Uusia koulutusmateriaaleja geneettisestä testauksesta erilaisille syöpäpotilaiden ryhmille (IMAGINE)
IMAGINE: Geneettisen tiedon saatavuuden parantaminen kaikille – Kielellisesti ja kulttuurisesti sopivan valtavirtaistamismallin kokeilu perinnöllisen syövän monigeenipaneelitestaukseen erilaisten syöpäpotilaiden keskuudessa
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Jennifer Hay, PhD
- Puhelinnumero: 646-888-0039
Tutki yhteystietojen varmuuskopiointi
- Nimi: Jada Hamilton, PhD, MPH
- Puhelinnumero: 646-888-0049
- Sähköposti: hamiltoj@mskcc.org
Opiskelupaikat
-
-
New York
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Brooklyn, New York, Yhdysvallat, 11203
- Rekrytointi
- Kings County Hopsital Center
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Ottaa yhteyttä:
- Jason Gonsky, MD
- Puhelinnumero: (718) 245-2847
-
Jamaica, New York, Yhdysvallat, 11432
- Rekrytointi
- Queens Cancer Center of Queens Hospital
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Ottaa yhteyttä:
- Linda Bulone, RN, OCN, CCRC
- Puhelinnumero: (718) 883-2958
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New York, New York, Yhdysvallat, 10035
- Rekrytointi
- Memorial Sloan Kettering at Ralph Lauren Center (Limited Protocol Activities)
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Ottaa yhteyttä:
- Jada Hamilton, PhD, MPH
- Puhelinnumero: 646-888-0049
-
Richmond Hill, New York, Yhdysvallat, 11418
- Rekrytointi
- Jamaica Hospital Medical Center (Data Collection Only)
-
Ottaa yhteyttä:
- Rosa Nouvini, MD
- Puhelinnumero: (718) 206-6000
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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".
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Terveyspalvelututkimus
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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. |
|
Active Comparator: 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 |
|
Active Comparator: 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. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Number of patients who complete the cognitive interview (Phase I)
Aikaikkuna: 1 year
|
the number of patients who complete the cognitive interview |
1 year
|
|
Genetic test decision (Phase II) satisfaction
Aikaikkuna: 6 months
|
is measured with the validated Satisfaction with Decisions scale. |
6 months
|
|
Genetic counseling satisfaction (Phase II)
Aikaikkuna: 6 months
|
is measured with the validated Genetic Counseling Satisfaction scale |
6 months
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Test uptake (Phase II)
Aikaikkuna: 6 months
|
the number of patients who complete multigene panel testing |
6 months
|
|
Knowledge (Phase II)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 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)
Aikaikkuna: 6 months
|
measured with investigator-designed items |
6 months
|
|
Family cascade testing (Phase II)
Aikaikkuna: 6 months
|
the number of first-degree relatives who complete genetic testing |
6 months
|
|
Intentions to adopt risk management behaviors (Phase II)
Aikaikkuna: 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)
Aikaikkuna: 6 months
|
measured with investigator-designed items |
6 months
|
Yhteistyökumppanit ja tutkijat
Tutkijat
- Päätutkija: Jada Hamilton, PhD, MPH, Memorial Sloan Kettering Cancer Center
Julkaisuja ja hyödyllisiä linkkejä
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Urogenitaaliset sairaudet
- Sukuelinten sairaudet
- Endokriinisen järjestelmän sairaudet
- Sukuelinten kasvaimet, mies
- Urogenitaaliset kasvaimet
- Neoplasmat sivustoittain
- Neoplasmat
- Sukuelinten sairaudet, mies
- Eturauhasen sairaudet
- Miesten urogenitaaliset sairaudet
- Naisten virtsa- ja sukupuolielinten sairaudet
- Naisten virtsa- ja sukupuolielinten sairaudet ja raskauden komplikaatiot
- Suoliston sairaudet
- Ruoansulatuskanavan kasvaimet
- Ruoansulatuskanavan kasvaimet
- Ruoansulatuskanavan sairaudet
- Ruoansulatuskanavan sairaudet
- Suoliston kasvaimet
- Peräsuolen sairaudet
- Sukuelinten sairaudet, naiset
- Endokriinisten rauhasten kasvaimet
- Haiman sairaudet
- Paksusuolen sairaudet
- Munasarjan sairaudet
- Adnexaaliset sairaudet
- Sukuelinten kasvaimet, naiset
- Sukurauhasten häiriöt
- Ihosairaudet
- Rintojen sairaudet
- Iho- ja sidekudostaudit
- Eturauhasen kasvaimet
- Kolorektaaliset kasvaimet
- Munasarjan kasvaimet
- Rintojen kasvaimet
- Haiman kasvaimet
- Terveyspalveluiden hallinto
- Terveydenhuollon laatu, saatavuus ja arviointi
- Terveydenhuollon laatu
- Laatuindikaattorit, terveydenhuolto
- Hoidon taso
Muut tutkimustunnusnumerot
- 20-458
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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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