Creating educational materials about genetic testing for cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This project aims to develop and evaluate culturally and linguistically appropriate educational materials for genetic testing among cancer patients from diverse backgrounds. The researchers will conduct formative research to adapt existing materials for better understanding among English, Haitian Creole, and Spanish-speaking patients. A randomized clinical trial will then assess the effectiveness of these tailored materials compared to standard care. The goal is to improve patient decision-making and outcomes related to hereditary cancer testing.

Why it matters

Who can join: the full rules

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
* 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".

Where it's running

• Kings County Hopsital Center
  Brooklyn, New York, United States Recruiting
• Queens Cancer Center of Queens Hospital
  Jamaica, New York, United States Recruiting
• Memorial Sloan Kettering at Ralph Lauren Center (Limited Protocol Activities)
  New York, New York, United States Recruiting
• Jamaica Hospital Medical Center (Data Collection Only)
  Richmond Hill, New York, United States Recruiting

Study contacts

• Principal investigator: Jada Hamilton, PhD, MPH — Memorial Sloan Kettering Cancer Center
• Study coordinator: Jada Hamilton, PhD, MPH
• Email: hamiltoj@mskcc.org
• Phone: 646-888-0049

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.