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BMC Cancer
Published in: BMC Cancer 1/2012

Open Access 01-12-2012 | Study protocol

How should we discuss genetic testing with women newly diagnosed with breast cancer? Design and implementation of a randomized controlled trial of two models of delivering education about treatment-focused genetic testing to younger women newly diagnosed with breast cancer

Authors: Kaaren J Watts, Bettina Meiser, Gillian Mitchell, Judy Kirk, Christobel Saunders, Michelle Peate, Jessica Duffy, Patrick J Kelly, Margaret Gleeson, Kristine Barlow-Stewart, Belinda Rahman, Michael Friedlander, Kathy Tucker, for the TFGT Collaborative Group

Published in: BMC Cancer | Issue 1/2012

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Abstract

Background

Germline BRCA1 and BRCA2 mutation testing offered shortly after a breast cancer diagnosis to inform women’s treatment choices - treatment-focused genetic testing ‘TFGT’ - has entered clinical practice in specialist centers and is likely to be soon commonplace in acute breast cancer management, especially for younger women. Yet the optimal way to deliver information about TFGT to younger women newly diagnosed with breast cancer is not known, particularly for those who were not suspected of having a hereditary breast cancer syndrome prior to their cancer diagnosis. Also, little is known about the behavioral and psychosocial impact or cost effectiveness of educating patients about TFGT. This trial aims to examine the impact and efficiency of two models of educating younger women newly diagnosed with breast cancer about genetic testing in order to provide evidence for a safe and effective future clinical pathway for this service.

Design/methods

In this non-inferiority randomized controlled trial, 140 women newly diagnosed with breast cancer (aged less than 50 years) are being recruited from nine cancer centers in Australia. Eligible women with either a significant family history of breast and/or ovarian cancer or with other high risk features suggestive of a mutation detection rate of > 10% are invited by their surgeon prior to mastectomy or radiotherapy. After completing the first questionnaire, participants are randomized to receive either: (a) an educational pamphlet about genetic testing (intervention) or (b) a genetic counseling appointment at a family cancer center (standard care). Each participant is offered genetic testing for germline BRCA mutations. Decision-related and psychosocial outcomes are assessed over 12 months and include decisional conflict (primary outcome);uptake of bilateral mastectomy and/or risk-reducing salpingo-oophorectomy; cancer-specific- and general distress; family involvement in decision making; and decision regret. A process-oriented retrospective online survey will examine health professionals’ attitudes toward TFGT; a health economic analysis will determine the cost effectiveness of the intervention.

Discussion

This trial will provide crucial information about the impact, efficiency and cost effectiveness of an educational pamphlet designed to inform younger women newly diagnosed with breast cancer about genetic testing. Issues regarding implementation of the trial are discussed.

Trial registration

The study is registered with the Australian and New Zealand Clinical Trials Group (Registration no: ACTRN12610000502033)
Appendix
Available only for authorised users
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Metadata
Title
How should we discuss genetic testing with women newly diagnosed with breast cancer? Design and implementation of a randomized controlled trial of two models of delivering education about treatment-focused genetic testing to younger women newly diagnosed with breast cancer
Authors
Kaaren J Watts
Bettina Meiser
Gillian Mitchell
Judy Kirk
Christobel Saunders
Michelle Peate
Jessica Duffy
Patrick J Kelly
Margaret Gleeson
Kristine Barlow-Stewart
Belinda Rahman
Michael Friedlander
Kathy Tucker
for the TFGT Collaborative Group
Publication date
01-12-2012
Publisher
BioMed Central
Published in
BMC Cancer / Issue 1/2012
Electronic ISSN: 1471-2407
DOI
https://doi.org/10.1186/1471-2407-12-320

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