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Digital Delivery of Information About Genetic Testing for Breast Cancer

NCT04842799 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1140

Last updated 2023-05-06

No results posted yet for this study

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.

Conditions

  • Breast Neoplasm Female

Interventions

OTHER

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.

OTHER

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.

Sponsors & Collaborators

  • University of Sussex

    collaborator OTHER

  • University of Manchester

    collaborator OTHER

  • Cancer Research UK

    collaborator OTHER

  • Institute of Cancer Research, United Kingdom

    lead OTHER

Principal Investigators

  • Gareth Evans · Manchester University NHS Foundation Trust

  • Angela George · Royal Marsden NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-05
Primary Completion
2022-09-01
Completion
2023-01-16

Countries

  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04842799 on ClinicalTrials.gov