Clinical trial NCT04842799: Digital Delivery of Information About Genetic Testing for Breast Cancer
Official title: BRCA-DIRECT: Randomised Evaluation in Women Diagnosed With Breast Cancer of Digitally-delivered Pre-test Information for BRCA-testing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Neoplasm Female
Keywords: Genetic Testing
Digital Intervention
Lead sponsor: Institute of Cancer Research, United Kingdom
Sponsor class: OTHER
Collaborators: name: University of Sussex
name: University of Manchester
name: Cancer Research UK
First posted: 2021-04-13
Enrollment: 1140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: 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.
Primary purpose: OTHER

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Uptake of genetic testing
timeFrame: 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:
measure: Knowledge about genetic testing for BRCA genes
timeFrame: 7 days after the BRCA-test consent has been signed the patient will complete the Knowledge Questionnaire
measure: Anxiety following delivery of pre-test information and test results by the Spielberger State-Trait anxiety inventory
timeFrame: 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
measure: Assessment of number of participants who uptake of digital genetic testing
timeFrame: The point at enrolment where the participant completes the initial expression of interest form
measure: 'Test-offer-to-results' time
timeFrame: 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)
measure: Helpline usage
timeFrame: 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
measure: Healthcare professional satisfaction
timeFrame: Healthcare professional completes the Healthcare Professional Feedback Survey after interacting with the study, following completion of all patients through the study (approximately 14 months from study recruitment start).
measure: Patient satisfaction
timeFrame: 7 days after the notification that the patients BRCA-test results are available the participant completes the Participant Satisfaction Survey
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
state: England
city: Chelsea
country: United Kingdom
facility: Royal Marsden Hospital, Chelsea
state: London
city: Kingston
country: United Kingdom
facility: Royal Marsden Hospital, Kingston
state: London
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital, Sutton
state: Surrey
city: Manchester
country: United Kingdom
facility: North Manchester General Hospital
Study officials:
affiliation: Manchester University NHS Foundation Trust
name: Gareth Evans
role: PRINCIPAL_INVESTIGATOR
affiliation: Royal Marsden NHS Foundation Trust
name: Angela George
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.