Pilot Trial of Streamlined Genetic Education and Traceback Genetic Testing in Prostate Cancer Survivors
Jess and Mildred Fisher Center for Hereditary Cancer and Clinical Genomics Research, Georgetown University, Washington, DC
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Jess and Mildred Fisher Center for Hereditary Cancer and Clinical Genomics Research, Georgetown University, Washington, DC
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Jess and Mildred Fisher Center for Hereditary Cancer and Clinical Genomics Research, Georgetown University, Washington, DC
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Jess and Mildred Fisher Center for Hereditary Cancer and Clinical Genomics Research, Georgetown University, Washington, DC
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Jess and Mildred Fisher Center for Hereditary Cancer and Clinical Genomics Research, Georgetown University, Washington, DC
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Jess and Mildred Fisher Center for Hereditary Cancer and Clinical Genomics Research, Georgetown University, Washington, DC
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Jess and Mildred Fisher Center for Hereditary Cancer and Clinical Genomics Research, Georgetown University, Washington, DC
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Jess and Mildred Fisher Center for Hereditary Cancer and Clinical Genomics Research, Georgetown University, Washington, DC
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Background: Germline genetic testing is recommended for men with metastatic or high-risk prostate cancer to inform treatment and risk management for other cancers and inform genetic testing in at-risk relatives. However, relatively few patients with prostate cancer undergo genetic testing. Given the low rate of testing and increasing demands on genetic service providers, strategies are needed that reduce barriers to testing while conserving genetic counseling resources. The primary goal of this study was to determine whether a proactive and streamlined “traceback” approach could yield increased genetic testing participation among prostate cancer survivors. Methods: We randomized 107 survivors of metastatic and high-risk prostate cancer to streamlined testing (ST) versus enhanced usual care (EUC). ST participants were proactively provided with print genetic education materials and the option to proceed to genetic testing without pre-test genetic counseling. EUC participants were sent a letter from their physician advising them of their eligibility for genetic testing and recommending they schedule genetic counseling. The primary outcome was genetic testing participation. Secondary outcomes were distress, knowledge, decision satisfaction, and regret. Results: In the ST group, 41.5% of participants completed genetic testing compared with 27.8% in the EUC group. After adjusting for education and marital status, the odds of testing were more than twice as high for the ST group as for the EUC group (odds ratio, 2.57; 95% CI, 1.05–6.29). The groups did not differ on any of the psychosocial outcomes at the 3-month follow-up. Conclusions: Proactive outreach paired with streamlined genetic testing delivery may be a safe, effective, and resource-efficient approach to facilitate traceback genetic testing in prostate cancer survivors.
Submitted March 2, 2023; final revision received July 26, 2023; accepted for publication August 16, 2023.
Author contributions: Conceptualization: Schwartz, Peshkin, Isaacs, Collins, Dawson, Okobi, Newell, Kolla, Weinstein. Data curation: Schwartz, Grisham, Holmes, Sorgen, Collins, Dawson, McGuire. Formal analysis: Schwartz, Okobi. Funding acquisition: Schwartz. Investigation: Schwartz, Peshkin, Issacs, Holmes, Sorgen, McGuire, Newell, Kolla, Weinstein. Methodology: Schwartz, Peshkin, Isaacs, Okobi, Newell, Kolla. Project administration: Peshkin, Grisham, Holmes, Sorgen, McGuire. Resources: Schwartz, Issacs, Collins, Dawson. Supervision: Schwartz, Peshkin, Sorgen, McGuire. Validation: Holmes, Sorgen. Writing—original draft: Schwartz, Peshkin, Grisham. Writing—review & editing: All authors.
Disclosures: Dr. Isaacs has disclosed receiving institutional funding from GSK, Seagen, Pfizer, AstraZeneca, Bristol Myers Squibb, Genentech, and Novartis; serving as a consultant for Genentech, Puma Biotechnology, Inc., Seagen, AstraZeneca, Novartis, Pfizer, and Gilead Sciences, Inc.; and serving on a data safety monitoring board for Novartis. The remaining authors have disclosed that they have not received any financial consideration from any person or organization to support the preparation, analysis, results, or discussion of this article.
Funding: Research reported in this publication was supported by the Jess and Mildred Fisher Center for Hereditary Cancer and Clinical Genomics Research (M.D. Schwartz), and the National Cancer Institute of the National Institutes of Health under award number P30CA051008.
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
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