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Ontwikkeling van nieuw educatief materiaal over genetische tests voor een diverse groep kankerpatiënten (IMAGINE)

1 oktober 2026 bijgewerkt door: Memorial Sloan Kettering Cancer Center

STEL JE VOOR: Verbetering van de toegang tot genetische informatie voor iedereen - een prospectieve proef van een taalkundig en cultureel passend mainstreammodel voor erfelijke kanker Multigene paneltesten onder diverse kankerpatiënten

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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 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. 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 useful for patients of many different backgrounds. 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 patients treated at local community hospitals. Patients diagnosed with breast, colorectal, ovarian, pancreatic, or prostate cancer 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 telegenetics 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. Phase 2 primary outcomes include genetic test decision satisfaction and genetic counseling satisfaction. Secondary outcomes include additional decision-making, psychosocial, and behavioral outcomes.

For Phase 2, participants will be recruited from our partnering sites, which include Kings County Hospital Center, Queens Cancer Center, Jamaica Hospital Medical Center, and the MSK Ralph Lauren Center for Cancer Care as well via referrals from underserved community sites through the MSK RLCCC network. Study staff will identify eligible patients from review of clinic lists and patient medical records, and will also receive direct study referrals from clinicians located at the partnering sites. Study staff will approach eligible patients 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.

Studietype

Ingrijpend

Inschrijving (Geschat)

445

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Jennifer Hay, PhD
  • Telefoonnummer: 646-888-0039

Studie Contact Back-up

Studie Locaties

  • Verenigde Staten
    • New York
      • Brooklyn, New York, Verenigde Staten, 11203
        • Werving
        • Kings County Hopsital Center
        • Contact:
          • Jason Gonsky, MD
          • Telefoonnummer: (718) 245-2847
      • Jamaica, New York, Verenigde Staten, 11432
        • Werving
        • Queens Cancer Center of Queens Hospital
        • Contact:
          • Linda Bulone, RN, OCN, CCRC
          • Telefoonnummer: (718) 883-2958
      • New York, New York, Verenigde Staten, 10035
        • Werving
        • Memorial Sloan Kettering at Ralph Lauren Center (Limited Protocol Activities)
        • Contact:
          • Jada Hamilton, PhD, MPH
          • Telefoonnummer: 646-888-0049
      • Richmond Hill, New York, Verenigde Staten, 11418
        • Werving
        • Jamaica Hospital Medical Center (Data Collection Only)
        • Contact:
          • Rosa Nouvini, MD
          • Telefoonnummer: (718) 206-6000

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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".

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Cognitive interview intervention for Phase 1

There is no treatment or intervention for Phase 1 of this study. Participants will be asked to participate in a cognitive interview.

This section will be amended to include the Phase 2 intervention information once the Phase 1 portion of the study is complete. The Phase 1 materials developed, and results obtained, will directly be part of and inform the intervention for Phase 2.Phase 2: participants will be randomized to the standard-of-care arm or the LCAM intervention arm.
Ander: Cognitive interview

Researchers will use formative methods to adapt our previously-developed mainstreaming pre-genetic test educational materials plus standard post-test clinical communication materials used by the MSK CGS for use with the diverse patients. Specifically, it will adapt these materials to be responsive to patients' linguistic and literacy needs, and sensitive to their cultural diversity.
Actieve vergelijker: Standard of care (Phase II only randomization)

Participants will receive in-depth pre-test and post-test genetic counseling provided via telegenetics
Gedragsmatig: Standard of care

Participants will receive in-depth pre-test and post-test genetic counseling provided via telegenetics
Actieve vergelijker: LCAM Intervention (Phase II only randomization)

Participants will 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 telegenetics with a health and genetic "literacy screener" and adapted clinical communication materials.
Gedragsmatig: LCAM intervention

Participants will 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 telegenetics with a health and genetic "literacy screener" and adapted clinical communication materials.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number of patients who complete the cognitive interview (Phase I)
Tijdsspanne: 1 year

the number of patients who complete the cognitive interview
1 year
Genetic test decision (Phase II) satisfaction
Tijdsspanne: 6 months

is measured with the validated Satisfaction with Decisions scale.
6 months
Genetic counseling satisfaction (Phase II)
Tijdsspanne: 6 months

is measured with the validated Genetic Counseling Satisfaction scale
6 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Test uptake (Phase II)
Tijdsspanne: 6 months

the number of patients who complete multigene panel testing
6 months
Knowledge (Phase II)
Tijdsspanne: 6 months

measured with items from the validated KnowGene scale (scores range from 0 to 6, higher scores indicate greater knowledge)
6 months
Empowerment (Phase II)
Tijdsspanne: 6 months

measured with the validated Genomics Outcome Scale (scores range from 6 to 30, higher scores indicate greater empowerment)
6 months
Distress (Phase II)
Tijdsspanne: 6 months

measured with the validated Hospital Anxiety and Depression Scale (total scale scores range from 0 to 42, higher scores indicate greater distress)
6 months
Concerns about genetic testing (Phase II)
Tijdsspanne: 6 months

measured with the validated Multidimensional Impact of Cancer Risk Assessment questionnaire (total scale scores range from 0 to 95, higher scores indicate greater concerns about genetic testing)
6 months
Family communication (Phase II)
Tijdsspanne: 6 months

measured with investigator-designed items
6 months
Family cascade testing (Phase II)
Tijdsspanne: 6 months

the number of first-degree relatives who complete genetic testing
6 months
Intentions to adopt risk management behaviors (Phase II)
Tijdsspanne: 6 months

measured with items derived from the Behavioral Risk Factor Surveillance System and National Health Interview Survey
6 months
Long term engagement and understanding (Phase II)
Tijdsspanne: 6 months

measured with investigator-designed items
6 months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Memorial Sloan Kettering Cancer Center

Onderzoekers

  • Hoofdonderzoeker: Jada Hamilton, PhD, MPH, Memorial Sloan Kettering Cancer Center

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

16 november 2021

Primaire voltooiing (Geschat)

31 augustus 2027

Studie voltooiing (Geschat)

31 augustus 2027

Studieregistratiedata

Eerst ingediend

8 februari 2021

Eerst ingediend dat voldeed aan de QC-criteria

8 februari 2021

Eerst geplaatst (Werkelijk)

12 februari 2021

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 oktober 2026

Laatste update ingediend die voldeed aan QC-criteria

1 oktober 2026

Laatst geverifieerd

1 oktober 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 20-458

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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