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
1 other identifier
interventional
445
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2021
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 8, 2021
CompletedFirst Posted
Study publicly available on registry
February 12, 2021
CompletedStudy Start
First participant enrolled
November 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
October 21, 2025
October 1, 2025
4.8 years
February 8, 2021
October 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of patients who complete the cognitive interview (Phase I)
the number of patients who complete the cognitive interview
1 year
Genetic test decision (Phase II) satisfaction
is measured with the validated Satisfaction with Decisions scale.
6 months
Genetic counseling satisfaction (Phase II)
is measured with the validated Genetic Counseling Satisfaction scale
6 months
Study Arms (3)
Cognitive interview intervention for Phase 1
EXPERIMENTALThere 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.
Standard of care (Phase II only randomization)
ACTIVE COMPARATORParticipants will receive in-depth pre-test and post-test genetic counseling provided via telegenetics
LCAM Intervention (Phase II only randomization)
ACTIVE COMPARATORParticipants 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.
Interventions
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.
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.
Participants will receive in-depth pre-test and post-test genetic counseling provided via telegenetics
Eligibility Criteria
You may qualify if:
- 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.
- Phase 2:
- Age ≥ 18 years as per the medical record
- Current or previous diagnosis of breast, colorectal, ovarian, pancreatic, or prostate cancer meeting at least one of the applicable criteria for the cancer type as per the medical record and/or clinician referral:
- Breast cancer criteria:
- any diagnosis age 65 or younger;
- diagnosis of triple negative breast cancer at any age;
- multiple primary breast cancers at any age;
- under consideration for PARP therapy;
- any family history (1st, 2nd, or 3rd degree relatives) of ovarian or pancreas cancer, or 1 relative with breast cancer who meets the above criteria, or 2 relatives with breast cancer at any age; or clinician discretion)
- Colorectal cancer criteria:
- +14 more criteria
You may not qualify if:
- 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".
- Phase 2:
- 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".
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Kings County Hopsital Center
Brooklyn, New York, 11203, United States
Queens Cancer Center of Queens Hospital
Jamaica, New York, 11432, United States
Memorial Sloan Kettering at Ralph Lauren Center (Limited Protocol Activities)
New York, New York, 10035, United States
Jamaica Hospital Medical Center (Data Collection Only)
Richmond Hill, New York, 11418, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jada Hamilton, PhD, MPH
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 8, 2021
First Posted
February 12, 2021
Study Start
November 16, 2021
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
October 21, 2025
Record last verified: 2025-10
Data Sharing
- IPD Sharing
- Will share
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.