Educational Materials for Genetic Testing in Cancer Patients

This study is developing and testing new educational materials about genetic testing for people with breast, ovarian, prostate, or pancreatic cancer. Researchers want to make these materials helpful for a diverse group of patients. You might receive updated educational materials (LCAM intervention) and genetic counseling through video calls, or standard genetic counseling through video calls. The study aims to see if the new materials lead to better decisions and satisfaction with genetic testing and counseling. Researchers will measure how many patients complete an interview and how satisfied they are with their genetic test decision and counseling. This study is currently unclear on its recruitment status, and plans to enroll 445 participants.

Study design
This interventional study is designed in two phases. Phase 1 involves formative research, and Phase 2 is a randomized clinical trial comparing two approaches to genetic testing education.
What's involved
In Phase 1, you would complete a cognitive interview. In Phase 2, you would receive either adapted pretest educational materials and post-test genetic counseling, or in-depth pre-test and post-test genetic counseling.
Compensation
Not stated in the trial record.
Follow-up
Your satisfaction with genetic test decisions and genetic counseling will be measured at 6 months.

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NCT04751435

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

Recruiting
NAAges 18+InterventionalHealth services
Memorial Sloan Kettering Cancer Center
~445 participants
Updated 2026-07-21 on ClinicalTrials.gov
What's tested:Cognitive interviewLCAM interventionStandard of care

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of patients who complete the cognitive interview (Phase I)
Measured over 1 year
+2 more outcomes measured
Educational Materials for Genetic Testing
Breast Cancer
Ovarian Cancer
Prostate Cancer
Pancreatic Cancer
Colorectal Cancer
4 sites across 1 states
New York4
  • Jada Hamilton, PhD, MPH · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

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Eligibility criteria

Inclusion

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.
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 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:
Pancreatic cancer criteria:
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

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".
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".
  • Number of patients who complete the cognitive interview (Phase I)1 year

    the number of patients who complete the cognitive interview

  • Genetic test decision (Phase II) satisfaction6 months

    is measured with the validated Satisfaction with Decisions scale.

  • Genetic counseling satisfaction (Phase II)6 months

    is measured with the validated Genetic Counseling Satisfaction scale