Breast Cancer Clinical Trial

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

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.

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Full Description

The objective of this proposal is to develop, test and evaluate a linguistically and culturally appropriate mainstreaming (LCAM) model for hereditary cancer multigene panel testing (MGPT) among cancer patients diverse in race/ethnicity, language, and education. The central hypothesis is that this LCAM genetic testing model will lead to better patient decision-making, psychosocial, and behavioral outcomes than a traditional model of genetic services represented by our standard-of-care arm. Breast, ovarian, pancreatic, and prostate cancer patients diverse in race/ethnicity, language (English, Haitian, Creole, and Spanish), and education will be recruited from partnering New York City community hospitals including Kings County Hospital and Queens Cancer Center. In Phase 1, the researchers will first conduct formative research including transcreation and cognitive interviewing to adapt our existing educational materials (brochure and video) and clinical communication materials (clinic visit summary and family dissemination messaging) for the LCAM model to be linguistically tailored to English, Haitian Creole, and Spanish-speaking patients, culturally sensitive to perspectives of Black and Latino patients, and inclusive of needs of patients with lower educational attainment. In Phase 2, the researchers will conduct a randomized clinical trial (RCT) to test and evaluate effects of the LCAM model for hereditary cancer MGPT as compared to standard-of-care among the diverse patients treated at the KCHC and QCC community hospitals. Patients diagnosed with breast, colorectal, ovarian, pancreatic, or prostate cancer. Patients will be offered hereditary cancer MGPT through either: i) standard-of-care wherein in-depth pre-test and post-test genetic counseling are provided via telegenetics (videoconferencing), or ii) LCAM intervention wherein patients receive adapted pretest educational materials and have testing ordered by their oncologist, followed by post-test genetic counseling via telephone with a health and genetic "literacy screener" and adapted clinical communication materials. Participants will be followed prospectively and will complete assessments consisting of validated and investigator-designed measures.

Primary outcomes include genetic test decision satisfaction and genetic counseling satisfaction and genetic counseling- satisfaction. Secondary outcomes include additional decision-making, psychosocial, and behavioral outcomes. The information in the ClinicalTrials.gov reflects the Phase 1 work only. The protocol and ClinicalTrials.gov record will be updated to reflect the Phase 2 work when this phase is ready to commence.

View Eligibility Criteria

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.

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".

Study is for people with:

Breast Cancer

Estimated Enrollment:

625

Study ID:

NCT04751435

Recruitment Status:

Recruiting

Sponsor:

Memorial Sloan Kettering Cancer Center

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There are 2 Locations for this study

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Kings County Hopsital Center
Brooklyn New York, 11203, United States More Info
Jason Gonsky, MD
Contact
718-245-2847
Queens Cancer Center of Queens Hospital
Jamaica New York, 11432, United States More Info
Linda Bulone, RN, OCN, CCRC
Contact
(718) 883-2958

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

625

Study ID:

NCT04751435

Recruitment Status:

Recruiting

Sponsor:


Memorial Sloan Kettering Cancer Center

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