Assessing the impact of personalised risk estimates on the uptake and timing of risk management options in women who have inherited a change in genes associated with an increased risk of breast and ovarian cancer

Stratifying risk for early detection in hereditary breast and ovarian cancer

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN15331714

Enrollment

600

Registered

2022-06-21

Start date

2022-05-01

Completion date

Unknown

Last updated

2025-09-15

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

Conditions

Hereditary breast and ovarian cancer Cancer

Interventions

Women who agree to take part in the study will be asked to complete a short questionnaire which will include basic demographics along with details regarding relevant risk factors (family history of ca

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Female 2. Age >18 years 3. Undergoing predictive testing for a PV in BRCA1, BRCA2, PALB2, ATM or CHEK2 4. Able to give informed consent

Exclusion criteria

Exclusion criteria: Previous history of breast cancer or ovarian cancer

Design outcomes

Primary

Measure	Time frame
The type and the timing of risk management options (surveillance, chemoprevention, surgery) taken up over the course of the study (i.e. 12 months) measured via 4 questionnaires (baseline, then 1, 3 and 12 months post-results)	—

Secondary

Measure	Time frame
1. The type of risk management options planned to be taken up in the future (i.e. beyond the end of the study). measured via questionnaires at 1, 3 and 12 months post-results). 2. Informed decision-making about risk management options (measured by combining objective knowledge, attitude and behaviour) measured via questionnaires at 1, 3 and 12 months post-results). 3. Women’s understanding of the test result measured via questionnaires at 1, 3 and 12 months post-results). 4. Psycho-social impact (including cancer worry, anxiety and quality of life), measured via 4 questionnaires (baseline, then at 1, 3 and 12 months post-results). 5. Information on women’s use of health services will also be captured in order to perform a cost-utility analysis measured via 4 questionnaires (baseline, then at 1, 3 and 12 months post-results). 6. Exploring the acceptability and implementation of personalised risk calculations in clinical genetics services measured by semi-structured interviews with patients and staff at 12 months.	—

Measure

Time frame

1. The type of risk management options planned to be taken up in the future (i.e. beyond the end of the study). measured via questionnaires at 1, 3 and 12 months post-results). 2. Informed decision-making about risk management options (measured by combining objective knowledge, attitude and behaviour) measured via questionnaires at 1, 3 and 12 months post-results). 3. Women’s understanding of the test result measured via questionnaires at 1, 3 and 12 months post-results). 4. Psycho-social impact (including cancer worry, anxiety and quality of life), measured via 4 questionnaires (baseline, then at 1, 3 and 12 months post-results). 5. Information on women’s use of health services will also be captured in order to perform a cost-utility analysis measured via 4 questionnaires (baseline, then at 1, 3 and 12 months post-results). 6. Exploring the acceptability and implementation of personalised risk calculations in clinical genetics services measured by semi-structured interviews with patients and staff at 12 months.

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Countries

England, United Kingdom, United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026