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

In patients newly diagnosed with breast cancer, will those who receive educational materials about treatment-focused genetic testing experience outcomes (including anxiety, depression, decisional conflict, knowledge of treatment-focused genetic testing, uptake of genetic testing and/or surgery choice) that are no worse than in patients who undergo standard familial cancer centre consultation only.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000502033

Acronym

Treatment focused And Responsive Genetic Testing (TARGET) study

Enrollment

120

Registered

2010-06-17

Start date

2010-08-11

Completion date

2012-10-05

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

This study looks at different ways of presenting information to women who are considering whether to have genetic testing around the time they are diagnosed with breast cancer. Who is it for? You can join this study if you are a woman who has recently been diagnosed with breast cancer, and you have a high risk of inherited breast cancer and you are interested in genetic testing. Trial details Participants will be randomly divided into two groups. One group will receive information about treatment-focused genetic testing (TFGT) in a face-to-face standard care consultation at a familial- cancer clinic (control), while the second group (intervention) will receive a brief educational pamphlet. Participants take part in four surveys assessing outcomes over 12 months. All participants will be offered the opportunity to have genetic testing and to discuss their results with a genetics specialist. The study aims to find the best way to deliver information about TFGT because this testing may be offered more routinely in the future and the results can influence treatment, including the type of surgery undertaken.

Interventions

A brief pamphlet about treatment-focused genetic testing (TFGT) for breast cancer will be posted to women allocated to the intervention group once the baseline questionnaire is complete (about one week after diagnosis). Information covered includes: - what is TFGT - why do TFGT - how the test is done - implications of test results

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Educational / counselling / training

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

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.

Outcome results