BRCA-DIRECT- Is digitally delivered information about genetic testing feasible, effective and acceptable to women with breast cancer?

BRCA-DIRECT: randomised evaluation in women diagnosed with breast cancer of digitally-delivered pre-test information for BRCA-testing

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN87845055

Enrollment

1000

Registered

2021-01-28

Start date

2021-06-01

Completion date

Unknown

Last updated

2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer Cancer Malignant neoplasm of breast

Interventions

Participants will be sent a link to the BRCA-DIRECT online system at least 24 hours after the signed consent form was received. They will be asked to complete a medical family history questionnaire, t

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Diagnosis of invasive breast cancer or high grade Ductal Carcinoma in Situ (DCIS) 2. Aged 18 years or over 3. Access to smartphone or email and internet 4. Good comprehension of the English Language

Exclusion criteria

Exclusion criteria: Previously tested for any of BRCA genes BRCA1, BRCA2, PALB2

Design outcomes

Primary

Measure	Time frame
The proportion of patients proceeding to genetic testing following delivery of pre-test information measured using case report forms	—

Secondary

Measure	Time frame
1. Knowledge about genetic testing for BRCA genes measured using the Knowledge Questionnaire 7 days after the BRCA-test consent has been signed 2. Anxiety following delivery of pre-test information, and test results, in the two allocated groups (State Trait Anxiety Inventory scores and intolerance of uncertainty questionnaire) 3. Uptake of digital genetic testing (decline rates and reasons will be assessed by expression of interest forms throughout the study) 4. ‘Test-offer-to-results’ time (Audit of study timelines vs current SOC within service) 5. Uptake of telephone helpline (Central log retained throughout the study) 6. Healthcare professional satisfaction with BRCA-DIRECT digital model (survey at 7 days) 7. Patient satisfaction with BRCA-DIRECT digital model (satisfaction survey at 7 days and detailed interviews within pilot phase)	—

Measure

Time frame

1. Knowledge about genetic testing for BRCA genes measured using the Knowledge Questionnaire 7 days after the BRCA-test consent has been signed 2. Anxiety following delivery of pre-test information, and test results, in the two allocated groups (State Trait Anxiety Inventory scores and intolerance of uncertainty questionnaire) 3. Uptake of digital genetic testing (decline rates and reasons will be assessed by expression of interest forms throughout the study) 4. ‘Test-offer-to-results’ time (Audit of study timelines vs current SOC within service) 5. Uptake of telephone helpline (Central log retained throughout the study) 6. Healthcare professional satisfaction with BRCA-DIRECT digital model (survey at 7 days) 7. Patient satisfaction with BRCA-DIRECT digital model (satisfaction survey at 7 days and detailed interviews within pilot phase)

—

Countries

England, United Kingdom

Contacts

Public ContactBethany Torr

BRCADIRECT@icr.ac.uk+44 (0)20 8722 4626

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 11, 2026