AzTrials
AzTrials

Breast Neoplasm FemaleBRCA-DIRECTNCT04842799

Digital Delivery of Information About Genetic Testing for Breast Cancer

A study testing Digital Delivery of Pre-Genetic Testing Information via the BRCA-DIRECT Platform and Digital Delivery of Genetic Test Results via the BRCA-DIRECT Platform in people with Breast Neoplasm Female, run by Institute of Cancer Research, United Kingdom at 5 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Breast Neoplasm Female
What is being tested?
Digital Delivery of Pre-Genetic Testing Information via the BRCA-DIRECT Platform and Digital Delivery of Genetic Test Results via the BRCA-DIRECT Platform
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,140 participants
Where
5 sitesUnited Kingdom
Study dates
5 Jul 2021to 16 Jan 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Previous testing for BRCA1/2

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United Kingdom5 sites

  • Royal Marsden Hospital, Chelsea

    Chelsea, London, SW3 6JJ

  • Royal Marsden Hospital, Kingston

    Kingston, London, KT2 7QB

  • Wythenshawe Hospital

    Manchester, England, M23 9LT

  • North Manchester General Hospital

    Manchester, M8 5RB

  • Royal Marsden Hospital, Sutton

    Sutton, Surrey, SM2 5PT

Other trials in United Kingdom

About this study

Official title: BRCA-DIRECT: Randomised Evaluation in Women Diagnosed With Breast Cancer of Digitally-delivered Pre-test Information for BRCA-testing

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.

Read the 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.

Being tested
Digital Delivery of Pre-Genetic Testing Information via the BRCA-DIRECT Platform, Digital Delivery of Genetic Test Results via the BRCA-DIRECT Platform
Keywords
Genetic Testing, Digital Intervention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital Delivery of Pre-Genetic Testing Information via the BRCA-DIRECT PlatformOther

    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 Test Results via the BRCA-DIRECT PlatformOther

    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.

Study groups in NCT04842799
Study groupRoleWhat they receive
Digital delivery of genetic pre-test informationExperimentalHalf of participants will be provided with genetic pre-test information via the BRCA-DIRECT digital platform.
Receives: Other: Digital Delivery of Pre-Genetic Testing Information via the BRCA-DIRECT Platform
Genetic counselling telephone appointment to discuss genetic pre-test informationNo interventionHalf 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 resultsExperimental97.5% of participant's with a negative (normal) result will receive their BRCA-gene testing result via the BRCA-DIRECT digital platform.
Receives: Other: Digital Delivery of Genetic Test Results via the BRCA-DIRECT Platform
Genetic counselling telephone appointment to discuss BRCA-gene testing resultsNo intervention2.5% 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Uptake of genetic testing

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

    Measured: 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)

  1. Knowledge about genetic testing for BRCA genes

    Test participant knowledge following delivery of pre-test information via a Knowledge Questionnaire (study specific) of 12 True/False/Unsure questions for a total possible score of 12/12.

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

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

    Participant Quality of Life Questionnaire scores collected before pre-test information and after test results received. The Spielberger state-trait anxiety inventory (STAI) consists of two self-administered, 20-item questionnaires, with each item rated on a four-point Likert scale. It assesses anxiety proneness (trait) and the current state of anxiety change (state). The Trait anxiety is measured only once before pre-test information, and the State at each time point. High STAI scores signify greater anxiety.

    Measured: 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

  3. Assessment of number of participants who uptake of digital genetic testing

    Potential participant decline on account of lack of digital access

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

  4. 'Test-offer-to-results' time

    To compare 'Test-offer-to-results' time of the BRCA-DIRECT digital model compared to an audit of timings under current pathways at participating centres

    Measured: 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)

  5. Helpline usage

    Evaluate proportion of patients receiving digital pre-test information who require 1:1 discussion via the helpline

    Measured: 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

  6. Healthcare professional satisfaction

    Healthcare Professional Feedback Survey completion to evaluate how satisfied Healthcare professionals were with the BRCA-DIRECT digital model

    Measured: 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).

  7. Patient satisfaction

    Participant Satisfaction Survey (study specific) completion to evaluate how satisfied patients were with the BRCA-DIRECT digital model, consisting of 9 questions, of which 3 are ranked on a scale of 1-5 (1 - not satisfied to 5 - very satisfied) and others are multi-choice.

    Measured: 7 days after the notification that the patients BRCA-test results are available the participant completes the Participant Satisfaction Survey

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2021
  2. Study start5 Jul 2021
  3. Primary completion1 Sep 2022
  4. Study completion16 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Sequential
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.
Masking
None (open label)
Enrolment
1,140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04842799
Sponsor's protocol ID
CCR5234
Other IDs
C61296/A29423, 47406
Acronym
BRCA-DIRECT
Status last verified
May 2023
First submitted
7 Apr 2021
Last updated
6 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35868849

  • 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.

    PubMed 39349619

Questions about this trial

What is this clinical trial studying?

A study testing Digital Delivery of Pre-Genetic Testing Information via the BRCA-DIRECT Platform and Digital Delivery of Genetic Test Results via the BRCA-DIRECT Platform in people with Breast Neoplasm Female, run by Institute of Cancer Research, United Kingdom at 5 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Uptake of genetic testing (time frame: 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04842799, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in