Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000107224
Ethics application status
Approved
Date submitted
9/12/2008
Date registered
16/02/2009
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
It's okay to ask: pilot evaluation of a tool to facilitate information exchange for adults with brain tumours
Scientific title
Does provision of a brain tumour-specific question prompt list improve information exchange for adults diagnosed with a primary brain tumour in Queensland?
Secondary ID [1] 263051 0
No secondary ID
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Brain tumour 4101 0
Information exchange 4102 0
Condition category
Condition code
Cancer 4296 4296 0 0
Brain

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Provision of a brain tumour-specific question prompt list (QPL) within two weeks of first neurosurgical consultation. The QPL provides patients with a list of questions which have been useful to previous patients. It aims to assist individuals to actively participate in their clinical consultations through
asking proposed questions of healthcare providers. The QPL is thus designed to provide a framework within
which patients and carers can organise their information needs and follow pathways to obtain desired information at the preferred level. That is, the QPL prompts patients to ask relevant questions of their health care providers. The QPL will be given to participants immediately following the first data collection interview by the researcher.
Intervention code [1] 3812 0
Behaviour
Comparator / control treatment
Standard information brochure "About brain tumours" produced The Cancer Council Queensland. Headings in the brochure are, 'Understanding your brain tumour', 'What to expect', 'Lobe of the brain', 'Suggestions for coping', 'Brain Tumour Support Service' and 'How to find out more'. As with the QPL, this will be given to participants immediately following the first data collection interview by the researcher.
Control group
Active

Outcomes
Primary outcome [1] 5437 0
Information received, assessed by the European Organization for Research and Treatment of Cancer (EORTC QLQ-30) INFO module
Timepoint [1] 5437 0
At baseline and 1 month after trial commencement.
Secondary outcome [1] 9135 0
Qualitative data regarding acceptability and use of intervention.
Timepoint [1] 9135 0
1 month after trial commencement

Eligibility
Key inclusion criteria
Diagnosed with a primary brain tumour and attended initial neurosurgical consultation with selected neurosurgeons in the last 2 weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Unable to speak/read English well enough to participate.
Not well enough to participate (screened by neurosurgical staff).

Study design
Purpose of the study
Educational / counselling / training
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
Other
Other design features
First 15 participants will receive standard care; next 15 receive intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
23/11/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 1344 0
4000

Funding & Sponsors
Funding source category [1] 4263 0
University
Name [1] 4263 0
Queensland University of Technology
Country [1] 4263 0
Australia
Primary sponsor type
University
Name
Queensland University of Technology
Address
School of Public Health,
Queensland University of Technology,
Victoria Park Rd,
Kelvin Grove, Queensland, 4059
Country
Australia
Secondary sponsor category [1] 3835 0
None
Name [1] 3835 0
Address [1] 3835 0
Country [1] 3835 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6313 0
Queensland University of Technology UHREC
Ethics committee address [1] 6313 0
Victoria Park Rd,
Kelvin Grove Qld 4059
Ethics committee country [1] 6313 0
Australia
Date submitted for ethics approval [1] 6313 0
Approval date [1] 6313 0
16/09/2008
Ethics approval number [1] 6313 0
0800000549
Ethics committee name [2] 6314 0
UnitingCare Health HREC
Ethics committee address [2] 6314 0
PO Box 499
Toowong Q 4066
Ethics committee country [2] 6314 0
Australia
Date submitted for ethics approval [2] 6314 0
Approval date [2] 6314 0
15/10/2008
Ethics approval number [2] 6314 0
200841

Summary
Brief summary
This study looks at the effectiveness of a communication tool called ‘It's okay to ask’ in facilitating information exchange for adults with brain tumours.

Who is it for?
You can join this study if you:
1. live in Queensland
2. have been diagnosed with a primary brain tumour
3. have attended initial consultation with selected neurosurgeons in the last 2 weeks.

Trial details
A question prompt list (QPL) is a structured list of questions for a patient or their carer to ask a doctor if they want to. It is designed to encourage participants to ask questions in the medical consultation, empowering them to seek answers to important questions, and enabling them to share personalised information.

Work is underway to develop a QPL specifically for adults diagnosed with a primary brain tumour and their caregivers. This pilot study aims to determine:
1. if the QPL is acceptable to participants
2. if and how participants use it
3. the requirements for implementing the QPL
4. how well it works in improving information exchange.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35022 0
Address 35022 0
Country 35022 0
Phone 35022 0
Fax 35022 0
Email 35022 0
Contact person for public queries
Name 12369 0
Danette Langbecker
Address 12369 0
School of Public Health, QUT
Victoria Park Rd
Kelvin Grove QLD 4059
Country 12369 0
Australia
Phone 12369 0
+61 7 3138 6123
Fax 12369 0
Email 12369 0
[email protected]
Contact person for scientific queries
Name 3297 0
Danette Langbecker
Address 3297 0
School of Public Health, QUT
Victoria Park Rd
Kelvin Grove QLD 4059
Country 3297 0
Australia
Phone 3297 0
+61 7 3138 6123
Fax 3297 0
Email 3297 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
No additional documents have been identified.