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NCT04751435Recruiting

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

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

Source: ClinicalTrials.gov · Last updated 5 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
445 (estimated)
First submitted
8 Feb 2021
Start date
16 Nov 2021
Primary completion date
31 Aug 2027
Lead sponsor
Memorial Sloan Kettering Cancer Center
NCT number
NCT04751435

What you commit to

  • Study type: Interventional
  • Planned participants: 445
  • From 16 Nov 2021 to the primary completion date, 31 Aug 2027
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • 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".

Who the study is looking for

  • 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
  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kings County Hopsital Center
Coordinator of this site? Confirm its status
BrooklynUnited StatesRecruiting
Queens Cancer Center of Queens Hospital
Coordinator of this site? Confirm its status
JamaicaUnited StatesRecruiting
Memorial Sloan Kettering at Ralph Lauren Center (Limited Protocol Activities)
Coordinator of this site? Confirm its status
New YorkUnited StatesRecruiting
Jamaica Hospital Medical Center (Data Collection Only)
Coordinator of this site? Confirm its status
Richmond HillUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.