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
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
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.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.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.
- University of Melbourne Australia
- Westmead Hospital Australia
- Prince of Wales Hospital Australia
- University of Queensland Australia
- University of Queensland Australia
Comparative Effectiveness Research, Cancer Research, Genetic testing, Genes, BRCA2, Genes, BRCA1, TFGT Collaborative Group, 32 Biomedical and Clinical Sciences, anzsrc-for: 4202 Epidemiology, Clinical practice, <it>BRCA1</it>, Study Protocol, Breast cancer, 7.1 Individual care needs, Clinical Protocols, <it>BRCA</it>2, 1306 Cancer Research, RC254-282, Cancer, anzsrc-for: 42 Health Sciences, ccccBRCA2, Age Factors, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Health Services, 4203 Health Services and Systems, Ovarian Cancer, Health Disparities, anzsrc-for: 4203 Health Services and Systems, Oncology, 2730 Oncology, Female, anzsrc-for: 1117 Public Health and Health Services, Clinical Trials and Supportive Activities, 610, Breast Neoplasms, Genetic Counseling, 7.3 Management and decision making, Rare Diseases, anzsrc-for: 32 Biomedical and Clinical Sciences, 1311 Genetics, Clinical Research, Breast Cancer, Behavioral and Social Science, 616, Genetics, Humans, Genetic Testing, anzsrc-for: 3211 Oncology and Carcinogenesis, Prevention, anzsrc-for: 1112 Oncology and Carcinogenesis, 42 Health Sciences, 3211 Oncology and Carcinogenesis, BRCA1, BRCA2, Treatment, Cost Effectiveness Research, Genes, Mutation, Women's Health
Comparative Effectiveness Research, Cancer Research, Genetic testing, Genes, BRCA2, Genes, BRCA1, TFGT Collaborative Group, 32 Biomedical and Clinical Sciences, anzsrc-for: 4202 Epidemiology, Clinical practice, <it>BRCA1</it>, Study Protocol, Breast cancer, 7.1 Individual care needs, Clinical Protocols, <it>BRCA</it>2, 1306 Cancer Research, RC254-282, Cancer, anzsrc-for: 42 Health Sciences, ccccBRCA2, Age Factors, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, Health Services, 4203 Health Services and Systems, Ovarian Cancer, Health Disparities, anzsrc-for: 4203 Health Services and Systems, Oncology, 2730 Oncology, Female, anzsrc-for: 1117 Public Health and Health Services, Clinical Trials and Supportive Activities, 610, Breast Neoplasms, Genetic Counseling, 7.3 Management and decision making, Rare Diseases, anzsrc-for: 32 Biomedical and Clinical Sciences, 1311 Genetics, Clinical Research, Breast Cancer, Behavioral and Social Science, 616, Genetics, Humans, Genetic Testing, anzsrc-for: 3211 Oncology and Carcinogenesis, Prevention, anzsrc-for: 1112 Oncology and Carcinogenesis, 42 Health Sciences, 3211 Oncology and Carcinogenesis, BRCA1, BRCA2, Treatment, Cost Effectiveness Research, Genes, Mutation, Women's Health
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