Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000214538
Ethics application status
Approved
Date submitted
29/05/2006
Date registered
31/05/2006
Date last updated
31/05/2006
Type of registration
Prospectively registered

Titles & IDs
Public title
Clinical trial question prompt list.
Scientific title
Enhancing cancer patient participation when discussing clinical trial enrolment: evaluation of a question prompt list.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer (any type) 1192 0
Condition category
Condition code
Cancer 1277 1277 0 0

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Patients will be randomised to receive a question prompt list to use when discussing clinical trial participation with their treating clinician. The Question Prompt List is a series of example questions that patients might like to ask, to gain a better understanding of the clinical trial and help them make an informed decision about participating. Those patients who receive the list will be given a few minutes to review its content. Both the patient and the clinician will then refer to it during their discussion about participating in a clinical trial.
Intervention code [1] 1027 0
None
Comparator / control treatment
Patients will be randomised to not receive a question prompt list to use when discussing clinical trial participation with their treating clinician. For those patients who do not receive the prompt list, the subsequent recruitment discussion will proceed in the usual manner.
Control group
Active

Outcomes
Primary outcome [1] 1726 0
Patient quality of understanding of clinical trial information
Timepoint [1] 1726 0
Measured within 3 weeks of the patient making a decision about clinical trial participation
Secondary outcome [1] 3079 0
1) Achievement of patient information/involvement preferences
Timepoint [1] 3079 0
Measured in a follow-up questionnaire within 3 weeks of the patient making a decision about participating in the clinical trial they were offered.
Secondary outcome [2] 3080 0
2) Patient satisfaction with the informed consent and decision making process.
Timepoint [2] 3080 0
Measured in a follow-up questionnaire within 3 weeks of the patient making a decision about participating in the clinical trial they were offered.
Secondary outcome [3] 3081 0
3) Clinician satisfaction with the informed consent process.
Timepoint [3] 3081 0
Measured in a follow-up questionnaire within 3 weeks of the patient making a decision about participating in the clinical trial they were offered.

Eligibility
Key inclusion criteria
Confirmed diagnosis of cancer (any type), who are eligible to be invited to take part in Phase 3 randomised cancer clinical trial at Peter MacCallum Cancer Centre, can read/speak English.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Psychological/cognitive disorder, too sick as advised by treating doctor.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Centrally randomised opaque envelopes will be distributed to each site and used to conceal allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A centralised, computer-generated randomisation procedure will be used.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
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
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1397 0
Charities/Societies/Foundations
Name [1] 1397 0
The Cancer Council Victoria
Country [1] 1397 0
Australia
Funding source category [2] 1398 0
Charities/Societies/Foundations
Name [2] 1398 0
The Cancer Council NSW
Country [2] 1398 0
Australia
Funding source category [3] 1399 0
Charities/Societies/Foundations
Name [3] 1399 0
The Cancer Council SA
Country [3] 1399 0
Australia
Primary sponsor type
Hospital
Name
Royal Prince Alfred Hospital, Peter MacCallum Cancer Centre, Royal Adelaide Hospital
Address
Country
Australia
Secondary sponsor category [1] 1229 0
None
Name [1] 1229 0
None
Address [1] 1229 0
Country [1] 1229 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2749 0
Royal Prince Alfred Hospital
Ethics committee address [1] 2749 0
Ethics committee country [1] 2749 0
Australia
Date submitted for ethics approval [1] 2749 0
Approval date [1] 2749 0
Ethics approval number [1] 2749 0
X06-0045
Ethics committee name [2] 2750 0
Peter MacCallum Cancer Centre
Ethics committee address [2] 2750 0
Ethics committee country [2] 2750 0
Australia
Date submitted for ethics approval [2] 2750 0
Approval date [2] 2750 0
Ethics approval number [2] 2750 0
06/22
Ethics committee name [3] 2751 0
Royal Adelaide Hospital
Ethics committee address [3] 2751 0
Ethics committee country [3] 2751 0
Australia
Date submitted for ethics approval [3] 2751 0
Approval date [3] 2751 0
Ethics approval number [3] 2751 0

Summary
Brief summary
Provision and use of a question prompt list by patients during a consultation increases question asking, reduces anxiety and improves recall. Previous work on question prompt sheets has found that when patients ask more questions, they gain a better understanding of the topic and satisfied with their treatment decisions. Medical staff also tend to be more satisfied with the consent process when patient’s display a better understanding of the discussion.

A Question Prompt List has been developed for patients to facilitate patient participation in clinical trial consent discussions. This project aims to examine patient attitudes to clinical trials and to investigate the effects of promoting question asking when people with cancer are asked to consider entering a randomised clinical trial.

The question prompt list will be evaluated by comparing results for the control and intervention groups on understanding of clinical trial information, satisfaction with the consent process and decision-making about trial participation and achievement of their information and involvement preference. It is expected that those patients receiving the question prompt list will have a higher mean knowledge score in the informed consent questionnaire, have enhanced achievement of their information and involvement preference and be more satisfied with the informed consent and the decision making process.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35603 0
Address 35603 0
Country 35603 0
Phone 35603 0
Fax 35603 0
Email 35603 0
Contact person for public queries
Name 10216 0
Martin Tattersall
Address 10216 0
Department of Cancer Medicine
University of Sydney
Blackburn Buiilding
DO6 Room 381
Camperdown NSW 2006
Country 10216 0
Australia
Phone 10216 0
+61 2 93513675
Fax 10216 0
Email 10216 0
[email protected]
Contact person for scientific queries
Name 1144 0
Martin Tattersall
Address 1144 0
Department of Cancer Medicine
University of Sydney
Blackburn Buiilding
DO6 Room 381
Camperdown NSW 2006
Country 1144 0
Australia
Phone 1144 0
+61 2 93513675
Fax 1144 0
Email 1144 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
SourceTitleYear of PublicationDOI
EmbaseParallel multicentre randomised trial of a clinical trial question prompt list in patients considering participation in phase 3 cancer treatment trials.2017https://dx.doi.org/10.1136/bmjopen-2016-012666
N.B. These documents automatically identified may not have been verified by the study sponsor.