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

Breast Cancer Clinical Trial

— IMAGINE  

Official title:

IMAGINE: IMproving Access to Genetic INformation for Everyone - A Prospective Trial of a Linguistically and Culturally Appropriate Mainstreaming Model for Hereditary Cancer Multigene Panel Testing Among Diverse Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04751435
• Other study ID #: 20-458
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2021
• Est. completion date: August 31, 2026

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Jada Hamilton, PhD, MPH
• Phone: 646-888-0049
• Email: hamiltoj[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 625
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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".

Related Conditions & MeSH terms

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

Intervention

Other:
• Cognitive interview
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.

Locations

Country	Name	City	State
United States	Kings County Hopsital Center	Brooklyn	New York
United States	Queens Cancer Center of Queens Hospital	Jamaica	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who complete the cognitive interview		1 year

External Links

•   Memorial Sloan Kettering Cancer Center