Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001007729
Ethics application status
Approved
Date submitted
13/07/2022
Date registered
18/07/2022
Date last updated
1/09/2024
Date data sharing statement initially provided
18/07/2022
Date results provided
1/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of a behavioural counselling intervention on physical activity levels in cancer inpatients (CanFit): randomised controlled trial
Scientific title
The effect of a behavioural counselling intervention on physical activity levels in cancer inpatients (CanFit): randomised controlled trial
Secondary ID [1] 307542 0
None
Universal Trial Number (UTN)
U1111-1280-2551
Trial acronym
CanFit
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 326976 0
Condition category
Condition code
Cancer 324166 324166 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
WHAT: MATERIALS
• Fitbit Inspire device worn for duration of hospital admission
• Physical activity diary (provided day 1) + standardised physical handout (readily available from Exercise is Medicine on how to sit less and move more) (provided on discharge)
• Standard exercise and cancer booklet (provided day 1 from Cancer Council)
WHAT PROCEDURES
PROVIDER
• Health professional trained to provide intervention in addition to usual ward staff as indicated: nursing, medical, allied health
HOW • Individual face-to-face counselling including feedback of step counts and goal setting/review of goals.
During session one, masking of the Fitbit display will be removed, and the health professional will discuss the benefits of physical activity and formulate an initial daily step goal in collaboration with the patient, taking into consideration their baseline assessment results, day 1 Fitbit data and current medical management. The daily step goal will be displayed in the patient’s room on their bedside whiteboard to reinforce the step goal. Patients will be able to actively monitor their step count throughout admission on the Fitbit display of the watch. All ward staff will be trained to use the Fitbit step count data and encourage patients to meet their physical activity goals at every encounter.
During session two, the health professional will review the patients step counts from the first half of their admission through the Fitbit dashboard application and patient’s diary and revise the step goal accordingly to ensure it is achievable. They will also discuss with the patient how they plan to increase their physical activity when they are discharged home
WHERE • Acute hospital ward
WHEN/HOW MUCH
2 behavioural counselling sessions (Day 1 and mid admission (approx D3)) during hospital admission plus usual care physiotherapy as indicated for safety, gait aid progression, discharge planning. Usual care physiotherapy will be provided during and after hospital admission as per hospital guidelines.
Each session up to 15 minutes duration over a period of 7 days or until hospital discharge (whichever is earlier)

TAILORING • Individualised physical activity goal setting using Fitbit and step diary. Patients will be encouraged to increase their step count by 10-30% per day (approximately 100 to 500 steps) based on their initial step count prior to randomisation.
ADHERENCE Adherence to step goals and completion of step diaries will be recorded for participants in the intervention group. Data from step diaries will be compared with electronic data from the Fitbit device which will be uploaded to the Fitbit Dashboard desktop application.
FIDELITY Record of number and duration of completed sessions, step logs as recorded by fitbit application and patient.
Intervention code [1] 324000 0
Behaviour
Intervention code [2] 324001 0
Treatment: Other
Intervention code [3] 324002 0
Rehabilitation
Comparator / control treatment
Usual Care - Hospitalised inpatients do not routinely receive physical activity interventions including behaviour change interventions such as goal setting and feedback.
MATERIALS • Standard exercise and cancer booklet (from cancer council, provided on hospital discharge, )
WHAT PROCEDURES
• Usual ward staff as indicated: nursing, medical, allied health
• Usual in-patient care provided in person
SETTING
• Acute hospital ward
WHEN/HOW MUCH
Usual care physiotherapy as indicated for safety, gait aid progression, discharge planning will be provided for approximately 15 minutes each session during hospital admission (7 days (or until discharge)). Will be provided during and after hospital admission as per hospital guidelines.
TAILORING: none
Control group
Active

