Recruiting

Genetic Testing

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT04751435

Conditions

Educational Materials for Genetic Testing

Breast Cancer

Ovarian Cancer

Prostate Cancer

Pancreatic Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cognitive interview

LCAM intervention

Standard of care

Study Details

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.

Conditions

Educational Materials for Genetic Testing

Breast Cancer

Ovarian Cancer

Prostate Cancer

Pancreatic Cancer

Study ID

NCT04751435

Start date

Nov 16, 2021

Status verified date

Jul, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 and/or clinician referral
  • 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 Design

Enrollment

445 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

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.

Interventions

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.

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.

Standard of care

Participants will receive in-depth pre-test and post-test genetic counseling provided via telegenetics

Primary outcome measure

  • Number of patients who complete the cognitive interview (Phase I) [ Time Frame: 1 year ]
  • Genetic test decision (Phase II) satisfaction [ Time Frame: 6 months ]
  • Genetic counseling satisfaction (Phase II) [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Jada Hamilton, PhD, MPH

646-888-0049hamiltoj@mskcc.org

Jennifer Hay, PhD

646-888-0039

Locations

Kings County Hopsital Center

Recruiting

Brooklyn, New York, United States, 11203

Contacts

Jason Gonsky, MD

718-245-2847

Queens Cancer Center of Queens Hospital

Recruiting

Jamaica, New York, United States, 11432

Contacts

Linda Bulone, RN, OCN, CCRC

(718) 883-2958

Memorial Sloan Kettering at Ralph Lauren Center (Limited Protocol Activities)

Recruiting

New York, New York, United States, 10035

Contacts

Jada Hamilton, PhD, MPH

646-888-0049

Jamaica Hospital Medical Center (Data Collection Only)

Recruiting

Richmond Hill, New York, United States, 11418

Contacts

Rosa Nouvini, MD

718-206-6000

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Jul 21, 2026

Last verified

Jul, 2026

Keywords

  • Educational Materials
  • Genetic Testing
  • Hereditary Cancer
  • Diverse Cancer Patients
  • Colorectal Cancer
  • 20-458

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-07-21.