Too much, too soon? The impact of treatment-focused genetic testing in patients newly diagnosed with breast cancer.

Not Applicable

Completed

• Conditions: early or locally advanced breast cancer; Women at increased risk for carrying a faulty gene for breast and/or ovarian cancer; Cancer - Breast; Human Genetics and Inherited Disorders - Other human genetics and inherited disorders

• Registration Number: ACTRN12610000502033
• Lead Sponsor: Prince of Wales Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-06-17
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

Women aged between 18 and <50 years with early or locally advanced breast cancer will be eligible if they exhibit at least one of the following risk features:
1. A strong family history of breast and/or ovarian cancer, that is There are now (with the new diagnosis) three or more close relatives on one side of the family with breast or ovarian cancer OR There are now (with the new diagnosis) at least two close relatives on one side of the family with breast or ovarian cancer PLUS a high-risk feature (breast cancer diagnosed before the
age of 40, bilateral breast cancer, breast and ovarian cancer in the same woman, Ashkenazi Jewish ancestry, breast cancer in a male relative)

OR

2. No or minimal family history of breast and/or ovarian cancer AND presence of Bilateral breast cancer AND/OR Ashkenazi Jewish ancestry AND/OR Triple negative breast cancer (oestrogen and progesterone receptor and Human Epidermal growth factor Receptor 2 (HER2) negative tumour)

Exclusion Criteria

Women who have already had genetic counselling at a Familial Cancer Clinic (FCC) and/or testing will
be excluded. Women with metastatic breast cancer (Stage IV) will also be excluded, as their surgical options will be determined largely by disease characteristics rather than choice.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Through a non-inferiority trial we will test the hypothesis that patient outcomes (anxiety, depression, decisional conflict, knowledge of treatment-focused genetic testing, uptake of genetic testing and/or surgery choice) will be no worse in the intervention group compared to the control group. Anxiety and depression will be assessed using the validated Hospital Anxiety and Depression scale, decisional conflict will be assessed using the validated Decisional Conflict Scale, knowledge will be assessed using a purposely developed 10 item questionnaire that has been piloted, and uptake will be acertained from medical records.[At diagnosis, 1 week, 2 weeks, 6 weeks and 58 weeks.]

Secondary Outcome Measures

Name	Time	Method
Women who opt for treatment-focused genetic testing will have a higher uptake of bilateral mastectomy compared to data from the Royal Australasian College of Surgeons Breast Cancer Audit on over 12,000 women with early breast cancer diagnosed annually. Medical records will be accessed retrospectively to obtain data.[12 months after diagnosis]