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study is an implementation study of a telehealth exercise program. Participants with a history of cancer will be invited to join a 12-week, twice-weekly telehealth exercise program delivered by a physiotherapist. In addition to twice-weekly telehealth sessions, participants will complete one prescribed home exercise session.

Participants will be provided with the following equipment to facilitate their exercise: resistance bands plus door anchor, exercise mat, exercise step, activity tracker.

Participants will undergo an initial and post-program assessment involving the measurement of self-reported measures and physical measures. The physical measures at the initial assessment will inform the prescription of exercise type and intensity during the telehealth and home sessions.

The telehealth exercise sessions will be delivered by one physiotherapist and attended by up to five participants. The session will last for approximately 50 mins, and include a warm up, aerobic exercises, resistance exercises, balance, high intensity interval training (HIIT), and flexibility exercises plus a cool down. Adherence to the telehealth exercise sessions will be recorded in the departmental appointment scheduling system.

Exercise prescription in the initial phase of the participant's program will aim for a Borg of 13 (moderate, 40 – 50% VO2 max) (Borg refers to the Borg scale of perceived exertion, 6 = no exertion, 20 = maximal exertion). After the initial phase, the participant will enter the improvement phase, during which exercise prescription will aim for a Borg of 13 – 15 (somewhat hard to hard, 70 – 80% VO2 max). Exercise progression will occur when the Borg is < 11 (fairly light) for 2 – 3 sessions.

The home exercises will be prescribed by the physiotherapist to the participant via PhysiApp, a mobile phone application associated with the website PhysiTrack. This app will provide participants with images and videos as well as the prescription, and allow the participant to log the completed number of sets and reps, for weekly review by the physiotherapist and progression when appropriate. The record of exercises completed logged by the participant in the PhysiApp will be the method of monitoring adherence to the home exercise program. Participants will be asked to complete one home exercise session per week, lasting approximately 30 minutes duration per session. Examples of home exercises include: step ups; theraband bicep curls; lunges; theraband scapular retraction.

