Clinical trial · Interventional
Digital Delivery of Information About Genetic Testing for Breast Cancer
BRCA-DIRECT: Randomised Evaluation in Women Diagnosed With Breast Cancer of Digitally-delivered Pre-test Information for BRCA-testing
NCT04842799CI-TRIAL-00066212BRCA-DIRECTcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasm Female | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Digital Delivery of Genetic Test Results via the BRCA-DIRECT Platform | Other | — | UNRESOLVED |
| Digital Delivery of Pre-Genetic Testing Information via the BRCA-DIRECT Platform | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Digital delivery of genetic pre-test information
- description
- Half of participants will be provided with genetic pre-test information via the BRCA-DIRECT digital platform.
- interventionNames
- Other: Digital Delivery of Pre-Genetic Testing Information via the BRCA-DIRECT Platform
- type
- NO_INTERVENTION
- label
- Genetic counselling telephone appointment to discuss genetic pre-test information
- description
- Half of participants will be provided with genetic pre-test information via the normal standard pathway - a telephone consultation with a Genetic Counsellor.
- type
- EXPERIMENTAL
- label
- Digital delivery of BRCA-gene testing results
- description
- 97.5% of participant's with a negative (normal) result will receive their BRCA-gene testing result via the BRCA-DIRECT digital platform.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of invasive breast cancer or high-grade ductal carcinoma in situ (DCIS) * Female * Aged 18 years or over * Access to smartphone or email + internet * Good comprehension of the English Language Exclusion Criteria: • Previous testing for BRCA1/2
References
Publications (2)
- BACKGROUNDTorr 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. PMID 35868849
- DERIVEDTorr 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. PMID 39349619