Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000287437p
Ethics application status
Submitted, not yet approved
Date submitted
27/03/2025
Date registered
14/04/2025
Date last updated
14/04/2025
Date data sharing statement initially provided
14/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Consent for genomic tests in cancer: Pilot of a question prompt list & dynamic consent platform
Scientific title
Enhancing quality of informed consent for genomic tests: Pilot RCT of a question prompt list & dynamic consent platform for cancer patients
Secondary ID [1] 313690 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer genomics 336267 0
Condition category
Condition code
Cancer 332810 332810 0 0
Any cancer
Public Health 332811 332811 0 0
Health promotion/education
Mental Health 332812 332812 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be invited to join the current study immediately after they give their consent to take part in a cancer genomics research program, "CaSP". Having just completed the standard consent process for CaSP, intervention group participants will be asked to view and consider the current study materials as new additional resources that could potentially be incorporated into future consent processes for research programs like CaSP.

This study has two intervention groups. Both interventions will be accessed via a website designed specifically for this study, in which each participant will have their own account and login. There is no live messaging/chat feature. Participants can interact with the interventions at their own pace, in their own time. If desired, they can log out and log back in again at a different time, as many times as they wish. Participants will retain access to the interventions for the 3-month duration of the study follow-up.
 
Intervention 1 is a dynamic consent platform – a website that provides accessible, layered information about having a genomic test via a research program (e.g. CaSP) and steps users through the important elements of giving informed consent. Because participants in the current study will have already given informed consent, their interaction with the platform will be hypothetical in nature. Formats within the platform include short video animation and text. In addition to the static text displayed by default, there is additional text available to participants who wish to review further details by clicking on "more information" buttons throughout the platform. Time spent going through the platform will vary between participants, but the anticipated time needed to view all aspects of the platform is around 20-30 minutes. Note that Intervention 1 also incorporates Intervention 2.

Intervention 2 is a question prompt list – a question-and-answer document designed to provide brief, accessible answers to common/important questions that patients may have when considering genomic testing. The list of questions appears as on a page within the website as static text, and participants can click on any question(s) to view the corresponding answer(s).

Summary of content provided by both interventions: what testing is (purpose, procedure etc.), possible results and how/when they are provided, potential benefits of testing, potential unwanted consequences, limitations, who is conducting the research, what participants are asked to do, and what happens to their information.

Website analytics will be used to monitor engagement with the interventions, which is a key component of feasibility assessment.
Intervention code [1] 330284 0
Treatment: Other
Comparator / control treatment
Participants in the control arm will not receive any additional resources beyond the standard consent materials used by CaSP, which are in the form of an online video animation and/or downloadable participant information document.
Control group
Active

Outcomes
Primary outcome [1] 340341 0
Feasibility: Proportion of intervention content utilised (i.e. pages/items viewed)
Timepoint [1] 340341 0
Post-intervention (immediately after accessing intervention) and at 3-month follow-up
Primary outcome [2] 341012 0
Feasibility: Detailed usage and engagement with interventions
Timepoint [2] 341012 0
Post-intervention (immediately after accessing intervention) and at 3-month follow-up
Primary outcome [3] 341013 0
Satisfaction with interventions and their various components/aspects (purpose-designed)
Timepoint [3] 341013 0
Post-intervention (immediately after accessing intervention)
Secondary outcome [1] 443735 0
Indicator of potential efficacy: Subjective understanding of the key information required to give informed consent to participate in CaSP
Timepoint [1] 443735 0
Post-intervention (immediately after accessing intervention)
Secondary outcome [2] 445785 0
Exploratory: Participants' perceptions and experiences of using the interventions, and their feedback about the interventions
Timepoint [2] 445785 0
2-4 weeks after accessing the interventions and at 3-month follow-up
Secondary outcome [3] 445796 0
Knowledge
Timepoint [3] 445796 0
Post-intervention (immediately after accessing intervention)
Secondary outcome [4] 445797 0
Decisional conflict
Timepoint [4] 445797 0
Post-intervention (immediately after accessing intervention)
Secondary outcome [5] 445798 0
Satisfaction with decision
Timepoint [5] 445798 0
Post-intervention (immediately after accessing intervention)
Secondary outcome [6] 445799 0
Anxiety
Timepoint [6] 445799 0
Post-intervention (immediately after accessing intervention) and at 3-month follow-up
Secondary outcome [7] 445800 0
Decision regret
Timepoint [7] 445800 0
At 3-month post-intervention follow-up

Eligibility
Key inclusion criteria
a) Aged 18 years or older;
b) English language ability sufficient to read and understand study materials and do written questionnaires online, without requiring an interpreter;
c) Able and willing to engage with an online intervention;
d) Newly consented to Omico’s Cancer Screening Program (CaSP).

CaSP eligibility will have been previously confirmed by Omico staff and therefore does not fall directly within the remit of the present study protocol. For reference, key CaSP inclusion criteria are: pathologically confirmed incurable, advanced and/or metastatic tumour of any histologic type; life expectancy of equal to or greater than 3 months; sufficient and accessible tissue for molecular screening; ECOG performance status 0, 1 or 2; willing to comply with all CaSP protocol requirements, including long-term follow-up.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exclusion criteria specific to this study. CaSP exclusion criteria relate to comorbidities and history of cancer.

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)
Allocation to study arms will be conducted using a computerised approach via REDCap software, ensuring a centralised, secure, and unbiased process. The allocation sequence will be fully concealed from everyone involved, and will be implemented during the randomisation process taking place immediately following consent. Participants will self-enrol into the study, with no awareness of the allocation sequence.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/05/2025
Actual
Date of last participant enrolment
Anticipated
28/05/2025
Actual
Date of last data collection
Anticipated
29/08/2025
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 318156 0
Government body
Name [1] 318156 0
Cancer Institute NSW
Country [1] 318156 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 320538 0
None
Name [1] 320538 0
Address [1] 320538 0
Country [1] 320538 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316802 0
Monash Health Human Research Ethics Committee A
Ethics committee address [1] 316802 0
Ethics committee country [1] 316802 0
Australia
Date submitted for ethics approval [1] 316802 0
21/11/2024
Approval date [1] 316802 0
Ethics approval number [1] 316802 0

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

Contacts
Principal investigator
Name 139054 0
Dr Jolyn Hersch
Address 139054 0
School of Public Health, Edward Ford Building, The University of Sydney, NSW 2006
Country 139054 0
Australia
Phone 139054 0
+612 9036 9042
Fax 139054 0
Email 139054 0
[email protected]
Contact person for public queries
Name 139055 0
Jolyn Hersch
Address 139055 0
School of Public Health, Edward Ford Building, The University of Sydney, NSW 2006
Country 139055 0
Australia
Phone 139055 0
+612 9036 9042
Fax 139055 0
Email 139055 0
[email protected]
Contact person for scientific queries
Name 139056 0
Jolyn Hersch
Address 139056 0
School of Public Health, Edward Ford Building, The University of Sydney, NSW 2006
Country 139056 0
Australia
Phone 139056 0
+612 9036 9042
Fax 139056 0
Email 139056 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


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.