The telehealth sessions will be delivered via the platform Virtual Clinic from the Princess Alexandra Hospital (PAH) to participants' homes (computer/laptop/tablet/phone device). The physiotherapists conducting assessments and delivering the telehealth sessions will have experience delivering the in-person exercise program to patients with a cancer diagnosis at PAH, and will have procedural manuals and mentoring from senior physiotherapists within the research team available to support them.
Intervention code [1] 320118 0
Rehabilitation
Intervention code [2] 320575 0
Treatment: Other
Comparator / control treatment
No comparator or control in use.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 326994 0
Cancer-related fatigue, measured with Fatigue Subscale of the Functional Assessment of Chronic Illness Therapy (FACIT) questionnaire
Timepoint [1] 326994 0
Data collected at initial assessment and post-program assessment (after 12-week intervention)
Primary outcome [2] 326995 0
Health-related quality of life, measured with Functional Assessment of Cancer Therapy - General (FACT-G) questionnaire
Timepoint [2] 326995 0
Data collected at initial assessment and post-program assessment (after 12-week intervention)
Primary outcome [3] 326996 0
Exercise self-efficacy, measured with Multidimensional Self-Efficacy for Exercise Scale (MSES) questionnaire
Timepoint [3] 326996 0
Data collected at initial assessment and post-program assessment (after 12-week intervention)
Secondary outcome [1] 393411 0
Presence and severity of symptoms of neurotoxicity and its effects on quality of life, measured with Functional Assessment of Cancer Therapy/Gynaecologic Oncology Group – Neurotoxicity (FACT/GOG-Ntx) scale 13 (version 4) questionnaire
Timepoint [1] 393411 0
Data collected at initial assessment and post-program assessment (after 12-week intervention)
Secondary outcome [2] 393412 0
Cardiorespiratory fitness, measured with the Six Minute Walk Test (6MWT) (objective assessment)
Timepoint [2] 393412 0
Data collected at initial assessment and post-program assessment (after 12-week intervention)
Secondary outcome [3] 393413 0
Muscular strength of the upper and lower limb will be tested using the seated row and leg press resistance machines, respectively, to determine the 6 Repetition Maximum Testing for Upper (UL6RM) and Lower Limb (LL6RM) (objective assessment)
Timepoint [3] 393413 0
Data collected at initial assessment and post-program assessment (after 12-week intervention)
Secondary outcome [4] 393414 0
Lower limb endurance and functional mobility, measured with the 30 seconds sit to stand test. (objective assessment)
Timepoint [4] 393414 0
Data collected at initial assessment and post-program assessment (after 12-week intervention)
Secondary outcome [5] 395641 0
Rhomberg balance test (objective assessment)
Timepoint [5] 395641 0
Data collected at initial assessment and post-program assessment (after 12-week intervention)
Secondary outcome [6] 395642 0
Minutes of moderate-vigorous physical activity across 7 valid wear days. Measured with data collected from wear of Garmin activity tracker during week 1 and week 12 of the intervention program.
Timepoint [6] 395642 0
Data collected from participants during week 1 and week 12 of their programs.
Secondary outcome [7] 395643 0
Adherence to home exercise program, measured with record of home exercise completion in PhysiApp by participant.
Timepoint [7] 395643 0
Data extracted weekly across the 12-week intervention program from PhysiApp.
Secondary outcome [8] 395644 0
Perceptions of participants who attended telehealth exercise classes, measured by (i) questionnaire, using 13 questions with 5-point likert scale responses and 8 other multi-choice questions. (ii) Semi structured interview conducted via telephone or Microsoft TEAMS (up to 30 min in duration).
Timepoint [8] 395644 0
Questionnaire administered at the post-program assessment (immediately after 12-week intervention). Semi-structured interview occurs within 2 weeks of the end of the 12-week intervention program.
Secondary outcome [9] 395645 0
Perceptions of staff who refer to the telehealth program, measured by semi structured interview conducted via telephone or Microsoft TEAMS. (up to 30 min duration)
Timepoint [9] 395645 0
Interviews will occur during 2022, in the second 6 months of the planned study period. Staff will engage in one interview per person.
Secondary outcome [10] 395646 0
Costs incurred and saved by participants who complete the telehealth model of care e.g. transport, parking, time off work, technology, and internet service costs. Measured via questionnaire used in previous work by PI Ward.
Timepoint [10] 395646 0
Once, at the post-program assessment (after 12-week intervention)
Secondary outcome [11] 395647 0
The health service labour required to conduct and manage the telehealth program. Organisational costs will be calculated from the workflow of the Project Officer, including the number and nature of in the interactions occurring the telehealth participants – initial appointments, orientation online sessions, exercise sessions, review of home exercise programs, ad hoc troubleshooting, emails, etc. The cost of the facilities and equipment (e.g. room/s used to assessments and telehealth sessions; telehealth technology) will also be recorded.
Timepoint [11] 395647 0
Data recorded across duration of study by research assistant, to be summed into total cost at the end of the study.

Eligibility
Key inclusion criteria
Cohort one: patients
Patients with a cancer diagnosis who are undergoing oncology treatment or have completed oncology treatment at PAH, who are referred to the exercise class, will form cohort one. The eligibility criteria to participate in this research project are based on the existing criteria for participation in the in-person exercise program.