Outcomes
Primary outcome [1] 331977 0
Physical activity assessed using activPAL accelerometer
During the inpatient period, physical activity will be expressed as number of steps in 24 hours (day 5-7).
Timepoint [1] 331977 0
Day 5 of admission (or 2 days prior to discharge if less than 7 day admission)
Secondary outcome [1] 411779 0
Physical activity assessed using activPAL accelerometer
At 30-day follow-up, physical activity will be expressed as average daily steps over 7 days
Timepoint [1] 411779 0
30 days post hospital discharge
Secondary outcome [2] 411780 0
Sedentary behaviour (sitting and lying) assessed using activPAL
During inpatient admission sedentary behaviour will be expressed as time spent sitting and lying (sedentary time) during 24 hours (day 5-7)
At 30-day follow-up, sedentary behaviour will be expressed as average time spent sitting and lying over 7 days
Timepoint [2] 411780 0
Day 5 of hospital admission (or 2 days prior to discharge if less than 7 day admission) and 30 days post hospital discharge.
Secondary outcome [3] 411781 0
Physical function using the De Morton Mobility Index (DEMMI).
Timepoint [3] 411781 0
Baseline, hospital discharge (day 5 to 7), 30 days post-discharge
Secondary outcome [4] 411782 0
Self-efficacy for physical activity by the Physical Exercise Self-Efficacy scale
Timepoint [4] 411782 0
Baseline, 30-days post hospital discharge
Secondary outcome [5] 411783 0
Adverse events as defined by the World Health Organization during the hospital admission will be recorded from medical records and by participant self-report to document safety of the intervention.
Possible adverse events include:
exacerbation of symptoms such as pain, dizziness, fatigue
falls
cardiovascular event (e.g. heart attack or stroke)
Timepoint [5] 411783 0
Day 7 (or hospital discharge), 30-days post hospital discharge
Secondary outcome [6] 411786 0
Emergency department presentations from routinely collected hospital data and the electronic medical record
Timepoint [6] 411786 0
30 days post hospital discharge
Secondary outcome [7] 411787 0
Hospital re-admissions including number of nights admitted collected from routinely collected hospital data and the electronic medical record
Timepoint [7] 411787 0
30 days post hospital discharge
Secondary outcome [8] 411892 0
number of allied health sessions received during and after hospital admission collected from routinely collected hospital data and the electronic medical record
Timepoint [8] 411892 0
Day 7 (or hospital discharge) and 30 days post-discharge
Secondary outcome [9] 426547 0
Patient acceptability via survey designed for this study
Timepoint [9] 426547 0
>30 days after discharge from hospital
Secondary outcome [10] 426548 0
staff feedback via semistructured interview to assess feasibility of the trial
Timepoint [10] 426548 0
10 months after trial commencement

Eligibility
Key inclusion criteria
Participants will be eligible if they:
• Admitted to the oncology/haematology ward at Box Hill Hospital
Are aged 18 years and over.
• Have a cancer diagnosis.
• Are able to ambulate independently with our without an aid.
• Are receiving inpatient care with expected admission of at least 3 days.
• Have an Australian Karnofsky Performance Status score of 50 or greater
• Are able to give written informed consent as recorded in the medical record or as assessed by their treating clinician or trial assessor.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if:
• They are non-ambulant or deemed unsafe to walk outside of their room independently. A physiotherapist will screen for absolute contra-indications to walking in the medical record: unstable angina/hypertension/heart failure, arrhythmia, acute embolus/infarct, acute systemic infection with haemodynamic instability, 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 to walk as assessed by a physiotherapist or medical practitioner, they will be excluded.
• They are expected to be admitted for <3 days (e.g. for the purposes of chemotherapy administration)
• They usually live in residential care.

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)
allocation involves contacting the holder of the allocation schedule who was "off-site"
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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
The primary outcome (steps per day on discharge) will be analysed using linear mixed effects models. This method accounts for within-participant dependence of observations over time, and for missing data, allowing some participants to have missing observations at certain time points. If more than 5% of data are missing, a multiple imputation process will be used, providing the assumption data are missing at random is met. A similar approach will be used for analysis of continuous secondary outcomes collected longitudinally. The number of emergency department, and hospital admissions will be reported as an incidence rate ratio using a negative binomial regression model. To avoid bias and to maximize the randomisation process, all available data will be analysed according to allocation (intention to treat analysis), regardless of compliance.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/09/2022
Actual
18/08/2022
Date of last participant enrolment
Anticipated
28/06/2024
Actual
23/02/2023
Date of last data collection
Anticipated
20/04/2023
Actual
Sample size
Target
72
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22786 0
Box Hill Hospital - Box Hill
Recruitment postcode(s) [1] 38072 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 311814 0
Hospital
Name [1] 311814 0
Eastern Health
Country [1] 311814 0
Australia
Primary sponsor type
Hospital
Name
Eastern Health
Address
8 Arnold St Box Hill VIC, 3128
Country
Australia
Secondary sponsor category [1] 313290 0
None
Name [1] 313290 0
Not applicable
Address [1] 313290 0
Not applicable
Country [1] 313290 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311261 0
Eastern Health HREC
Ethics committee address [1] 311261 0
Ethics committee country [1] 311261 0
Australia
Date submitted for ethics approval [1] 311261 0
12/04/2022
Approval date [1] 311261 0
04/07/2022
Ethics approval number [1] 311261 0

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

Contacts
Principal investigator
Name 120486 0
Dr Amy Dennett
Address 120486 0
Eastern Health
Level 2, 5 Arnold St
Box Hill VIC 3128
Country 120486 0
Australia
Phone 120486 0
+61 390952442
Fax 120486 0
Email 120486 0
[email protected]
Contact person for public queries
Name 120487 0
Amy Dennett
Address 120487 0
Eastern Health
Level 2, 5 Arnold St
Box Hill VIC 3128
Country 120487 0
Australia
Phone 120487 0
+61 390952442
Fax 120487 0
Email 120487 0
[email protected]
Contact person for scientific queries
Name 120488 0
Amy Dennett
Address 120488 0
Eastern Health
Level 2, 5 Arnold St
Box Hill VIC 3128
Country 120488 0
Australia
Phone 120488 0
+61 390952442
Fax 120488 0
Email 120488 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.