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Completed

NCT Number: NCT04842799

Digital Delivery of Information About Genetic Testing for Breast Cancer

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.

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Key information

Conditions

Breast Neoplasm Female

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Wythenshawe Hospital, Manchester, England, United Kingdom

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About this study

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:

  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 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.

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. Knowledge about genetic testing for BRCA genes

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

    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.

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

    Time frame: 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

    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.

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

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

    Potential participant decline on account of lack of digital access

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

    Time frame: 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)

    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

  5. Helpline usage

    Time frame: 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

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

  6. Healthcare professional satisfaction

    Time frame: 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).

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

  7. Patient satisfaction

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

    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.

Sponsors and collaborators

Lead sponsor

Institute of Cancer Research, United Kingdom

Other

Collaborators

  • Cancer Research UK
  • University of Manchester
  • University of Sussex

Registry information

Official study title

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

Acronym: BRCA-DIRECT

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Apr 13, 2021
Registry last updated
May 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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