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USClinicalTrials.govClinical trialNot applicableRecruiting

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

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Official record

Identifier
NCT04751435
Recruiting locations

country

United States
Interventions studied
Cognitive interviewLCAM interventionStandard of care
Lead sponsor
Memorial Sloan Kettering Cancer Center
Target enrolment
445 participants
Study type
INTERVENTIONAL
Phase
Not applicable
Status
Recruiting
First posted
Feb 12, 2021
Last updated on the registry
Oct 1, 2026
Age
18 Years
Sex
ALL
Study contact
The official record lists a study contact. Contact details are published there and are intentionally not copied to this page.
Eligibility criteria

Reproduced verbatim from the official record. Eligibility is decided by the study team, never by this page.

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".
Indexed under
Breast Cancer