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

Part of paid clinical trials in Brooklyn, New York.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04751435
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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

Study Details

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.

Key Dates

Start date
Nov 16, 2021
Status verified
Oct 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
445 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Cognitive interview intervention for Phase 1
    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.Phase 2: participants will be randomized to the standard-of-care arm or the LCAM intervention arm.
  • Active Comparator: Standard of care (Phase II only randomization)
    Participants will receive in-depth pre-test and post-test genetic counseling provided via telegenetics
  • Active Comparator: LCAM Intervention (Phase II only randomization)
    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.

Primary Outcome Measure

Number of patients who complete the cognitive interview (Phase I) [ Time Frame: 1 year ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Kings County Hopsital CenterBrooklynNew York11203
Jason Gonsky, MD
718-245-2847
Queens Cancer Center of Queens HospitalJamaicaNew York11432
Linda Bulone, RN, OCN, CCRC
(718) 883-2958
Memorial Sloan Kettering at Ralph Lauren Center (Limited Protocol Activities)New YorkNew York10035
Jada Hamilton, PhD, MPH
646-888-0049
Jamaica Hospital Medical Center (Data Collection Only)Richmond HillNew York11418
Rosa Nouvini, MD
718-206-6000

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