Trial Review

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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)
Scientific title
Examining the feasibility of a multifaceted falls prevention program for older people with haematological cancer: a mixed methods study
Secondary ID [1] 313691 0
X24-0372
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Accidental Falls 336268 0
Blood cancer 336468 0
Condition category
Condition code
Cancer 332985 332985 0 0
Leukaemia - Acute leukaemia
Cancer 332983 332983 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Injuries and Accidents 332813 332813 0 0
Other injuries and accidents
Cancer 332988 332988 0 0
Myeloma
Cancer 332984 332984 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 332986 332986 0 0
Leukaemia - Chronic leukaemia

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 330285 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 340344 0
Patient-rated program evaluation
Timepoint [1] 340344 0
Weekly for 7 weeks, and at 2-month booster session delivered 16 weeks following enrolment.
Primary outcome [2] 340343 0
Program feasibility
Timepoint [2] 340343 0
Weekly for 7 weeks, and at 2-month booster session delivered 16 weeks following enrolment.
Primary outcome [3] 340345 0
Patient experience
Timepoint [3] 340345 0
Immediately post-program completion.
Secondary outcome [1] 443738 0
Stepping On: Leg strength and balance assessment (assessed as a composite outcome)
Timepoint [1] 443738 0
Sessions 1, 7 and at 2-month booster session delivered 16 weeks following enrolment.
Secondary outcome [2] 443739 0
Presenter-rated program evaluation (assessed as a composite outcome including feasibility, and suggestions for improvement)
Timepoint [2] 443739 0
Immediately post-program completion

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
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- not treated for hematological cancer within last 12-months
- <65 years old

Study design
Purpose of the study
Prevention
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
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/01/2025
Date of last participant enrolment
Anticipated
25/04/2025
Actual
Date of last data collection
Anticipated
27/06/2025
Actual
Sample size
Target
28
Accrual to date
12
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 27481 0
Concord Repatriation Hospital - Concord
Recruitment hospital [2] 27482 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 43590 0
2139 - Concord
Recruitment postcode(s) [2] 43591 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 318157 0
Government body
Name [1] 318157 0
SLHD Cancer and Palliative Care/CINSW Clinical Trials Grant
Country [1] 318157 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 320540 0
None
Name [1] 320540 0
Address [1] 320540 0
Country [1] 320540 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316803 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 316803 0
Ethics committee country [1] 316803 0
Australia
Date submitted for ethics approval [1] 316803 0
31/10/2024
Approval date [1] 316803 0
11/12/2024
Ethics approval number [1] 316803 0
X24-0372 & 2024/ETH02485

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

Contacts
Principal investigator
Name 139058 0
Prof Kate White
Address 139058 0
Cancer Care Research Unit, Level 6-North, Chris O'Brien Lifehouse (c39z), University of Sydney, NSW 2006
Country 139058 0
Australia
Phone 139058 0
+61 2 8627 1567
Fax 139058 0
Email 139058 0
[email protected]
Contact person for public queries
Name 139059 0
Dr Bora Kim
Address 139059 0
Cancer Care Research Unit, Level 6-North, Chris O'Brien Lifehouse (c39z), University of Sydney, NSW 2006
Country 139059 0
Australia
Phone 139059 0
+61 2 8627 1523
Fax 139059 0
Email 139059 0
[email protected]
Contact person for scientific queries
Name 139060 0
Dr Bora Kim
Address 139060 0
Cancer Care Research Unit, Level 6-North, Chris O'Brien Lifehouse (c39z), University of Sydney, NSW 2006
Country 139060 0
Australia
Phone 139060 0
+61 2 8627 1523
Fax 139060 0
Email 139060 0
[email protected]

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.