A pilot study of a digital, patient-directed consent process for MSK-IMPACT tumor-normal genetic testing in gynecologic cancer.

10604 Background: Although germline and somatic genetic testing is increasingly recommended for many cancers including gynecologic cancers, uptake remains low. Barriers include consenting processes that are time consuming for patients and providers. We sought to test uptake and acceptability of a digital, self-directed genetic testing consent process. Methods: We developed a digital, self-guided consenting process for MSK-IMPACT tumor-normal targeted sequencing called “read and sign” (R&S) that included an educational video and information about genetic testing along with a direct digital consent. We performed a pilot study in gynecologic surgery (GYNS) and medical oncology (GMO) clinics to evaluate the uptake of genetic testing and other metrics including time to consent, clinic time saved, and patient satisfaction. Briefly, adults with gynecologic cancers eligible for MSK-IMPACT were sent R&S consent via electronic health record. Research staff followed up with patients at 2, 7, and 14 days. If patients did not consent after 14 days, the clinical team was notified to follow-up. This study was approved under IRBs 12-245 and X25-012. Results: Between 10/6/2025 and 12/31/2025, we identified 173 patients (122 GYNS and 51 GMO) eligible for MSK-IMPACT and offered them R&S consent. This represented 8% of total MSK-IMPACT consents across the institution during this time. Median age was 61 years. 106 (61%) patients identified as White, 27 (16%) as Asian, 17 (10%) as Black, and 24 (14%) as Hispanic. Most common cancer types were endometrial (n=75, 43%) and ovarian (n=39, 23%). In GYNS, 102/122 (84%) patients consented with R&S, and 59 (58%) consented on the same day the R&S consent was sent. On average, 8 minutes of in-person clinic time per patient was saved using R&S, but 35 (29%) patients had 0 time saved, and 7 (7%) consents were later completed in-person after initial incomplete R&S attempt. One patient who completed the R&S consent later withdrew consent. In GMO, 50/51 (98%) patients consented via R&S, with 38 (76%) consented on the same day. On average, 14 minutes of clinic time per patient was saved, and 4 (8%) patients ultimately required in-person consent. Average time to consent was 3.3 days in GYNS and 1.7 days in GMO. Among 11 patients who completed surveys, 10 (91%) were very/somewhat satisfied with R&S. More in-depth surveys and semi-structured interviews with a subset of patients and staff are ongoing, and data will be forthcoming. Conclusions: A digital, self-guided consent for MSK-IMPACT genetic testing was feasible and acceptable with some differences in workflow between surgical and medical oncology clinics. The R&S consent process empowers patient decision-making and should be scaled to other cancer types.

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Publication Details

Journal
Journal of Clinical Oncology
Published
2026-05-27
DOI
https://doi.org/10.1200/jco.2026.44.16_suppl.10604
Primary Topic
BRCA gene mutations in cancer
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article
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article

A pilot study of a digital, patient-directed consent process for MSK-IMPACT tumor-normal genetic testing in gynecologic cancer.

Nicholas Cimaglia, Stephanie Terzulli, Tina Alano, D. Schrag et al.
Journal of Clinical Oncology
BRCA gene mutations in cancer
article

A pilot study of a digital, patient-directed consent process for MSK-IMPACT tumor-normal genetic testing in gynecologic cancer.

Nicholas Cimaglia, Stephanie Terzulli, Tina Alano, D. Schrag, Gabrielle Bennetti, Zsofia Kinga Stadler, Nancy Varice, Yue Liu, Liu Y, Nadeem Abu-Rustum, Collette Houston, Varshini Gali, Nour Kandil, Carol Aghajanian, Dominick Morrone, David B. Solit, Paul Sabbatini, Tamara Torres Polanco, Mikit Patel
article en

Abstract

10604 Background: Although germline and somatic genetic testing is increasingly recommended for many cancers including gynecologic cancers, uptake remains low. Barriers include consenting processes that are time consuming for patients and providers. We sought to test uptake and acceptability of a digital, self-directed genetic testing consent process. Methods: We developed a digital, self-guided consenting process for MSK-IMPACT tumor-normal targeted sequencing called “read and sign” (R&S) that included an educational video and information about genetic testing along with a direct digital consent. We performed a pilot study in gynecologic surgery (GYNS) and medical oncology (GMO) clinics to evaluate the uptake of genetic testing and other metrics including time to consent, clinic time saved, and patient satisfaction. Briefly, adults with gynecologic cancers eligible for MSK-IMPACT were sent R&S consent via electronic health record. Research staff followed up with patients at 2, 7, and 14 days. If patients did not consent after 14 days, the clinical team was notified to follow-up. This study was approved under IRBs 12-245 and X25-012. Results: Between 10/6/2025 and 12/31/2025, we identified 173 patients (122 GYNS and 51 GMO) eligible for MSK-IMPACT and offered them R&S consent. This represented 8% of total MSK-IMPACT consents across the institution during this time. Median age was 61 years. 106 (61%) patients identified as White, 27 (16%) as Asian, 17 (10%) as Black, and 24 (14%) as Hispanic. Most common cancer types were endometrial (n=75, 43%) and ovarian (n=39, 23%). In GYNS, 102/122 (84%) patients consented with R&S, and 59 (58%) consented on the same day the R&S consent was sent. On average, 8 minutes of in-person clinic time per patient was saved using R&S, but 35 (29%) patients had 0 time saved, and 7 (7%) consents were later completed in-person after initial incomplete R&S attempt. One patient who completed the R&S consent later withdrew consent. In GMO, 50/51 (98%) patients consented via R&S, with 38 (76%) consented on the same day. On average, 14 minutes of clinic time per patient was saved, and 4 (8%) patients ultimately required in-person consent. Average time to consent was 3.3 days in GYNS and 1.7 days in GMO. Among 11 patients who completed surveys, 10 (91%) were very/somewhat satisfied with R&S. More in-depth surveys and semi-structured interviews with a subset of patients and staff are ongoing, and data will be forthcoming. Conclusions: A digital, self-guided consent for MSK-IMPACT genetic testing was feasible and acceptable with some differences in workflow between surgical and medical oncology clinics. The R&S consent process empowers patient decision-making and should be scaled to other cancer types.

Journal of Clinical OncologyVol. 44(16_suppl)
Memorial Sloan Kettering Cancer Center (US), Cornell University (US), Presbyterian Hospital (US)
National Institutes of Health
Quality Education
Openalex Percentile: Top 6%
BRCA gene mutations in cancer
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