Vývoj nových vzdělávacích materiálů o genetickém testování pro různé skupiny pacientů s rakovinou (IMAGINE)
IMAGINE: Zlepšování přístupu ke genetickým informacím pro každého – Prospektivní zkouška lingvisticky a kulturně vhodného modelu mainstreamingu pro dědičnou rakovinu Multigenní panelové testování mezi různými pacienty s rakovinou
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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 studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Jennifer Hay, PhD
- Telefonní číslo: 646-888-0039
Studijní záloha kontaktů
- Jméno: Jada Hamilton, PhD, MPH
- Telefonní číslo: 646-888-0049
- E-mail: hamiltoj@mskcc.org
Studijní místa
-
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New York
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Brooklyn, New York, Spojené státy, 11203
- Nábor
- Kings County Hopsital Center
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Kontakt:
- Jason Gonsky, MD
- Telefonní číslo: (718) 245-2847
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Jamaica, New York, Spojené státy, 11432
- Nábor
- Queens Cancer Center of Queens Hospital
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Kontakt:
- Linda Bulone, RN, OCN, CCRC
- Telefonní číslo: (718) 883-2958
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New York, New York, Spojené státy, 10035
- Nábor
- Memorial Sloan Kettering at Ralph Lauren Center (Limited Protocol Activities)
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Kontakt:
- Jada Hamilton, PhD, MPH
- Telefonní číslo: 646-888-0049
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Richmond Hill, New York, Spojené státy, 11418
- Nábor
- Jamaica Hospital Medical Center (Data Collection Only)
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Kontakt:
- Rosa Nouvini, MD
- Telefonní číslo: (718) 206-6000
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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:
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Age ≥ 18 years as per the medical record and/or clinician referral
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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:
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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)
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colorectal cancer
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Ovarian cancer criteria:
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invasive ovarian cancer
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Pancreatic cancer criteria:
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pancreatic adenocarcinoma
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Prostate cancer criteria:
- castrate-resistant, metastatic prostate cancer;
- high-risk prostate cancer (pending pathology definition)
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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
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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".
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Výzkum zdravotnických služeb
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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. |
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. |
|
Aktivní komparátor: Standard of care (Phase II only randomization)
Participants will receive in-depth pre-test and post-test genetic counseling provided via telegenetics |
Participants will receive in-depth pre-test and post-test genetic counseling provided via telegenetics |
|
Aktivní komparátor: 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. |
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 je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Number of patients who complete the cognitive interview (Phase I)
Časové okno: 1 year
|
the number of patients who complete the cognitive interview |
1 year
|
|
Genetic test decision (Phase II) satisfaction
Časové okno: 6 months
|
is measured with the validated Satisfaction with Decisions scale. |
6 months
|
|
Genetic counseling satisfaction (Phase II)
Časové okno: 6 months
|
is measured with the validated Genetic Counseling Satisfaction scale |
6 months
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Test uptake (Phase II)
Časové okno: 6 months
|
the number of patients who complete multigene panel testing |
6 months
|
|
Knowledge (Phase II)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 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)
Časové okno: 6 months
|
measured with investigator-designed items |
6 months
|
|
Family cascade testing (Phase II)
Časové okno: 6 months
|
the number of first-degree relatives who complete genetic testing |
6 months
|
|
Intentions to adopt risk management behaviors (Phase II)
Časové okno: 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)
Časové okno: 6 months
|
measured with investigator-designed items |
6 months
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Jada Hamilton, PhD, MPH, Memorial Sloan Kettering Cancer Center
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Onemocnění genitálií
- Onemocnění endokrinního systému
- Genitální novotvary, muži
- Urogenitální novotvary
- Novotvary podle místa
- Novotvary
- Onemocnění pohlavních orgánů, muž
- Onemocnění prostaty
- Mužská urogenitální onemocnění
- Ženské urogenitální onemocnění
- Ženské urogenitální onemocnění a těhotenské komplikace
- Střevní nemoci
- Gastrointestinální novotvary
- Novotvary trávicího systému
- Nemoci trávicího systému
- Gastrointestinální onemocnění
- Střevní novotvary
- Rektální onemocnění
- Onemocnění pohlavních orgánů, ženy
- Novotvary endokrinních žláz
- Onemocnění slinivky břišní
- Onemocnění tlustého střeva
- Onemocnění vaječníků
- Adnexální onemocnění
- Genitální novotvary, ženy
- Gonadální poruchy
- Kožní choroby
- Nemoci prsu
- Onemocnění kůže a pojivové tkáně
- Novotvary prostaty
- Kolorektální novotvary
- Novotvary vaječníků
- Novotvary prsu
- Novotvary pankreatu
- Správa zdravotnických služeb
- Kvalita zdravotní péče, přístup a hodnocení
- Kvalita zdravotní péče
- Ukazatele kvality, zdravotní péče
- Standard péče
Další identifikační čísla studie
- 20-458
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Popis plánu 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.
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