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; Colorectal Cancer; Pancreatic Cancer; Ovarian Cancer; Prostate Cancer; Educational Materials for Genetic Testing
• Intervention / Treatment: Other: Cognitive interview; Behavioral: Standard of care; Behavioral: LCAM intervention

Detailed Description

The objective of this proposal is to develop, test and evaluate a mainstreaming (LCAM) model for hereditary cancer multigene panel testing (MGPT) among many different types of cancer patients. 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. 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 useful for patients of many different backgrounds. 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 patients treated at local community hospitals. Patients diagnosed with breast, colorectal, ovarian, pancreatic, or prostate cancer 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 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 be followed prospectively and will complete assessments consisting of validated and investigator-designed measures. Phase 2 primary outcomes include genetic test decision satisfaction and genetic counseling satisfaction. Secondary outcomes include additional decision-making, psychosocial, and behavioral outcomes.

For Phase 2, participants will be recruited from our partnering sites, which include Kings County Hospital Center, Queens Cancer Center, Jamaica Hospital Medical Center, and the MSK Ralph Lauren Center for Cancer Care. Study staff will identify eligible patients from review of clinic lists and patient medical records, and will also receive direct study referrals from clinicians located at the partnering sites. Study staff will approach eligible patients in order to describe the study, screen them for eligibility (including assessing language proficiency via self-report and prior experience with cancer genetic counseling/testing), and obtain informed consent and collect their contact information.

• Study Type: Interventional
• Enrollment (Estimated): 445
• 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: Linda Bulone, RN, OCN, CCRC; Phone Number: (718) 883-2958
    • New York, New York, United States, 10035
      • Recruiting
      • Memorial Sloan Kettering at Ralph Lauren Center (Limited Protocol Activities)
      • Contact: Jada Hamilton, PhD, MPH; Phone Number: 646-888-0049
    • Richmond Hill, New York, United States, 11418
      • Recruiting
      • Jamaica Hospital Medical Center (Data Collection Only)
      • Contact: Rosa Nouvini, MD; Phone Number: 718-206-6000

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:

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:

  • any diagnosis age 50 and below;
  • mismatch repair deficient colorectal cancer;
  • colorectal cancer at any age with an additional Lynch syndromerelated primary cancer at any age;
  • colorectal cancer at any age with a 1st or 2nd degree relative with colorectal cancer at/before age 50;
  • colorectal cancer at any age with 2 or more 1st or 2nd degree relatives with a Lynch syndrome-related cancer at any age

• Ovarian cancer criteria:

  ° invasive ovarian cancer

• Pancreatic cancer criteria:

  ° pancreatic adenocarcinoma

• Prostate cancer criteria:

  • castrate-resistant, metastatic prostate cancer;
  • high-risk prostate cancer (pending pathology definition)
• Fluency in English, Haitian Creole, or Spanish as per self-report. Fluency is defined as an answer of "well" or "very well" on the screening questions for spoken ability
• No prior cancer genetic counseling or germline testing for cancer risk as per self-report clinician's note, and/or no clinical documentation

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".

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".

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
Active Comparator: Standard of care (Phase II only randomization); Participants will receive in-depth pre-test and post-test genetic counseling provided via telegenetics	Behavioral: Standard of care; 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.	Behavioral: LCAM intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

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 (Estimated): October 21, 2025
• Last Update Submitted That Met QC Criteria: October 20, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Colorectal Cancer; Genetic Testing; Hereditary Cancer; Educational Materials; Diverse Cancer Patients; 20-458
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Endocrine System Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Genital Diseases, Female; Endocrine Gland Neoplasms; Pancreatic Diseases; Colonic Diseases; Ovarian Diseases; Adnexal Diseases; Genital Neoplasms, Female; Gonadal Disorders; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Prostatic Neoplasms; Colorectal Neoplasms; Ovarian Neoplasms; Breast Neoplasms; Pancreatic Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• 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
• product manufactured in and exported from the U.S.: No