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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Pancreatic Cancer; Ovarian Cancer; Prostate Cancer; Educational Materials for Genetic Testing
• Intervention / Treatment: Other: Cognitive interview

Detailed 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 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.

• Study Type: Interventional
• Enrollment (Estimated): 625
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jennifer Hay, PhD; Phone Number: 646-888-0039
• Study Contact Backup: Name: Jada Hamilton, PhD, MPH; Phone Number: 646-888-0049; Email: hamiltoj@mskcc.org

Study Locations

• United States
  • New York
    • Brooklyn, New York, United States, 11203
      • Recruiting
      • Kings County Hopsital Center
      • Contact: Jason Gonsky, MD; Phone Number: 718-245-2847
    • Jamaica, New York, United States, 11432
      • Recruiting
      • Queens Cancer Center of Queens Hospital
      • Contact: Margaret Kemeny, MD; Phone Number: 718-883-4031

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Study Population

Self-identification as Black, Latino, and/or neither Black nor Latino (i.e.,non-Latino, non black) Fluency in English, Haitian Creole, or Spanish. Patients will also be recruited from the clinics' waiting room by our study staff and through pre-screening of upcoming clinic visits.

Description

Inclusion Criteria:

• 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:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Breast,Ovarian, Prostate & Pancreatic Cancer; There is no treatment or intervention for Phase 1 of this study. Participants will be asked to participate in a cognitive interview. This section will be amended to include the Phase 2 intervention information once the Phase 1 portion of the study is complete. The Phase 1 materials developed, and results obtained, will directly be part of and inform the intervention for Phase 2.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients who complete the cognitive interview	1 year

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Jada Hamilton, PhD, MPH, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2021
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: February 8, 2021
• First Submitted That Met QC Criteria: February 8, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Genetic Testing; Hereditary Cancer; Educational Materials; Diverse Cancer Patients; 20-458
• Other Study ID Numbers: 20-458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No