Status:
RECRUITING
Developing New Educational Materials About Genetic Testing for a Diverse Group of Cancer Patients
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Educational Materials for Genetic Testing
Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 participan...
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 cen...
Eligibility Criteria
Inclusion
- 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
- 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".
Key Trial Info
Start Date :
November 16 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
445 Patients enrolled
Trial Details
Trial ID
NCT04751435
Start Date
November 16 2021
End Date
August 31 2026
Last Update
October 21 2025
Active Locations (4)
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1
Kings County Hopsital Center
Brooklyn, New York, United States, 11203
2
Queens Cancer Center of Queens Hospital
Jamaica, New York, United States, 11432
3
Memorial Sloan Kettering at Ralph Lauren Center (Limited Protocol Activities)
New York, New York, United States, 10035
4
Jamaica Hospital Medical Center (Data Collection Only)
Richmond Hill, New York, United States, 11418