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

Sponsor
Memorial Sloan Kettering Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04751435
Collaborator
(none)
125
Enrollment
2
Locations
53.8
Anticipated Duration (Months)
62.5
Patients Per Site
1.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Other: Cognitive interview

Study Design

Study Type:
Observational
Anticipated Enrollment :
125 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Feb 5, 2021
Anticipated Primary Completion Date :
Aug 1, 2025
Anticipated Study Completion Date :
Aug 1, 2025

Arms and Interventions

ArmIntervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Number of patients who complete the cognitive interview [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Exclusion Criteria:
  • Individuals of impaired decision-making capacity as per a clinician's judgment.

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Kings County Hopsital CenterBrooklynNew YorkUnited States11203
2Queens Cancer Center of Queens HospitalJamaicaNew YorkUnited States11432

Sponsors and Collaborators

  • Memorial Sloan Kettering Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT04751435
Other Study ID Numbers:
  • 20-458
First Posted:
Feb 12, 2021
Last Update Posted:
Oct 7, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Memorial Sloan Kettering Cancer Center

Study Results

No Results Posted as of Oct 7, 2021