Digital Delivery of Information About Genetic Testing for Breast Cancer

NCT04842799 | Completed

• 3 other identifiers: CCR5234C61296/A2942347406
• Study Type: interventional
• Target: 1,140
• Locations: 1 country
• Sites: 5

Brief 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

Keywords

Genetic Testing; Digital Intervention

Outcome Measures

Primary Outcomes (1)

• Uptake of genetic testing

  Proportion of patients proceeding with the BRCA-gene test following receipt of pre-test information

  From the point the participant completes the initial Expression of Interest form at Enrolment, until the participant completes the BRCA-test consent approx. 1-3 weeks later.

Secondary Outcomes (7)

• Knowledge about genetic testing for BRCA genes

  7 days after the BRCA-test consent has been signed the patient will complete the Knowledge Questionnaire

• Anxiety following delivery of pre-test information and test results by the Spielberger State-Trait anxiety inventory

  The participant completes Quality of Life Questionnaires at baseline, 7 days after BRCA-test consent and then at 7 and 28 days after the notification that the patients BRCA-test results are available

• Assessment of number of participants who uptake of digital genetic testing

  The point at enrolment where the participant completes the initial expression of interest form

• 'Test-offer-to-results' time

  The point at enrolment where the participant completes the expression of interest form until the notification that the patients BRCA-test results are available (approx. 6-8 weeks)

• Helpline usage

  The point at which a participant who has been randomised to digital delivery of pre-test information contacts the telephone helpline, between date of randomisation and date of participant withdrawal/study completion 28 days after receiving test results

Study Arms (4)

Digital delivery of genetic pre-test information

EXPERIMENTAL

Half of participants will be provided with genetic pre-test information via the BRCA-DIRECT digital platform.

Other: Digital Delivery of Pre-Genetic Testing Information via the BRCA-DIRECT Platform

Genetic counselling telephone appointment to discuss genetic pre-test information

NO INTERVENTION

Half of participants will be provided with genetic pre-test information via the normal standard pathway - a telephone consultation with a Genetic Counsellor.

Digital delivery of BRCA-gene testing results

EXPERIMENTAL

97.5% of participant's with a negative (normal) result will receive their BRCA-gene testing result via the BRCA-DIRECT digital platform.

Other: Digital Delivery of Genetic Test Results via the BRCA-DIRECT Platform

Genetic counselling telephone appointment to discuss BRCA-gene testing results

NO INTERVENTION

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.

Interventions

Digital Delivery of Pre-Genetic Testing Information via the BRCA-DIRECT Platform OTHER

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 pre-test information

Digital Delivery of Genetic Test Results via the BRCA-DIRECT Platform OTHER

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.

Digital delivery of BRCA-gene testing results

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Previous testing for BRCA1/2

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead
• University of Sussex: collaborator
• University of Manchester: collaborator
• Cancer Research UK: collaborator

Study Sites (5)

Wythenshawe Hospital

Manchester, England, M23 9LT, United Kingdom

Location

Royal Marsden Hospital, Chelsea

Chelsea, London, SW3 6JJ, United Kingdom

Location

Royal Marsden Hospital, Kingston

Kingston, London, KT2 7QB, United Kingdom

Location

Royal Marsden Hospital, Sutton

Sutton, Surrey, SM2 5PT, United Kingdom

Location

North Manchester General Hospital

Manchester, M8 5RB, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 35868849 BACKGROUND

• 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.

  PMID: 39349619 DERIVED

Related Links

• 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)

Study Officials

• Gareth Evans

  Manchester University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Angela George

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are initially randomised 1:1 to receive genetic pre-test information either via the BRCA-DIRECT digital platform or a genetic counselling telephone appointment. Once the participants BRCA-gene test result becomes available, they are then randomised sequentially depending on the result of the genetic test. Participants with a negative (normal) result are randomised to receive this information either via the BRCA-DIRECT digital platform or a genetic counselling telephone appointment. Participants with a positive result will not be randomised and instead will always have a genetic counselling telephone appointment.

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 13, 2021
• Study Start: July 5, 2021
• Primary Completion: September 1, 2022
• Study Completion: January 16, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)