Digital Delivery of Information About Genetic Testing for Breast Cancer (BRCA-DIRECT)

Institute of Cancer Research, United Kingdom

Status: Completed

Conditions: Breast Neoplasm Female

Treatments: Other: Digital Delivery of Genetic Test Results via the BRCA-DIRECT Platform; Other: Digital Delivery of Pre-Genetic Testing Information via the BRCA-DIRECT Platform

Study type: Interventional

Funder types: Other

Identifiers

NCT04842799

CCR5234

C61296/A29423 (Other Grant/Funding Number)

47406 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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:

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.

Enrollment: 1,140 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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1,140 participants in 4 patient groups

Digital delivery of genetic pre-test information

Experimental group

Description:

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

Treatment:

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 group

Description:

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 group

Description:

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

Treatment:

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

Genetic counselling telephone appointment to discuss BRCA-gene testing results

No Intervention group

Description:

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.