Inclusion criteria:
• Adults (at least 18 years of age)
• History of cancer for which they are receiving/have received treatment at PAH
• Medical clearance to exercise provided by their treating medical specialist
• Able to provide informed consent
• Access to internet at home suitable for telehealth participation
• Access to smart phone, computer, tablet or other device at home with camera and microphone
• Sufficient space within their home to exercise (4m2 is considered sufficient space)


Cohort two: staff (service stakeholder group)
Inclusion criteria:
• PAH staff member involved in the telehealth model of care as a physiotherapist, referrer, administration officer or line manager
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Cohort One: patients
Exclusion criteria:
• Medical clearance to exercise not given by treating medical specialist – careful consideration will be given to patients with conditions/history including, but not limited to: Significant or active cardiovascular condition; Severe aortic stenosis; Uncontrolled hypertension; Poorly controlled diabetes; Recent pulmonary embolus; Dyspnoea at rest or with minimal activity; Recent major surgery
• Pregnant women
• Non-English speaking background (NESB) requiring the use of an interpreter to access health services
• Those with intellectual or cognitive or psychiatric conditions that, in the judgement of the medical specialist or physiotherapist, could impair ability to safely participate in the class

Cohort Two: staff (service stakeholder group)
No specific exclusion criteria applied to those who meet the inclusion criteria - all participants will be PAH staff members involved in the telehealth model of care as a physiotherapist, referrer, administration officer or line manager

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Cohort characteristics will be prepared to describe the participant (patient) cohort, including socio-demographics and disease- and treatment-related factors. Service outcomes (e.g. recruitment and completion rates, program adherence) will be described with appropriate summary statistics (frequency, percentage, mean, standard deviation). Paired t-tests (normal distribution) or Wilcoxon signed rank tests (non-parametric distribution) will be used to explore (i) changes in patient-reported and physical outcome measures between initial and final assessment and (ii) changes in minutes of moderate to vigorous physical activity in week 1 vs week 12.

Perceptions of participants recorded quantitatively via survey will be analysed using descriptive statistics, including frequency and percentage for results from likert scales.

Perceptions of patients and staff provided during semi-structured interviews will be audio-recorded and transcribed verbatim into the software program NVivo (version 12, QSR, United States) and analysed using thematic analysis as described by Braun and Clarke (2006).

The simple costs data will be presented as appropriate summary statistics, and for each participant, the potential savings will be subtracted from the actual costs incurred, to produce an estimated total cost.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
14/06/2021
Actual
28/07/2021
Date of last participant enrolment
Anticipated
Actual
13/05/2022
Date of last data collection
Anticipated
Actual
30/06/2022
Sample size
Target
43
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 19469 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 33574 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 308210 0
Charities/Societies/Foundations
Name [1] 308210 0
PA Research Foundation
Country [1] 308210 0
Australia
Primary sponsor type
Hospital
Name
Princess Alexandra Hospital
Address
199 Ipswich Road, Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 308993 0
None
Name [1] 308993 0
n/a
Address [1] 308993 0
n/a
Country [1] 308993 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308191 0
Metro South Health Human Research Ethics Committee
Ethics committee address [1] 308191 0
Ethics committee country [1] 308191 0
Australia
Date submitted for ethics approval [1] 308191 0
14/01/2021
Approval date [1] 308191 0
15/03/2021
Ethics approval number [1] 308191 0
HREC/2021/QMS/72886

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

Contacts
Principal investigator
Name 109870 0
Dr Elise Gane
Address 109870 0
Physiotherapy Department
Princess Alexandra Hospital
198 Ipswich Road
Woolloongabba QLD 4102
Country 109870 0
Australia
Phone 109870 0
+61 7 3176 4879
Fax 109870 0
Email 109870 0
[email protected]
Contact person for public queries
Name 109871 0
Elise Gane
Address 109871 0
Physiotherapy Department
Princess Alexandra Hospital
198 Ipswich Road
Woolloongabba QLD 4102
Country 109871 0
Australia
Phone 109871 0
+61 7 3176 4879
Fax 109871 0
Email 109871 0
[email protected]
Contact person for scientific queries
Name 109872 0
Elise Gane
Address 109872 0
Physiotherapy Department
Princess Alexandra Hospital
198 Ipswich Road
Woolloongabba QLD 4102
Country 109872 0
Australia
Phone 109872 0
+61 7 3176 4879
Fax 109872 0
Email 109872 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.