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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study will help improve materials that explain genetic testing, which looks for changes in genes. It is for adults with certain cancers who speak English, Haitian Creole, or Spanish and come from different backgrounds. Participants will take part in interviews and share their views on sample materials.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Both phases: You must be age 18 or older.
  • Phase 1: You have or have had breast, ovarian, pancreatic, or prostate cancer. People who identify as Black, Latino, or neither may join.
  • Phase 1: You must speak and read English, Haitian Creole, or Spanish well or very well.
  • Phase 2: You have or have had breast, colorectal, ovarian, pancreatic, or prostate cancer. Some cancer types have extra rules listed below.
  • Phase 2, breast cancer: You must meet at least one rule: diagnosed at 65 or younger; triple-negative cancer; more than one separate breast cancer; being considered for a PARP cancer drug; certain family histories of breast, ovarian, or pancreatic cancer; or approval based on your clinician’s judgment.
  • Phase 2, other cancer rules: Ovarian cancer must be invasive, meaning it has grown into nearby tissue. Pancreatic cancer must be a type called adenocarcinoma. Prostate cancer must be high-risk, or have spread and no longer respond to treatment that lowers male hormones.
  • Phase 2: You must speak English, Haitian Creole, or Spanish well or very well.
  • Phase 2: You must not have had cancer genetic counseling or testing for inherited gene changes linked to cancer risk.

Who can't join

  • Both phases: A clinician or the person seeking your consent decides that you cannot make informed decisions about joining.
  • Both phases: You report speaking the study language not well or not at all. Phase 1 also requires reading it well or very well.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 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".

Study sites (4)

NY