Consent for genomic tests in cancer: Pilot of a question prompt list & dynamic consent platform
Enhancing quality of informed consent for genomic tests: Pilot RCT of a question prompt list & dynamic consent platform for cancer patients
The University of Sydney
120 participants
Jul 30, 2025
Interventional
Conditions
Summary
This study aims to assess the feasibility and acceptability of two new decision support interventions for patients with cancer who are considering taking part in a genomics research program. Who is it for? This study is for people who have very recently joined a cancer genomics research program named CaSP. Patients eligible for CaSP are aged 18 years or older, have been diagnosed with an incurable, advanced and/or metastatic tumour of any cancer type, and are willing to undergo genomic testing by providing a tissue sample of their tumour. Study details Participants who choose to enrol in this study will be allocated randomly by chance (similar to flipping a coin) to one of three groups. Participants allocated to the first group will undergo the standard CaSP consent procedure, which involves viewing an online video animation and/or a written document describing CaSP and what taking part involves. Participants allocated to the second group will undergo the standard CaSP consent procedure and then will also receive a Question Prompt List, which is a structured list of questions and answers relevant to genomic testing/research that they can review in their own time. Participants allocated to the third group will undergo the standard CaSP consent procedure and then will also be given access to a Dynamic Consent Platform, an interactive website designed to support participants to access information and provide informed consent for genomic testing/research, which also incorporates the Question Prompt List. It is hoped this research will determine whether having access to a question prompt list and/or a dynamic consent platform is feasible and acceptable for patients with cancer and indicate whether access to these tools may have a positive impact on their understanding of genomic testing and how they feel about consenting to a genomic testing program.
Eligibility
Plain Language Summary
Simplified for easier understanding
This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.
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Interventions
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.
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ACTRN12625000287437