NCT04751435 Developing New Educational Materials About Genetic Testing for a Diverse Group of Cancer Patients

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This trial targets 445 participants in total. It began in 2021-11-16 with a primary completion date of 2026-08-31.

Brief Summary

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.

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 * 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 criteria: * any diagnosis age 50 and below; * mismatch repair deficient colorectal cancer; * colorectal cancer at any age with an additional Lynch syndromerelated primary cancer at any age; * colorectal cancer at any age with a 1st or 2nd degree relative with colorectal cancer at/before age 50; * colorectal cancer at any age with 2 or more 1st or 2nd degree relatives with a Lynch syndrome-related cancer at any age * 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".

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