Creating educational materials about genetic testing for 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

This study is testing new educational materials about genetic testing for cancer to see if they help English, Haitian Creole, and Spanish-speaking patients make better decisions about their care.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 445 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Memorial Sloan Kettering Cancer Center (Academic / other)
• Locations: 4 sites (Brooklyn, New York and 3 other locations)
• Trial ID: NCT04751435 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with a current or previous diagnosis of breast, ovarian, pancreatic, or prostate cancer who identify as Black, Latino, or non-Latino/non-Black and are fluent in English, Haitian Creole, or Spanish.

Not a fit: Patients who do not have a diagnosis of the specified cancers or who are not fluent in the targeted languages may not benefit from this study.

Why it matters

Potential benefit: If successful, this initiative could enhance understanding and access to genetic testing for cancer patients, leading to better treatment decisions.

How similar studies have performed: While there have been studies focusing on genetic testing education, this approach of culturally tailored materials for diverse populations is relatively novel.

Eligibility criteria

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".

Where this trial is running

Brooklyn, New York and 3 other locations

• 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

Conditions Educational Materials for Genetic Testing; Breast Cancer; Ovarian Cancer; Prostate Cancer; Pancreatic Cancer; Colorectal Cancer; Educational Materials; Genetic Testing