YoDA BRCA: Genetic Testing Decision Aid for young women
Research type
Research Study
Full title
YoDA BRCA: Development and pilot testing of a web-based Genetic Testing Decision Aid for young women newly diagnosed with early stage breast cancer
IRAS ID
161230
Contact name
Sharon Atwill
Contact email
Sponsor organisation
University of Southampton
Clinicaltrials.gov Identifier
12265, University of Southampton ERGO Ref
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Women diagnosed with breast cancer at a young age are more likely to have inherited a mutation in the high-risk predisposition genes BRCA1 and BRCA2. Genetic testing at the time of cancer diagnosis is not standard practice but is becoming more common in the UK, especially amongst younger women (under 50) and those with a family history of breast cancer (http://guidance.nice.org.uk/CG/Wave25/1). However, comprehensive information about genetic testing aimed specifically at these women is often not available outside of a specialist regional genetics service.
Genetic testing has far-reaching implications for women and for their families. The testing may be offered during cancer treatment in order to help women make a decision about whether to have a risk-reducing bilateral mastectomy. Information to support decisions about genetic testing has been identified by patients as a priority area for research.
Decision Aids are information sources that provide relevant information to patients, reducing uncertainty and supporting shared decision-making by outlining risks and benefits and clarifying values that matter the most to an individual patient.This study will collect evidence from published literature, health professionals and breast cancer patients to inform the development of a DA to support decisions regarding genetic testing to determine BRCA1/2 mutations, particularly at or near the time of cancer diagnosis. The DA will be developed and piloted in collaboration with the Breast Cancer Care Service User Research Partnership. Further work will involve a large randomised controlled trial (beyond this project) to test the effectiveness of the DA with regards to its effectiveness to support genetic testing decision-making, and as a result impact positively on young women’s quality of life by reducing uncertainty and increasing satisfaction with decisions made.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
14/SW/1181
Date of REC Opinion
13 Jan 2015
REC opinion
Further Information Favourable Opinion