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Trial registered on ANZCTR


Registration number
ACTRN12606000228583
Ethics application status
Approved
Date submitted
16/05/2006
Date registered
6/06/2006
Date last updated
10/04/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
To evaluate the psychometric properties and user acceptability of the patient completed Peter Mac Supportive Needs Screening Tool (SNST).
Scientific title
To measure the psychometric properties of a newly developed tool for use in the ambulatory cancer care setting to help improve efficiency in identifying and planning interventions to meet the supportive care needs of cancer patients.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
All cancers 1206 0
Condition category
Condition code
Cancer 1291 1291 0 0
Other cancer types

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The design is a cross-sectional study of cancer patients attending the Peter Mac Moorabbin Campus to test construct validity, acceptability and test-retest reliability.
For the test-re-test reliability, participants will complete the Peter Mac Supportive Needs Screening Tool twice 72 hours apart. This tool takes approximately 10 minutes to complete. To evaluate construct validity patients will complete the three screening tools, the Peter Mac SNST, the SCNS and the BSI-18 presented in a random order. The completion time for the BSI 18 is 10 minutes and for the Supportive Care Needs Survey is 15 minutes. Following completion of the three tools preference questions regarding the tools will be asked.
Participants will be randomly allocated to one of two groups, group one participants will receive the Peter Mac SNST alone first and then the three tools 72 hours later and
Intervention code [1] 1047 0
Treatment: Other
Comparator / control treatment
Group two will receive the same tools, but will complete the three tools together first and then the Peter Mac Supportive Needs Screening tool 72 hours later.
Control group
Active

Outcomes
Primary outcome [1] 1757 0
To estimate the correlations between three similar instruments (Peter Mac SNST, Brief Symptom Inventory – 18 (BSI18) and the Supportive Care Needs Survey (SCNS) in their psychological domain scores
Timepoint [1] 1757 0
Participants will complete the three assessment tools at the same time either whilst on site while waiting for an appointment or at the 72 hour follow-up
Primary outcome [2] 1758 0
To estimate the correlations between two instruments (Peter Mac SNST and SCNS) in physical, sexuality and health-system and information domain scores
Timepoint [2] 1758 0
Participants will complete the three assessment tools at the same time either whilst on site while waiting for an appointment or at the 72 hour follow-up
Primary outcome [3] 1759 0
To assess the repeatability of the Peter Mac SNST instrument
Timepoint [3] 1759 0
Participants will complete the first assessment while waiting for their appointment and be asked to complete the second stage assessment at home 72 hours later.
Secondary outcome [1] 3109 0
To assess the association between each item, as well as the mean of the items, in the psychological domain of the Peter Mac SNST with the depression and anxiety scores in the BSI18.
Timepoint [1] 3109 0
Participants will complete the three assessment tools at the same time either whilst on site while waiting for an appointment or at the 72 hour follow-up.

Eligibility
Key inclusion criteria
Must be receiving treatment at Peter Mac; have a diagnosis of cancer; newly registered, within six weeks, as a Peter Mac patient; agree to data extraction from their medical record; expecting to have some ongoing treatment at Peter Mac.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Too unwell to participate; unable to complete the tools; would like a second opinion only, i.e. are not attending Peter Mac for any length of time.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by a computer
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/07/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1417 0
Government body
Name [1] 1417 0
Department of Human Services Victoria
Country [1] 1417 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Peter MacCallum Cancer Centre
Address
Locked Bag 1 A'Beckett St Melbourne 8006
Country
Australia
Secondary sponsor category [1] 1243 0
None
Name [1] 1243 0
Nil
Address [1] 1243 0
Country [1] 1243 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2773 0
Peter MacCallum Cancer Centre
Ethics committee address [1] 2773 0
Ethics committee country [1] 2773 0
Australia
Date submitted for ethics approval [1] 2773 0
Approval date [1] 2773 0
16/06/2005
Ethics approval number [1] 2773 0
E17-05

Summary
Brief summary
This project is an attempt to measure the reliability and validity of the Peter Mac Supportive Needs Screening Tool (SNST). The Peter Mac SNST was developed for use in clinical practice to facilitate a system to identify need early and a process for planning of appropriate intervention. Specifically the study aims to assess: 1) the content validity (the extent to which the tool includes the relevant domains of cancer patients’ supportive care needs); 2) the construct validity (the extent to which the tool accurately identifies supportive care needs); and 3) assess the reliability of the tool, the extent to which the tool is a consistent measure of supportive care needs. This project will look at the correlation of the answers of the anxiety and depression domain from the Peter Mac SNST with the Supportive Care Needs Survey (SCNS) and the Brief Symptom Inventory (BSI-18), two tools previously validated in the cancer population, to identify the construct validity in this domain. The construct validity of three other domains will be evaluated by comparing the matching domains of Peter Mac SNST with the SCNS. Testing the reliability of the tool within a short time frame will also be undertaken. There was no blinding as participants were aware that they were either filling in three forms whilst waiting for their appointment or were completing only one.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35529 0
Address 35529 0
Country 35529 0
Phone 35529 0
Fax 35529 0
Email 35529 0
Contact person for public queries
Name 10236 0
Cathie Pigott
Address 10236 0
Peter MacCallum Cancer Centre
Nursing Education
Level 3
Locked Bag 1
A'Beckett Street
Melbourne VIC 8006
Country 10236 0
Australia
Phone 10236 0
+61 3 96563561
Fax 10236 0
+61 3 96561337
Email 10236 0
[email protected]
Contact person for scientific queries
Name 1164 0
Cathie Pigott
Address 1164 0
Peter MacCallum Cancer Centre
Nursing Education
Level 3
Locked Bag 1
A'Beckett Street
Melbourne VIC 8006
Country 1164 0
Australia
Phone 1164 0
+61 3 96563561
Fax 1164 0
+61 3 96561337
Email 1164 0
[email protected]

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
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