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Trial registered on ANZCTR


Registration number
ACTRN12619001151123
Ethics application status
Approved
Date submitted
24/07/2019
Date registered
16/08/2019
Date last updated
16/08/2019
Date data sharing statement initially provided
16/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Steps to Recovery: a randomised trial aimed at increasing physical activity in hospitalised cancer patients
Scientific title
Steps to Recovery: Promotion of Physical Activity in Hospitalised Patients, a pilot feasibility study
Secondary ID [1] 298820 0
Nil known
Universal Trial Number (UTN)
U1111-1237-4241
Trial acronym
STR
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Deconditioning 313772 0
Hospitalised patients 313773 0
Cancer rehabilitation 313774 0
Condition category
Condition code
Physical Medicine / Rehabilitation 312177 312177 0 0
Physiotherapy
Cancer 312382 312382 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will receive daily physiotherapy review for goal setting, and education on the use of a smart watch (Samsung Galaxy S3) to monitor steps taken per day and 'active minutes' per day. Participants in the intervention group will be encouraged to check their 'smart watch' through the day, to track number of steps and 'active minutes' and assist with goal attainment. By contrast, participants in the control group will have a 'locked' watch face and be unable to view the watch face to track their activity levels.

Participants will be also be provided with written educational materials promoting physical activity, and an exercise logbook to record type and duration of exercise per day. The educational material has been produced specifically for this study, and includes images and information obtained from the Cancer Council of Australia's 'Exercise for People Living with Cancer' information booklet, and the Clinical Oncology Society of Australia (COSA) Position Statement on Exercise in Cancer Care.

An ActivPAL device will be worn by participants in both the intervention and control arms for 72 hours at the beginning of each week. The purpose of the ActivPAL is to provide an additional way of recording number of steps and activity levels, and assessing the accuracy of the smart watch data.

The intervention will be delivered daily by a physiotherapist for the duration of the inpatient admission, for up to 20 days.

The intervention will take place on the oncology and haematology wards of St Vincent's Hospital.

Goals are initially set based upon the result of the baseline number of steps and 'active minutes' obtained from the smart watch, measured over 24 hours. Participants will initially be given a goal of increasing number of steps by 20% over the following 24 hours, and to gradually increase 'active minutes' towards the COSA guidelines of 20-30 minutes per day. The daily goal will continue to consist of a 20% increase in steps, so long as this goal is achieved. If the 20% target is not achieved, the target increase will be reduced to 10%, and if this is not achieved, it will be reduced to 5%.

Minimum duration of participation is 5 days, and maximum 20 days.
Intervention code [1] 315085 0
Rehabilitation
Intervention code [2] 315086 0
Lifestyle
Intervention code [3] 315087 0
Prevention
Comparator / control treatment
Standard ward physiotherapy, which typically includes 2-3 reviews by a physiotherapist per week. The control group will wear a smart watch in order to record steps and 'active minutes', but the watch face will be covered.
Control group
Active

Outcomes
Primary outcome [1] 320810 0
Change in steps taken per day, measured by recording steps taken over serial 24 hour periods obtained from Samsung Galaxy S3 smart watch pedometer function.
Timepoint [1] 320810 0
Over the course of the inpatient admission (5-20 days)
Primary outcome [2] 320811 0
Active minutes (recorded by smart watch)
Timepoint [2] 320811 0
Over the course of the inpatient admission (5-20 days)
Secondary outcome [1] 372922 0
General Self Efficacy Scale
Timepoint [1] 372922 0
At the conclusion of the intervention
Secondary outcome [2] 372923 0
Participant satisfaction with the proposed physical activity intervention during hospitalisation, measured using a 1-7 Likert scale designed for this study, and brief interviews with participants randomised to the active group.

