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Opracowanie nowych materiałów edukacyjnych na temat badań genetycznych dla zróżnicowanej grupy pacjentów z rakiem (IMAGINE)

1 października 2026 zaktualizowane przez: Memorial Sloan Kettering Cancer Center

IMAGINE: Poprawa dostępu do informacji genetycznych dla każdego – prospektywna próba odpowiedniego pod względem językowym i kulturowym modelu mainstreamingu dla wielogenowych testów panelowych raka dziedzicznego wśród różnych pacjentów z rakiem

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

445

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Jennifer Hay, PhD
  • Numer telefonu: 646-888-0039

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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".

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Inny: 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.
Aktywny komparator: Standard of care (Phase II only randomization)

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

Participants will receive in-depth pre-test and post-test genetic counseling provided via telegenetics
Aktywny komparator: 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.
Behawioralne: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Number of patients who complete the cognitive interview (Phase I)
Ramy czasowe: 1 year

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

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

is measured with the validated Genetic Counseling Satisfaction scale
6 months

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Test uptake (Phase II)
Ramy czasowe: 6 months

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

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

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

measured with investigator-designed items
6 months

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Memorial Sloan Kettering Cancer Center

Śledczy

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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Przydatne linki

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

16 listopada 2021

Zakończenie podstawowe (Szacowany)

31 sierpnia 2027

Ukończenie studiów (Szacowany)

31 sierpnia 2027

Daty rejestracji na studia

Pierwszy przesłany

8 lutego 2021

Pierwszy przesłany, który spełnia kryteria kontroli jakości

8 lutego 2021

Pierwszy wysłany (Rzeczywisty)

12 lutego 2021

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

5 października 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

1 października 2026

Ostatnia weryfikacja

1 października 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 20-458

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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