DETECT-2
Research type
Research Study
Full title
Direct to Patient Testing at Cancer Diagnosis for Precision Prevention-2
IRAS ID
319066
Contact name
Ranjit Manchanda
Contact email
Sponsor organisation
Queen Mary University of London
Duration of Study in the UK
4 years, 11 months, 30 days
Research summary
All patients who are diagnosed with womb, bowel, or ovary cancer are recommended to have genetic-testing to see if their cancer was related to an inherited gene alteration. Identifying carriers of alterations allows novel personalised cancer treatments, prevention of second cancers, and testing of family members for cancer screening and prevention.
Genetic testing requires pre-test counselling to ensure patients are informed about the impact of having a genetic test and managing the result. This ‘genetic-counselling’ has traditionally been provided by genetics services. However, it is now routinely being offered by cancer-treating teams in an approach called “mainstreaming”. Currently, the demand for genetic counselling and testing is swiftly increasing and capacity constraints requires development of new scalable cost and resource efficient implementation models.
The DETECT-2 study will assess if pre-test counselling and genetic-testing can be done using a direct-to-patient model. In this model, participants will receive genetic testing information on a smart-phone app or website that they can access at home along-with counselling support through a study telephone helpline. Those who agree to testing can consent via the app and perform testing at home by a saliva genetic testing kit delivered and returned by post. In the study this direct-to-patient approach is directly compared to the standard mainstreaming approach in a randomized trial. Cancer patients who are eligible for genetic testing under current NHS criteria will be recruited to the study from NHS hospitals. The web-app is an information giving support aid.
The study compares and evaluates the uptake of genetic testing using both approaches. We also assess patient satisfaction, quality-of-life, and psychological outcomes following testing, using standardized or customized questionnaires over one year. Clinician opinions will be elicited. Some patients will also be interviewed to assess attitudes, experiences, and impact on emotional wellbeing. An economic analysis will be undertaken to assess the cost-effectiveness of this approach for the NHS.REC name
London - Brighton & Sussex Research Ethics Committee
REC reference
23/LO/0677
Date of REC Opinion
29 Aug 2023
REC opinion
Further Information Favourable Opinion