Digital Delivery of Information About Genetic Testing for Breast Cancer
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- STATUS
- Recruiting
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- End date
- Dec 11, 2022
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- participants needed
- 1000
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- sponsor
- Institute of Cancer Research, United Kingdom
Summary
BRCA-DIRECT is a pragmatic, randomised, non-inferiority evaluation that aims to evaluate whether digital delivery of pre-test information for BRCA-testing in breast cancer patients is non-inferior to current standard practice of 1:1 delivery from a healthcare professional as measured by rate of uptake of the genetic testing.
Description
Participants will be recruited via breast clinics in two oncology centres. Patients will be provided with a study pack containing information about the study. If in clinic, the patient can complete an expression of interest form and a saliva/blood sample will be stored until consent to the study is received. The consent form and saliva sample can be completed at home and sent to the study team.
On receipt of a signed study consent form, the local site will confirm the patient's eligibility and enter details required for study conduct onto the BRCA-DIRECT databases.
After 24 hours, the participant will be sent a link to the BRCA-DIRECT study platform interface. This link enables the participant to progress through the study or withdraw if they have changed their mind.
Participants will be randomised 1:1 to receive either:
- Telephone consultation with a genetic counsellor (standard of care) The telephone consultations will be as per standard practice of the qualified genetic counsellor delivering the pre-test information.
- Digital delivery of pre-test information via BRCA-DIRECT platform (intervention)
Participants will receive a link to the digital pre-test information. This will consist of text covering:
- Genetics and cancer risk
- Genetics testing
- What will happen if your test is positive
- What will happen if your test is negative
- Implications for insurance
All participants will have access to a Genetic Counsellor hotline at all stages of the process.
For both arms, if a participant decides to proceed with the genetic test they will sign a digital 'BRCA-test consent' form, which will be formatted to BSGM (British Society of Genomic Medicine) standards. All participants will receive a copy of their signed BRCA-test consent form via secure email/post. The participant will have two days following test-consent to reverse the decision to proceed with the BRCA-test. Beyond those two days, the test will proceed.
The laboratory testing is a standard UK NHS (National Health Service) genetic test. This is delivered for both the intervention arm and the standard-of-care arm.
Participants with a negative (normal) genetic test result will be randomised to receive results either digitally, or via telephone consultation with the Genetic Counsellor. Any individuals with a positive result will receive their result by telephone. Following delivery of results, a results letter and copy of the pathology report will be sent to the participant and their medical team.
The participants will be invited to complete Quality of Life questionnaires, a knowledge test and satisfaction survey at various time points throughout the study via the BRCA-DIRECT platform.
Details
| Condition | Breast Neoplasm Female |
|---|---|
| Treatment | Digital Delivery of Pre-Genetic Testing Information via the BRCA-DIRECT Platform, Digital Delivery of Genetic Test Results via the BRCA-DIRECT Platform |
| Clinical Study Identifier | NCT04842799 |
| Sponsor | Institute of Cancer Research, United Kingdom |
| Last Modified on | 11 December 2021 |
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.
Learn moreIf you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
Learn moreComplete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.
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