Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000170527
Ethics application status
Approved
Date submitted
10/05/2006
Date registered
11/05/2006
Date last updated
11/05/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementing question prompt lists in routine clinical practice for cancer patients
Scientific title
Examining the feasibility and acceptability of implementing question prompt lists in routine clinical practice across four hospitals in NSW for cancer patients, to improve doctor-patient communication and increase patient involvement during oncology consultations
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patients referred to a medical, radiation or surgical oncologist, including for palliative care 1143 0
Condition category
Condition code
Cancer 1223 1223 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Provision of a question prompt list (QPL) to cancer patients (new and follow-up), the implementation method of which is to be negotiated with each individual cancer center. May include (i) receptionist offers QPL upon arrival to center, (ii) QPL sent out to patients prior to consultation, (iii) the participating doctor will offer the QPL in consultation, or (iv) the clinical care co-ordinator will offer the QPL at surgical discharge or initial medical oncology consultation. Implementation at each cancer center will be monitored for a period of 4-6 weeks (total period of data collection = approx. 6 months)
Intervention code [1] 1032 0
Other interventions
Comparator / control treatment
No comparator.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 1658 0
Uptake rate of QPL by doctors
Timepoint [1] 1658 0
Primary outcome [2] 1659 0
Uptake rate of QPL by patients
Timepoint [2] 1659 0
Secondary outcome [1] 2961 0
Doctor perceived utility of QPL prior to trial
Timepoint [1] 2961 0
Secondary outcome [2] 2962 0
Consultation duration before and during the trial
Timepoint [2] 2962 0
Secondary outcome [3] 2963 0
Cost of services
Timepoint [3] 2963 0
Secondary outcome [4] 2964 0
Patient satisfaction with QPL and consultation
Timepoint [4] 2964 0
Secondary outcome [5] 2965 0
Doctor satisfaction with implementation method and utility of QPL
Timepoint [5] 2965 0

Eligibility
Key inclusion criteria
1. Seeing a medical/radiation/surgical oncologist in a participating cancer center; 2. Well enough to read QPL and to participate in follow-up surveys.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria

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
Single group
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1335 0
Other
Name [1] 1335 0
Cancer Institute NSW
Country [1] 1335 0
Australia
Primary sponsor type
University
Name
Medical Psychology Research Unit, University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 1178 0
None
Name [1] 1178 0
Nil
Address [1] 1178 0
Country [1] 1178 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2684 0
Sydney University
Ethics committee address [1] 2684 0
Ethics committee country [1] 2684 0
Australia
Date submitted for ethics approval [1] 2684 0
Approval date [1] 2684 0
06/04/2006
Ethics approval number [1] 2684 0
03-2006/1/8860

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

Contacts
Principal investigator
Name 35179 0
Address 35179 0
Country 35179 0
Phone 35179 0
Fax 35179 0
Email 35179 0
Contact person for public queries
Name 10221 0
Dr Aneta Dimoska
Address 10221 0
Medical Psychology Research Unit
Faculty of Medicine, Room 110
Blackburn Building D06
University of Sydney NSW 2006
Country 10221 0
Australia
Phone 10221 0
+61 2 9036 5381
Fax 10221 0
+61 2 9036 5420
Email 10221 0
[email protected]
Contact person for scientific queries
Name 1149 0
Professor Martin Tattersall
Address 1149 0
Department of Cancer Medicine
Faculty of Medicine Room 381
Blackburn Building (D06)
University of Sydney NSW 2006
Country 1149 0
Australia
Phone 1149 0
+61 2 9515 8953
Fax 1149 0
+61 2 9351 4317
Email 1149 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.