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Trial registered on ANZCTR


Registration number
ACTRN12619000194167
Ethics application status
Approved
Date submitted
29/01/2019
Date registered
12/02/2019
Date last updated
12/02/2019
Date data sharing statement initially provided
12/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of wearing an activity tracker on the length of hospital stay for gastrointestinal cancer patients: A randomised controlled trial (the Fit-4-Home Trial)
Scientific title
The effect of a wearable activity tracker on the length of hospital stay for gastrointestinal cancer patients: A randomised controlled trial (the Fit-4-Home Trial)
Secondary ID [1] 297232 0
none
Universal Trial Number (UTN)
Trial acronym
Fit-4-Home Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal Cancer 311294 0
Condition category
Condition code
Cancer 309915 309915 0 0
Liver
Cancer 309916 309916 0 0
Stomach
Cancer 309917 309917 0 0
Pancreatic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will first complete a baseline questionnaire when they consent to the trial, and provide some personal details and medical history to the study research officer. They will then proceed to their surgery, Participants will given a wearable "Fitbit(TM)" activity tracker to wear throughout their hospital stay, will be verbally encouraged to mobilise (walk around) on the ward by the physiotherapists and will record their daily steps in a log/diary while in hospital. At discharge, the activity tracker will be returned to the research officer.
After surgery, intervention participants will complete another 2 post-operative questionnaire at time of discharge from hospital and 30 days after surgery.

The control (comparator) group will undergo all these procedures except they will NOT wear an activity tracker during their hospital stay.
Intervention code [1] 313485 0
Treatment: Other
Comparator / control treatment
Participants in the control group will first complete a baseline questionnaire when they consent to the trial, and provide some personal details and medical history to the study research officer. They will then proceed to their surgery, Participants will be verbally encouraged to mobilise (walk around) on the ward by the physiotherapists and will record their daily steps in a log/diary while in hospital. Control participants will not be given an activity tracker.
After surgery, control participants will complete another 2 post-operative questionnaire at time of discharge from hospital and 30 days after surgery.
Control group
Active

Outcomes
Primary outcome [1] 318852 0
To assess if wearing an activity tracker during the inpatient stay impacts the length of hospital stay (defined as the duration of inpatient hospital stay (in days) from admission to the ward (day 0) until hospital discharge, data obtained from patient hospital records).
Timepoint [1] 318852 0
Time of discharge from hospital.
Secondary outcome [1] 366245 0
To assess if wearing an activity tracker during inpatient stay impacts on self-reported physical activity, as measured using the International Physical Activity Questionnaire-Short Form (IPAQ-SF).
Timepoint [1] 366245 0
Baseline (day 0 on ward), at time of discharge from hospital and 30-days postoperative.
Secondary outcome [2] 366246 0
To assess if wearing an activity tracker during inpatient stay impacts on self-reported re-admissions to hospital or emergency department visits within 30 days postoperatively.
This will be collected/assessed by patient self-reports of hospital re-admission or emergency department visits up to 30 days postoperatively, which will be correlated to hospital records/discharge notes if available.
Timepoint [2] 366246 0
30 Days postoperatively.
Secondary outcome [3] 366247 0
To assess if wearing an activity tracker during inpatient stay impacts on patients’ discharge destination (i.e. home, rehabilitation facility, nursing facility, etc) as recorded in hospital discharge notes / hospital record.
Timepoint [3] 366247 0
Time of discharge from hospital.
Secondary outcome [4] 366250 0
To assess if wearing an activity tracker during inpatient stay impacts on in-hospital complication rates (defined as the proportion of patients developing one or more complications according to the Clavien-Dindo classification) as recorded in participants' electronic medical records.
Timepoint [4] 366250 0
At time of discharge from hospital.
Secondary outcome [5] 366251 0
To assess if wearing an activity tracker during inpatient stay impacts on patient self-reported quality of life, as assessed by the Short Form 36 version 2 (SF-36) questionnaire.
Timepoint [5] 366251 0
Baseline (day 0 on hospital ward) and at time of discharge from hospital.
Secondary outcome [6] 366253 0
To assess if wearing an activity tracker during inpatient stay impacts on patient self-reported pain and fatigue, as assessed with a study specific composite pain and fatigue score (based on the pain and fatigue items of the SF-36 v2 instrument)
Timepoint [6] 366253 0
Baseline (day 0 on hospital ward) and at time of discharge from hospital.
Secondary outcome [7] 366255 0
To assess if wearing an activity tracker during inpatient stay impacts on patient self-reported distress, as assessed with the Distress Thermometer instrument.
Timepoint [7] 366255 0
Baseline (day 0 on hospital ward) and at time of discharge from hospital.

