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Trial registered on ANZCTR
Registration number
ACTRN12625000164493
Ethics application status
Approved
Date submitted
13/01/2025
Date registered
12/02/2025
Date last updated
12/02/2025
Date data sharing statement initially provided
12/02/2025
Type of registration
Retrospectively registered
Titles & IDs
Public title
Falls Risk prevention in older persons with blood cancer (Stepping On Project)
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Scientific title
Examining the feasibility of a multifaceted falls prevention program for older people with haematological cancer: a mixed methods study
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Secondary ID [1]
313691
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X24-0372
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Accidental Falls
336268
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Blood cancer
336468
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Condition category
Condition code
Cancer
332985
332985
0
0
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Leukaemia - Acute leukaemia
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Cancer
332983
332983
0
0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Injuries and Accidents
332813
332813
0
0
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Other injuries and accidents
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Cancer
332988
332988
0
0
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Myeloma
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Cancer
332984
332984
0
0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
332986
332986
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0
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Leukaemia - Chronic leukaemia
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
This study, specifically for older patients with hematological cancer, will incorporate cancer-specific experts in the education sessions of the Stepping On Program.
The 7-week Stepping On program is a free program that includes 2-hour attendance each week and a 2-hour booster session 2-months after completion of week 7. Attendance is face-to-face in groups up to 14. The first hour focuses on gentle, balance and leg strengthening exercises including sitting knee strengthening, standing side hip strengthening, calf raises, sideways walk, heel toe walking, and sit to stand exercises. The second hour on specialist education session from experts on topics that are known to have an impact on falls risk in older people (road safety officer, a physiotherapist, a dietitian, a podiatrist, a pharmacist, and an occupational therapist). The education sessions will cover topics such as: benefits of exercise and moving about safely; home fall hazards; community safety and footwear; vision, vitamins and transport safety; and medication management. Where appropriate, cancer-specific experts will provide the specialist education sessions (e.g., diet, and managing medications).
Weekly feedback and attendance will be recorded.
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Intervention code [1]
330285
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Prevention
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Patient-rated program evaluation
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Assessment method [1]
340344
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Study-specific questionnaire with items covering met needs, opportunity to ask questions, confidence to implement learnings, rated on a Likert scale. Items are scored and summed to produce an overall program evaluation score.
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Timepoint [1]
340344
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Weekly for 7 weeks, and at 2-month booster session delivered 16 weeks following enrolment.
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Primary outcome [2]
340343
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Program feasibility
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Assessment method [2]
340343
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Study-specific attendance logs
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Timepoint [2]
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Weekly for 7 weeks, and at 2-month booster session delivered 16 weeks following enrolment.
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Primary outcome [3]
340345
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Patient experience
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Assessment method [3]
340345
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semi-structured patient interviews
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Timepoint [3]
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Immediately post-program completion.
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Secondary outcome [1]
443738
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Stepping On: Leg strength and balance assessment (assessed as a composite outcome)
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Assessment method [1]
443738
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Clinician-completed form recording the assessment of participants' performance of the following three tasks: Timed Up and Go test - time taken stand from chair, walk 3-m, turn, walk back to chair and sit down. Sit-to-stand test - time to fully sit and stand five times Tandem stance - length of time able to stand heel to toe with eyes shut.
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Timepoint [1]
443738
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Sessions 1, 7 and at 2-month booster session delivered 16 weeks following enrolment.
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Secondary outcome [2]
443739
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Presenter-rated program evaluation (assessed as a composite outcome including feasibility, and suggestions for improvement)
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Assessment method [2]
443739
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Semi-structured interviews with education session presenters.
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Timepoint [2]
443739
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Immediately post-program completion
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Eligibility
Key inclusion criteria
- Diagnosed with any type of hematological cancer
- Currently receiving/or have completed treatment for hematological cancer within the last 12 months
- Aged 65 or older (45 or older for Aboriginal or Torres Strait Islander adults)
- Living independently in the community or retirement village
- Able to walk safely within their home without a walking frame
- Able to provide informed consent
- Able to speak conversational English
- Considered to be at risk of falling by their hematologist
- Have been notified of the study by their hematologist
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- not treated for hematological cancer within last 12-months
- <65 years old
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
17/01/2025
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Date of last participant enrolment
Anticipated
25/04/2025
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Actual
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Date of last data collection
Anticipated
27/06/2025
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Actual
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Sample size
Target
28
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Accrual to date
12
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
27481
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Concord Repatriation Hospital - Concord
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Recruitment hospital [2]
27482
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Royal Prince Alfred Hospital - Camperdown
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Recruitment postcode(s) [1]
43590
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2139 - Concord
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Recruitment postcode(s) [2]
43591
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2050 - Camperdown
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Funding & Sponsors
Funding source category [1]
318157
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Government body
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Name [1]
318157
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SLHD Cancer and Palliative Care/CINSW Clinical Trials Grant
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Address [1]
318157
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Country [1]
318157
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Australia
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Primary sponsor type
Government body
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Name
Sydney Local Health District
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Address
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Country
Australia
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Secondary sponsor category [1]
320540
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None
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Name [1]
320540
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Address [1]
320540
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Country [1]
320540
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316803
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Sydney Local Health District Ethics Review Committee (RPAH Zone)
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Ethics committee address [1]
316803
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https://www.slhd.nsw.gov.au/rpa/research/
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Ethics committee country [1]
316803
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Australia
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Date submitted for ethics approval [1]
316803
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31/10/2024
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Approval date [1]
316803
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11/12/2024
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Ethics approval number [1]
316803
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X24-0372 & 2024/ETH02485
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Summary
Brief summary
This study aims to assess the feasibility of delivering a caner-specific Stepping On program for older individuals who have recently completed or are receiving treatment for hematological cancer. Who is it for? You may be eligible to join this study if you are aged 65 years and older (45 years or older if you identify as Aboriginal or Torres Strait Islander). You are either currently undergoing or have recently completed treatment for hematological cancer and who are considered by their hematologist to be suitable to participate in the Stepping On program will be invited to participate. Study details All participants who meet the eligibility criteria in this study will undertake the 7-week Stepping On program that includes 2-hour attendance each week and a 2-hour booster session 2-months after completion of week 7. During and after the program you will be assessed for patient experience, leg strength and balance, program attendance and program related evaluation. It is hoped that this research project will assess whether the Stepping On program can be adapted for the specific needs of older adults receiving treatment for a blood cancer.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
139058
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Prof Kate White
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Address
139058
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Cancer Care Research Unit, Level 6-North, Chris O'Brien Lifehouse (c39z), University of Sydney, NSW 2006
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Country
139058
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Australia
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Phone
139058
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+61 2 8627 1567
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Fax
139058
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Email
139058
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[email protected]
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Contact person for public queries
Name
139059
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Dr Bora Kim
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Address
139059
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Cancer Care Research Unit, Level 6-North, Chris O'Brien Lifehouse (c39z), University of Sydney, NSW 2006
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Country
139059
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Australia
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Phone
139059
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+61 2 8627 1523
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Fax
139059
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Email
139059
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[email protected]
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Contact person for scientific queries
Name
139060
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Dr Bora Kim
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Address
139060
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Cancer Care Research Unit, Level 6-North, Chris O'Brien Lifehouse (c39z), University of Sydney, NSW 2006
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Country
139060
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Australia
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Phone
139060
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+61 2 8627 1523
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Fax
139060
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Email
139060
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
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.
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