Clinical trial NCT04751435: Developing New Educational Materials About Genetic Testing for a Diverse Group of Cancer Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Educational Materials for Genetic Testing
Breast Cancer
Ovarian Cancer
Prostate Cancer
Pancreatic Cancer
Keywords: Educational Materials
Genetic Testing
Hereditary Cancer
Diverse Cancer Patients
20-458
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2021-02-12
Enrollment: 625
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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 participant has a genetic disorder, which is a disease caused in whole or in part by changes to the genes. Genetic testing can also help determine a person's chance of getting or passing on a genetic disorder. Genetic tests use a sample of blood, hair, skin, or other tissue, and they can look at one gene or multiple genes at the same time. Genetic testing may change the options for treating people with certain types of cancer. For example, some medications are more helpful for the treatment of cancer in people with certain gene changes (mutations).

The researchers are doing this study to develop new educational materials about genetic testing for people who speak different languages and have diverse cultural and educational backgrounds. During the study, the staff will interview participants with diverse cultural and educational backgrounds and ask them to review a sample of the educational materials that have been developed so far. Participants will give their opinions on these materials, and the researchers will use participants' feedback to improve the materials.

Detailed description: The objective of this proposal is to develop, test and evaluate a linguistically and culturally appropriate mainstreaming (LCAM) model for hereditary cancer multigene panel testing (MGPT) among cancer patients diverse in race/ethnicity, language, and education. The central hypothesis is that this LCAM genetic testing model will lead to better patient decision-making, psychosocial, and behavioral outcomes than a traditional model of genetic services represented by our standard-of-care arm. Breast, ovarian, pancreatic, and prostate cancer patients diverse in race/ethnicity, language (English, Haitian, Creole, and Spanish), and education will be recruited from partnering New York City community hospitals including Kings County Hospital and Queens Cancer Center. In Phase 1, the researchers will first conduct formative research including transcreation and cognitive interviewing to adapt our existing educational materials (brochure and video) and clinical communication materials (clinic visit summary and family dissemination messaging) for the LCAM model to be linguistically tailored to English, Haitian Creole, and Spanish-speaking patients, culturally sensitive to perspectives of Black and Latino patients, and inclusive of needs of patients with lower educational attainment. In Phase 2, the researchers will conduct a randomized clinical trial (RCT) to test and evaluate effects of the LCAM model for hereditary cancer MGPT as compared to standard-of-care among the diverse patients treated at the KCHC and QCC community hospitals. Patients diagnosed with breast, colorectal, ovarian, pancreatic, or prostate cancer. Patients will be offered hereditary cancer MGPT through either: i) standard-of-care wherein in-depth pre-test and post-test genetic counseling are provided via telegenetics (videoconferencing), or ii) LCAM intervention wherein patients receive adapted pretest educational materials from study staff and/or clinical staff and have testing ordered by their oncologist, followed by post-test genetic counseling via telephone with a health and genetic "literacy screener" and adapted clinical communication materials. Participants will be followed prospectively and will complete assessments consisting of validated and investigator-designed measures.

Primary outcomes include genetic test decision satisfaction and genetic counseling satisfaction and genetic counseling- satisfaction. Secondary outcomes include additional decision-making, psychosocial, and behavioral outcomes. The information in the ClinicalTrials.gov reflects the Phase 1 work only. The protocol and ClinicalTrials.gov record will be updated to reflect the Phase 2 work when this phase is ready to commence.

Phase 2: Participants will be recruited from our partnering sites, which include KCHC, QCC, JHMC, and the MSK RLCCC. Study staff will identify eligible patients from review of clinic lists and patient medical records, andrecords and will also receive direct study referrals from clinicians located at the partnering sites. Study staff will approach eligible patients in person or by telephone/text//email/snail mail (up to 5 attempts to make initial contact; up to 5 reminders to those who show initial interest) in order to describe the study, screen them for eligibility (including assessing language proficiency via self-report and prior experience with cancer genetic counseling/testing), and obtain informed consent and collect their contact information.

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".

Primary outcomes:
measure: Number of patients who complete the cognitive interview
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Kings County Hopsital Center
state: New York
city: Jamaica
country: United States
facility: Queens Cancer Center of Queens Hospital
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering at Ralph Lauren Center (Limited Protocol Activities)
state: New York
city: Richmond Hill
country: United States
facility: Jamaica Hospital Medical Center (Data Collection Only)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Jada Hamilton, PhD, MPH
role: PRINCIPAL_INVESTIGATOR
References: