Randomized trial promoting cancer genetic risk assessment when genetic counseling cost removed: 1-year follow-up

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dc.creatorAn, Jinghua
dc.creatorMcDougall, Jean
dc.creatorLin, Yong
dc.creatorLu, Shou-En
dc.creatorWalters, Scott T.
dc.creatorHeidt, Emily
dc.creatorStroup, Antoinette
dc.creatorPaddock, Lisa
dc.creatorGrumet, Sherry
dc.creatorToppmeyer, Deborah
dc.creatorKinney, Anita Y.
dc.creator.orcid0000-0003-4074-6141 (Walters, Scott T.)
dc.date.accessioned2024-05-30T16:50:38Z
dc.date.available2024-05-30T16:50:38Z
dc.date.issued2024-03-16
dc.description.abstractPURPOSE: Cancer genetic risk assessment (CGRA) is recommended for women with ovarian and high-risk breast cancer. However, the underutilization of CGRA has long been documented, and cost has been a major barrier. In this randomized controlled trial, a tailored counseling and navigation (TCN) intervention significantly improved CGRA uptake at 6-month follow-up, compared with targeted print (TP) and usual care (UC). We aimed to examine the effect of removing genetic counseling costs on CGRA uptake by 12 months. METHODS: We recruited racially and geographically diverse women with breast and ovarian cancer from cancer registries in Colorado, New Jersey, and New Mexico. Participants assigned to TCN received telephone-based psychoeducation and navigation. After 6 months, the trial provided free genetic counseling to participants in all arms. RESULTS: At 12 months, more women in TCN obtained CGRA (26.6%) than those in TP (11.0%; odds ratio [OR] = 2.77, 95% confidence interval [CI] = 1.56 to 4.89) and UC (12.2%; OR = 2.46, 95% CI = 1.41 to 4.29). There were no significant differences in CGRA uptake between TP and UC. The Kaplan-Meier curve shows that the divergence of cumulative incidence slopes (TCN vs UC, TCN vs TP) appears primarily within the initial 6 months. CONCLUSION: TCN significantly increased CGRA uptake at the 12-month follow-up. Directly removing the costs of genetic counseling attenuated the effects of TCN, highlighting the critical enabling role played by cost coverage. Future policies and interventions should address multilevel cost-related barriers to expand patients' access to CGRA. TRIAL REGISTRATION: This trial was registered with the NIH clinical trial registry, clinicaltrials.gov, NCT03326713. https://clinicaltrials.gov/ct2/show/NCT03326713.
dc.description.sponsorshipThis work was supported by the National Cancer Institute of the National Institutes of Health (R01CA211625 to AYK), the Rutgers Cancer Institute of New Jersey Comprehensive Cancer Center core grant from the National Cancer Institute (NIH/NCI, 3P30CA072720) including the use of the Biostatistics Shared Resource and the University of New Mexico Comprehensive Cancer Center core grant from the National Cancer Institute (NIH/NCI P30CA118100) including use of the services provided by the Behavioral Measurement and Population Sciences (BMPS) and Biostatistics Shared Resources. Support is also provided by the New Jersey State Cancer Registry, Cancer Epidemiology Services, New Jersey Department of Health, funded by the National Cancer Institute's Surveillance, Epidemiology and End Results (SEER) Program (#75N91021D00009), Centers for Disease Control and Prevention's National Program of Cancer Registries (#5NU58DP006279) with additional support from the State of New Jersey and the Rutgers Cancer Institute of New Jersey; New Mexico Tumor Registry, contract number HHSN261201800014I; Task Order HHSN26100001 from the National Cancer Institute; and the Colorado Cancer Registry, cooperative agreement NU58DP006347-02 from the CDC, with data collected and provided, in part, by the Colorado Central Cancer Registry (CCCR), a participating registry in the National Program of Cancer Registries (NPCR), CDC, cooperative agreement number 5 NU58DP006347. Study data were collected and managed using REDCap electronic data capture tools hosted at the University of New Mexico and the Rutgers Cancer Institute of New Jersey.
dc.identifier.citationAn, J., McDougall, J., Lin, Y., Lu, S. E., Walters, S. T., Heidt, E., Stroup, A., Paddock, L., Grumet, S., Toppmeyer, D., & Kinney, A. Y. (2024). Randomized trial promoting cancer genetic risk assessment when genetic counseling cost removed: 1-year follow-up. JNCI cancer spectrum, 8(2), pkae018. https://doi.org/10.1093/jncics/pkae018
dc.identifier.issn2515-5091
dc.identifier.issue2
dc.identifier.urihttps://hdl.handle.net/20.500.12503/32818
dc.identifier.volume8
dc.publisherOxford University Press
dc.relation.urihttps://doi.org/10.1093/jncics/pkae018
dc.rights.holder© The Author(s) 2024.
dc.rights.licenseAttribution 4.0 International (CC BY 4.0 Deed)
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/
dc.sourceJNCI Cancer Spectrum
dc.subject.meshGenetic Counseling
dc.subject.meshOvarian Neoplasms / genetics
dc.titleRandomized trial promoting cancer genetic risk assessment when genetic counseling cost removed: 1-year follow-up
dc.typeArticle
dc.type.materialtext

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