BRCA-DIRECT
Research type
Research Study
Full title
BRCA-DIRECT: randomised evaluation in women diagnosed with breast cancer of digitally-delivered pre-test information for BRCA-testing
IRAS ID
278052
Contact name
Clare Turnbull
Contact email
Sponsor organisation
Institute of Cancer Research
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 11 months, 31 days
Research summary
Summary of Research
BRCA-DIRECT- Is digitally delivered information about genetic testing feasible, effective and acceptable to women with breast cancer?Compared to the general population, women who have fault in their BRCA1, BRCA2 or PALB2 gene (a pathogenic_variant) have a higher risk of developing breast and ovarian cancer. Currently, within the National Health Service (NHS), women with breast cancer are not routinely tested for these genes unless they have a strong family history of cancer. The results of a BRCA-gene test can be of vlaue in any woman with breast cancer as it can provide useful information on: (i) how to best treat the cancer, (ii) the risk of this, or other cancers returning, (ii) whether family members are at high risk of cancer.
Before having a BRCA-gene test, women are currently have a lengthy one-to-one consultation with a doctor or a genetic counsellor, who explains what the test results could mean for them and their families. Recent advances in technology for this test have brought down the cost and time taken to run it, but it is not being used widely within the NHS due to a lack of doctors and genetic counsellors available to provide genetic counselling.
This study will examine the feasibility, effectiveness and acceptability of delivering digital (online) information about BRCA gene testing to breast cancer patients at two UK hospital Trusts. 1000 women with breast cancer will be randomised to receive digital information about genetic testing via the 'BRCA-DIRECT' system or by a standard genetic counselling telephone appointment. Following this, participants will then decide whether to proceed with the BRCA-gene test.
Participating in the study will take 4-6 weeks and during this time participants will provide a saliva sample for the BRCA-gene test, receive pre-test information, complete eight questionnaires and a feedback survey. Test results will be provided to each participant.Summary of Results
In the UK, people may be offered genetic testing to see if their cancer might have an inherited cause. Before the genetic test is done, an appointment with a specialist called a genetic counsellor is needed, who explains the reasons we might offer genetic testing and what the possible results of the test mean. There may be other options, such as having this information online, which mean more people can be offered testing and reduce the time it takes for testing to begin. This study looked to see if having the information online was as acceptable as having it from a genetic counsellor. In total, 1,140 people took part in this study. They were put into two groups: 569 had their information online, and 571 had their information from a genetic counsellor. Everyone who took part could also call a telephone helpline if they had any questions. Of the two groups, more people who had their information online (515 of the 569 who took part, 91%) decided to have the genetic test compared to people who had their information from a genetic counsellor (486 of the 571 who took part, 85%). The telephone helpline was used by 90 people who had their information online (16% of the people in this group), and 111 people who had their information from a genetic counsellor (20% of the people in this group). The study also looked at knowledge about genetic testing (both before and after having their information), anxiety levels throughout the study, and satisfaction with the information given. Results were similar between the two groups for all of these factors. In summary, the study concluded that having information about genetic testing online, with telephone helpline support, could be a useful alternative to having information from a genetic counsellor.REC name
London - Chelsea Research Ethics Committee
REC reference
20/LO/1200
Date of REC Opinion
4 Jan 2021
REC opinion
Further Information Favourable Opinion