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Developing New Educational Materials About Genetic Testing for a Diverse Group of Cancer Patients

Sponsor: Memorial Sloan Kettering Cancer Center • ClinicalTrials.gov ID: NCT04751435

Registry updated: 2026-10-05

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Description

Genetic testing is a type of test that detects changes to the genes-the DNA instructions that are passed on from the mother and father. The results of a genetic test can confirm whether the participant has a genetic disorder, which is a disease caused in whole or in part by changes to the genes. Genetic testing can also help determine a person's chance of getting or passing on a genetic disorder. Genetic tests use a sample of blood, hair, skin, or other tissue, and they can look at one gene or multiple genes at the same time. Genetic testing may change the options for treating people with certain types of cancer. For example, some medications are more helpful for the treatment of cancer in people with certain gene changes (mutations). The researchers are doing this study to develop new educational materials about genetic testing for people who speak different languages and have diverse cultural and educational backgrounds. During the study, the staff will interview participants with diverse cultural and educational backgrounds and ask them to review a sample of the educational materials that have been developed so far. Participants will give their opinions on these materials, and the researchers will use participants' feedback to improve the materials.

Interventions

Cognitive interview (Other)
Researchers will use formative methods to adapt our previously-developed mainstreaming pre-genetic test educational materials plus standard post-test clinical communication materials used by the MSK CGS for use with the diverse patients. Specifically, it will adapt these materials to be responsive to patients' linguistic and literacy needs, and sensitive to their cultural diversity.
LCAM intervention (Behavioral)
Participants will receive adapted pretest educational materials from study staff and/or clinical staff and have testing ordered by their oncologist, followed by post-test genetic counseling via telegenetics with a health and genetic "literacy screener" and adapted clinical communication materials.
Standard of care (Behavioral)
Participants will receive in-depth pre-test and post-test genetic counseling provided via telegenetics

Eligibility criteria

Inclusion Criteria: Phase 1 * Age ≥ 18 years as per self-report * Current or previous diagnosis of breast, ovarian, pancreatic, or prostate cancer as per self-report * Self-identification as Black, Latino, and/or neither Black nor Latino (i.e.,non-Latino, Non black) * Fluency in English, Haitian Creole, or Spanish as per self-report (for Spanish, we will attempt to recruit a cohort representing a variety of regions where Spanish is spoken, as informed by current data from participating sites, to achieve neutrality in the language) Fluency is defined as an answer of "well" or "very well" on the screening questions for spoken and reading ability. Phase 2: * Age ≥ 18 years as per the medical record and/or clinician referral * Current or previous diagnosis of breast, colorectal, ovarian, pancreatic, or prostate cancer meeting at least one of the applicable criteria for the cancer type as per the medical record and/or clinician referral: * Breast cancer criteria: * any diagnosis age 65 or younger; * diagnosis of triple negative breast cancer at any age; * multiple primary breast cancers at any age; * under consideration for PARP therapy; * any family history (1st, 2nd, or 3rd degree relatives) of ovarian or pancreas cancer, or 1 relative with breast cancer who meets the above criteria, or 2 relatives with breast cancer at any age; or clinician discretion) * colorectal cancer * Ovarian cancer criteria: * invasive ovarian cancer * Pancreatic cancer criteria: * pancreatic adenocarcinoma * Prostate cancer criteria: * castrate-resistant, metastatic prostate cancer; * high-risk prostate cancer (pending pathology definition) * Fluency in English, Haitian Creole, or Spanish as per self-report. Fluency is defined as an answer of "well" or "very well" on the screening questions for spoken ability * No prior cancer genetic counseling or germline testing for cancer risk as per self-report clinician's note, and/or no clinical documentation Exclusion Criteria: Phase 1: * Individuals of impaired decision-making capacity as per a clinician's or consenting professional's judgment. * Subjects who indicate level of fluency as "not at all" or "not well". Phase 2: * Individuals of impaired decision-making capacity as per a clinician's or consenting professional's judgment. * Subjects who indicate level of fluency as "not at all" or "not well".

Conditions

Educational Materials for Genetic Testing Breast Cancer Ovarian Cancer Prostate Cancer Pancreatic Cancer Colorectal Cancer

Locations

Kings County Hopsital Center — Brooklyn, New York, United States
Queens Cancer Center of Queens Hospital — Jamaica, New York, United States
Memorial Sloan Kettering at Ralph Lauren Center (Limited Protocol Activities) — New York, New York, United States
Jamaica Hospital Medical Center (Data Collection Only) — Richmond Hill, New York, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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