Digital Delivery of Information About Genetic Testing for Breast Cancer
NCT ID: NCT04842799
Last Updated: 2023-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1140 participants
INTERVENTIONAL
2021-07-05
2023-01-16
Brief Summary
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Detailed Description
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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:
1. 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.
2. 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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
NONE
Study Groups
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Digital delivery of genetic pre-test information
Half of participants will be provided with genetic pre-test information via the BRCA-DIRECT digital platform.
Digital Delivery of Pre-Genetic Testing Information via the BRCA-DIRECT Platform
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.
Where relevant, parts of the text will be linked through to additional information, such as insurance advice from the Association of British Insurers. Participants will be able to call a genetic counsellor on the hotline during weekday office hours, should they have any questions or require further information.
Genetic counselling telephone appointment to discuss genetic pre-test information
Half of participants will be provided with genetic pre-test information via the normal standard pathway - a telephone consultation with a Genetic Counsellor.
No interventions assigned to this group
Digital delivery of BRCA-gene testing results
97.5% of participant's with a negative (normal) result will receive their BRCA-gene testing result via the BRCA-DIRECT digital platform.
Digital Delivery of Genetic Test Results via the BRCA-DIRECT Platform
Participants will receive a digital message that their results are available. When they click this, they will receive digital notification of their negative (normal) result in short form. Full details will be provided in an individualised letter.
Genetic counselling telephone appointment to discuss BRCA-gene testing results
2.5% of participants with a negative (normal) result and those with positive results will receive their BRCA-gene testing result via the normal standard pathway - a telephone consultation with a Genetic Counsellor.
No interventions assigned to this group
Interventions
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Digital Delivery of Pre-Genetic Testing Information via the BRCA-DIRECT Platform
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.
Where relevant, parts of the text will be linked through to additional information, such as insurance advice from the Association of British Insurers. Participants will be able to call a genetic counsellor on the hotline during weekday office hours, should they have any questions or require further information.
Digital Delivery of Genetic Test Results via the BRCA-DIRECT Platform
Participants will receive a digital message that their results are available. When they click this, they will receive digital notification of their negative (normal) result in short form. Full details will be provided in an individualised letter.
Eligibility Criteria
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Inclusion Criteria
* Female
* Aged 18 years or over
* Access to smartphone or email + internet
* Good comprehension of the English Language
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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University of Sussex
OTHER
University of Manchester
OTHER
Cancer Research UK
OTHER
Institute of Cancer Research, United Kingdom
OTHER
Responsible Party
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Principal Investigators
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Gareth Evans
Role: PRINCIPAL_INVESTIGATOR
Manchester University NHS Foundation Trust
Angela George
Role: PRINCIPAL_INVESTIGATOR
Royal Marsden NHS Foundation Trust
Locations
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Wythenshawe Hospital
Manchester, England, United Kingdom
Royal Marsden Hospital, Chelsea
Chelsea, London, United Kingdom
Royal Marsden Hospital, Kingston
Kingston, London, United Kingdom
Royal Marsden Hospital, Sutton
Sutton, Surrey, United Kingdom
North Manchester General Hospital
Manchester, , United Kingdom
Countries
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References
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Torr B, Jones C, Choi S, Allen S, Kavanaugh G, Hamill M, Garrett A, MacMahon S, Loong L, Reay A, Yuan L, Valganon Petrizan M, Monson K, Perry N, Fallowfield L, Jenkins V, Gold R, Taylor A, Gabe R, Wiggins J, Lucassen A, Manchanda R, Gandhi A, George A, Hubank M, Kemp Z, Evans DG, Bremner S, Turnbull C. A digital pathway for genetic testing in UK NHS patients with cancer: BRCA-DIRECT randomised study internal pilot. J Med Genet. 2022 Dec;59(12):1179-1188. doi: 10.1136/jmg-2022-108655. Epub 2022 Jul 22.
Torr B, Jones C, Kavanaugh G, Hamill M, Allen S, Choi S, Garrett A, Valganon-Petrizan M, MacMahon S, Yuan L, Way R, Harder H, Gold R, Taylor A, Gabe R, Lucassen A, Manchanda R, Fallowfield L, Jenkins V, Gandhi A, Evans DG, George A, Hubank M, Kemp Z, Bremner S, Turnbull C. BRCA-DIRECT digital pathway for diagnostic germline genetic testing within a UK breast oncology setting: a randomised, non-inferiority trial. Br J Cancer. 2024 Nov;131(9):1506-1515. doi: 10.1038/s41416-024-02832-2. Epub 2024 Oct 1.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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A digital pathway for genetic testing in UK NHS patients with cancer: BRCA-DIRECT randomised study internal pilot (publication of pilot phase study data for the first 130 participants recruited)
Other Identifiers
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C61296/A29423
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
47406
Identifier Type: REGISTRY
Identifier Source: secondary_id
CCR5234
Identifier Type: -
Identifier Source: org_study_id
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