The interviews will be approximately 5-10 minutes in duration, are semi-structured and audio recorded.
Timepoint [2] 372923 0
At the conclusion of the intervention
Secondary outcome [3] 373882 0
Accuracy of smart watch steps data, measured by comparing smart watch readings to ActivPAL readings
Timepoint [3] 373882 0
For periods where steps are measured by both the smart watch and ActivPAL device (3 days each week)

Eligibility
Key inclusion criteria
· Adults aged 18 years and over

· Admitted to St Vincent’s Public Hospital, Sydney, under the care of an oncology or haematology team, with a cancer diagnosis (solid organ or haematological malignancy)

· Patient is located on Ward 8S (oncology) or 9S (haematology)

· Able to walk without assistance, as assessed formally by the ward physiotherapist

· Expected inpatient length of stay >5 days

· Able to provide written informed consent, and to participate and comply with study procedures
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
· Medically unfit to participate in an exercise programme, as deemed by the treating medical team

· Non-independent with transfers and/or mobility (i.e. requires assistance), as deemed by the treating ward physiotherapist

· Non-English speaking patients. Because in-depth, daily communication between participants and physiotherapist is an essential component of this study, and due to the limited budget of this pilot study, using a translator will be not be feasible.

· Individuals who have already participated in the trial (e.g. during an earlier admission to hospital)

· Bone marrow transplant recipients, due to high medical acuity and likely inability to consistently participate in the trial

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation sequence will be generated via the online randomisation generator available at www.randomization.com
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
Given this is a pilot feasibility study, a convenience cohort of 40 participants will be recruited (with 1:1 group allocation). This will ensure that sufficient data is collected upon which to assess feasibility of the proposed intervention, and to design and power a future, larger study. The chosen samples size will enable feasible recruitment at the single study site over a 12 month period, based on review of admission rates to the repsective services.

Descriptive statistics including mean, range, standard deviation and 95% confidence intervals will be used to describe the study population in terms of demography and clinical variables. Analyses of variance with factors of time and group will be used to examine the effect of the intervention on outcomes measures (including step counts, activity levels, self-efficacy, TUG scores, STS), and to investigate group-by-time interactions for any measures. Analyses will be conducted using intention-to-treat methodology. Any side effects or adverse events associated with the intervention (such as falls and/or fatigue) will be reported descriptively, as will patient satisfaction data. Statistical analyses will be conducted in SPSS software (v23, IBM), and results will be considered significance when p<0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
19/08/2019
Actual
Date of last participant enrolment
Anticipated
5/08/2020
Actual
Date of last data collection
Anticipated
10/08/2020
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 303371 0
Charities/Societies/Foundations
Name [1] 303371 0
St Vincent’s Clinic Foundation
Country [1] 303371 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
St Vincent’s Clinic Foundation
Address
St Vincent's Clinic Foundation
438 Victoria St, Darlinghurst NSW 2010
Country
Australia
Secondary sponsor category [1] 303403 0
None
Name [1] 303403 0
Nil
Address [1] 303403 0
Nil
Country [1] 303403 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303901 0
St Vincent's Hospital Human Research Ethics Committee
Ethics committee address [1] 303901 0
Ethics committee country [1] 303901 0
Australia
Date submitted for ethics approval [1] 303901 0
24/01/2019
Approval date [1] 303901 0
26/04/2019
Ethics approval number [1] 303901 0
2019/ETH00100

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

Contacts
Principal investigator
Name 95186 0
Dr Abraham Patrick Arulanandam
Address 95186 0
Sacred Heart Rehabilitation Services & St. Vincent’s Hospital Sydney
170 Darlinghurst Rd, Darlinghurst NSW 2010
Country 95186 0
Australia
Phone 95186 0
+61 2 8382 9516
Fax 95186 0
Email 95186 0
abraham.arulanandam@svha.org.au
Contact person for public queries
Name 95187 0
Abraham Patrick Arulanandam
Address 95187 0
Sacred Heart Rehabilitation Services & St. Vincent’s Hospital Sydney
170 Darlinghurst Rd, Darlinghurst NSW 2010
Country 95187 0
Australia
Phone 95187 0
+61 2 8382 9516
Fax 95187 0
Email 95187 0
abraham.arulanandam@svha.org.au
Contact person for scientific queries
Name 95188 0
Abraham Patrick Arulanandam
Address 95188 0
Sacred Heart Rehabilitation Services & St. Vincent’s Hospital Sydney
170 Darlinghurst Rd, Darlinghurst NSW 2010
Country 95188 0
Australia
Phone 95188 0
+61 2 8382 9516
Fax 95188 0
Email 95188 0
abraham.arulanandam@svha.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
To preserve patient confidentiality. Ethics approval has not been obtained to share individual participant data.


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.