Eligibility
Key inclusion criteria
Patients must be adults aged 18-80 years and scheduled to undergo elective surgery for liver, stomach and pancreatic cancer with one of the participating surgeons at the Royal Prince Alfred Hospital, Sydney.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients will be excluded from participating in this trial if they present:
• Cognitive impairment such that they are unable to provide informed consent.
• Unable to place a Fitbit on patient’s wrist (including size and/or allergy).
• Neurological deficit which requires assistance in mobilisation (e.g. stroke, post limb amputation).
• Insufficient English language to complete outcome measures

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)
An experienced clinical trialist not involved in the trial will prepare the group allocation after written informed consent and baseline assessment are obtained from the participant. Consecutively numbered, sealed, opaque envelopes containing group allocation will be prepared by a clinical trialist not involved in the trial. The concealed envelopes will be stored in a locked cabinet and will be opened in sequence to reveal group allocation by a clinical trialist not involved in the recruitment process, treatment, or assessment of outcomes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be carried out using a computer based, random-sequence generator, stratified by surgical procedure (liver, pancreatic and stomach cancer surgery).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Randomisation will be carried out on a 1:1 basis and will utilise a computer based, random-sequence generator, stratified by surgical procedure (liver, pancreatic and stomach cancer surgery). Variable-sized blocks will be used to ensure approximately equal numbers in the two trial arms. Patients will be randomised to the intervention (wearing an activity tracker) or the control group (not wearing an activity tracker).
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Descriptive statistics will be used to summarise baseline patient characteristics and postoperative outcomes. The primary outcome of the study, to determine the effectiveness of a wearable activity tracker compared to control (no wearable activity tracker) on length of hospital stay, the two sample independent t test (normally distributed data) or Mann–Whitney U test (non-normally distributed data) will be used to compare the length of hospital stay (in days) between the two groups. The secondary outcomes, comparing postoperative complication rates, discharge destination, quality of life, physical activity, pain, fatigue, distress and hospital re-admission within 30 days between the two groups, will be performed using the two sample independent t test (normally distributed data) or Mann–Whitney U test (non-normally distributed data) for continuous outcomes , while chi-square test or fisher’s exact test will be used for categorical variables, adopting a 2-sided significance level of p<0.05.
Adherence to the intervention will be calculated based on the number of days the each patient achieves their assigned daily step count.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 13007 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 25491 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 301788 0
Government body
Name [1] 301788 0
Sydney Local Health District
Address [1] 301788 0
Executive Offices
Level 11, KGV Building
Missenden Road
Camperdown NSW 2050
Country [1] 301788 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Executive Offices
Level 11, KGV Building
Missenden Road
Camperdown NSW 2050
Country
Australia
Secondary sponsor category [1] 301530 0
None
Name [1] 301530 0
none
Address [1] 301530 0
none
Country [1] 301530 0
Other collaborator category [1] 280504 0
Other
Name [1] 280504 0
Surgical Outcomes Research Centre
Address [1] 280504 0
Level 9, Building 89
Royal Prince Alfred Hospital
Missenden Road
Camperdown NSW 2050

Mailing address:
PO Box M157
Missenden Road
Camperdown, NSW 2050
Country [1] 280504 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302500 0
Sydney Local Health District Research Ethics Committee (RPA Zone) [EC00113]
Ethics committee address [1] 302500 0
Research Development Office
Suite 2A,, 100 Carillon Ave
Newtown NSW 2042
Ethics committee country [1] 302500 0
Australia
Date submitted for ethics approval [1] 302500 0
19/10/2018
Approval date [1] 302500 0
24/01/2019
Ethics approval number [1] 302500 0
HREC/18/RPAH/721 and X18-0488

Summary
Brief summary
This study is intended to investigate if wearing an activity tracker during inpatient hospital stay impacts the length of inpatient stay, in days.

Who is it for?
You may be eligible for this study if you are aged at 18-80 years and are undergoing surgery for stomach, liver or pancreatic cancer with one of the participating surgeons involved in this study at the Royal Prince Alfred Hospital in Sydney.

Study details
Participants in this study will be randomised (by chance) into two groups. Both groups will undergo their planed surgery procedure. One group will then wear an activity tracker during their inpatient stay in hospital in addition to receiving the usual post operative care, while the other group will not wear an activity tracker but will also receive the usual post-operative care.. All participants will complete a number of questionnaires at 3 timepoints over the weeks just prior to and following their surgery.

It is intended that this study will help to improve post-operative care for stomach, liver and/or pancreatic cancer patients in the future.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 90426 0
Dr Daniel Steffens
Address 90426 0
Surgical Outcomes Research Centre
PO Box M157
Missenden Road
Camperdown NSW 2050
Country 90426 0
Australia
Phone 90426 0
+61 295153203
Fax 90426 0
+61295153222
Email 90426 0
Daniel.Steffens@health.nsw.gov.au
Contact person for public queries
Name 90427 0
Dr Daniel Steffens
Address 90427 0
Surgical Outcomes Research Centre
PO Box M157
Missenden Road
Camperdown NSW 2050
Country 90427 0
Australia
Phone 90427 0
+61 295153203
Fax 90427 0
+61295153222
Email 90427 0
Daniel.Steffens@health.nsw.gov.au
Contact person for scientific queries
Name 90428 0
Dr Daniel Steffens
Address 90428 0
Surgical Outcomes Research Centre
PO Box M157
Missenden Road
Camperdown NSW 2050
Country 90428 0
Australia
Phone 90428 0
+61 295153203
Fax 90428 0
+61295153222
Email 90428 0
Daniel.Steffens@health.nsw.gov.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?
De-identified individual participant data underlying published results only
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication.
Available to whom?
Only researchers who provide a methodologically sound proposal on a case-by-case basis at the discretion of Primary Sponsor and Chief investigators.
Available for what types of analyses?
Only to achieve the aims in the approved proposal.
How or where can data be obtained?
Access will be subject to approvals by Principal Investigator and approved proposals will require a signed data access agreement.
What supporting documents are/will be available?
No other documents available
Summary results
No Results