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Open Access Highly Accessed 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

Kaaren J Watts12*, Bettina Meiser12, Gillian Mitchell3, Judy Kirk45, Christobel Saunders6, Michelle Peate12, Jessica Duffy1, Patrick J Kelly7, Margaret Gleeson18, Kristine Barlow-Stewart9, Belinda Rahman1, Michael Friedlander12, Kathy Tucker1 and for the TFGT Collaborative Group

Author Affiliations

1 Department of Medical Oncology, Prince of Wales Hospital, High Street, Randwick, NSW, 2031, Australia

2 Prince of Wales Clinical School, Faculty of Medicine, University of New South Wales, Kensington, NSW, 2052, Australia

3 Peter MacCallum Cancer Centre, Familial Cancer Service, Locked Bag 1, A'Beckett Street, East Melbourne, VIC, 8006, Australia

4 Familial Cancer Service, Westmead Hospital, Hawkesbury Road, Westmead, NSW, 2145, Australia

5 Westmead Millennium Institute for Medical Research at the University of Sydney, PO Box 412, Westmead, NSW, 2145, Australia

6 Department of Surgery, University of Western Australia, 35 Stirling Highway, Crawley, WA, 6009, Australia

7 School of Public Health, The University of Sydney, Edward Ford Building, Sydney, NSW, 2006, Australia

8 Hunter Family Cancer Service, PO Box 84, Waratah, NSW, 2298, Australia

9 Centre for Genetics Education, PO Box 317, St Leonards, NSW, 1590, Australia

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BMC Cancer 2012, 12:320  doi:10.1186/1471-2407-12-320

Published: 28 July 2012

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)

Keywords:
Breast cancer; Genetic testing; BRCA1; BRCA2; Treatment; Clinical practice