Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000284268p
Ethics application status
Submitted, not yet approved
Date submitted
8/02/2018
Date registered
23/02/2018
Date last updated
21/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of the electronic Rapid Fitness Assessment in older adults with cancer at an Australian Regional Cancer Centre
Scientific title
Feasibility of the electronic Rapid Fitness Assessment (eRFA) in older adults with cancer in an Australian regional cancer centre.
Secondary ID [1] 293987 0
None
Universal Trial Number (UTN)
U1111-1209-0797
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer in older adults 306501 0
Condition category
Condition code
Cancer 305611 305611 0 0
Any cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The electronic Rapid Fitness Assessment (eRFA) is a set of seven previously validated geriatric assessment and screening tools that can be used to determine the need for a comprehensive geriatric assessment and guide service provision.
The eRFA is a web-based questionnaire that is mostly self assessed but also contains two tests to be performed by a clinician: the Timed Up and Go (TUG) and the Mini-COG. The TUG and Mini-COG will be administered by a research nurse or medical oncologist.
The eRFA measures major domains of geriatric assessment (e.g. activities of daily living (ADLs), instrumental activities of daily living (IADLs), depression, nutritional status, social support status, polypharmacy) while patients are waiting for their appointment with the medical oncologist. The questionnaire involves 21 questions and takes between 10 and 15 minutes to complete.
The eRFA (including the TUG and MiniCOG) will be administered on one occasion only, prior to the first appointment with the oncologist.
Intervention code [1] 300265 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304729 0
Feasibility of the eRFA in a regional cancer clinic as a composite endpoint will be evaluated by the number of patients who complete the eRFA, the number of questions completed and patient satisfaction with the survey.
Administering the eRFA in the oncology clinic will be considered feasible if:
a. At least 80% of eligible patient-clinic visit data is collected. AND
b. At least 75% of questions are answered by patients in the waiting area. AND
c. At least 70% of patients rate eRFA as easy or very easy to use.
Timepoint [1] 304729 0
Feasibility will be assessed at the completion of enrolment (ie after 50 patients)
The data will be collected at baseline only.
Secondary outcome [1] 343316 0
Level of social support using the 4 item
Medical Outcomes Study - Social Satisfaction Survey (MOS-SSS scale)
Timepoint [1] 343316 0
Baseline
Secondary outcome [2] 343318 0
Emotional status/level of distress
Using the Distress thermometer
Timepoint [2] 343318 0
Baseline
Secondary outcome [3] 343320 0
Level of polypharmacy
Patient reported - eRFA question
Number of prescribed medicines
Number of supplements, vitamins and over the counter medicines
Timepoint [3] 343320 0
Baseline
Secondary outcome [4] 343315 0
Presence of hearing impairment
Question in eRFA - 4 point scale
How is your hearing?
Excellent, Good, Fair or Poor.
Timepoint [4] 343315 0
Baseline
Secondary outcome [5] 342944 0
Performance status of the patients (Karnofsky scale)
Timepoint [5] 342944 0
Baseline
Secondary outcome [6] 343317 0
Level of Social activity interference using the Medical Outcomes Study Social Activity Survey
(MOS-SAS scale)
Timepoint [6] 343317 0
Baseline
Secondary outcome [7] 343322 0
Number of patients with cognitive impairment
Screened for using the Mini-COG test.
Timepoint [7] 343322 0
Baseline.
Secondary outcome [8] 343314 0
Presence of visual impairment
Question in eRFA - 4 point scale
How is your vision?
Excellent, Good, Fair or Poor.
Timepoint [8] 343314 0
Baseline
Secondary outcome [9] 343079 0
Instrumental activities of daily living (IADLs)
Lawton index
Timepoint [9] 343079 0
Baseline
Secondary outcome [10] 343078 0
Basic activities of daily living (ADLs)
Katz scale
Timepoint [10] 343078 0
Baseline
Secondary outcome [11] 343323 0
Number of referrals made for supportive care interventions as a result of the eRFA..
Data collection
Clinician input
Timepoint [11] 343323 0
Baseline
Secondary outcome [12] 343319 0
Level of depression
using the Geriatric depression scale (4 item)
Timepoint [12] 343319 0
Baseline
Secondary outcome [13] 343321 0
Assessment of physical function
using the Timed up and Go test (TUG)
Timepoint [13] 343321 0
Baseline

Eligibility
Key inclusion criteria
1. Patients referred for an opinion at Border Medical Oncology clinic (outpatient/ambulatory service)
2. Age 70 years or older.
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients assessed as an inpatient as the first appointment with a BMO oncologist

Study design
Purpose of the study
Treatment
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
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/05/2018
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 9986 0
Border Medical Oncology - Albury
Recruitment postcode(s) [1] 18826 0
2640 - Albury

Funding & Sponsors
Funding source category [1] 298617 0
Charities/Societies/Foundations
Name [1] 298617 0
Albury Wodonga Regional Cancer Centre Trust
Country [1] 298617 0
Australia
Primary sponsor type
Other
Name
Border Medical Oncology Research Unit
Address
Level 1, AWRCC
201-239 Borella Road, Albury, NSW 2640
Country
Australia
Secondary sponsor category [1] 297781 0
None
Name [1] 297781 0
Address [1] 297781 0
Country [1] 297781 0
Other collaborator category [1] 279930 0
Other
Name [1] 279930 0
Web Survey Core
Address [1] 279930 0
Memorial Sloan Kettering Cancer Center
1275 York Avenue
New York, NY 10065
Country [1] 279930 0
United States of America

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 299578 0
The Albury Wodonga Human Research Ethics Committee (AWHREC)
Ethics committee address [1] 299578 0
Ethics committee country [1] 299578 0
Australia
Date submitted for ethics approval [1] 299578 0
14/02/2018
Approval date [1] 299578 0
Ethics approval number [1] 299578 0

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

Contacts
Principal investigator
Name 80898 0
Dr Christopher Steer
Address 80898 0
Border Medical Oncology
Level 1, AWRCC
201-239 Borella Road,
Albury, NSW 2640
Country 80898 0
Australia
Phone 80898 0
+61260641504
Fax 80898 0
Email 80898 0
csteer@bordermedonc.com.au
Contact person for public queries
Name 80899 0
Christine Packer
Address 80899 0
Border Medical Oncology Research Unit
Albury Wodonga Regional Cancer Centre
Level 1, 201-239 Borella Road, Albury, NSW, 2640

Postal Address:
PO BOX 7246, Albury, NSW, 2640
Country 80899 0
Australia
Phone 80899 0
+61 2 6064 1504
Fax 80899 0
+61 2 6064 1501
Email 80899 0
cpacker@bordermedonc.com.au
Contact person for scientific queries
Name 80900 0
Christopher Steer
Address 80900 0
Border Medical Oncology Research Unit
Albury Wodonga Regional Cancer Centre
Level 1, 201-239 Borella Road, Albury, NSW, 2640

Postal Address:
PO BOX 7246, Albury, NSW, 2640
Country 80900 0
Australia
Phone 80900 0
+61260641504
Fax 80900 0
Email 80900 0
csteer@bordermedonc.com.au

No information has been provided regarding IPD availability


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.