Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04751435
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2021-02-08
Brief Title:
Developing New Educational Materials About Genetic Testing for a Diverse Group of Cancer Patients
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IMAGINE
Brief Summary:
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 persons 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
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
Detailed Description:
The objective of this proposal is to develop test and evaluate a linguistically and culturally appropriate mainstreaming LCAM model for hereditary cancer multigene panel testing MGPT among cancer patients diverse in raceethnicity language and education 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 Breast ovarian pancreatic and prostate cancer patients diverse in raceethnicity language English Haitian Creole and Spanish and education will be recruited from partnering New York City community hospitals including Kings County Hospital and Queens Cancer Center 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 linguistically tailored to English Haitian Creole and Spanish-speaking patients culturally sensitive to perspectives of Black and Latino patients and inclusive of needs of patients with lower educational attainment 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 diverse patients treated at the KCHC and QCC community hospitals Patients diagnosed with breast colorectal ovarian pancreatic or prostate cancer Patients 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 and have testing ordered by their oncologist followed by post-test genetic counseling via telephone 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
Primary outcomes include genetic test decision satisfaction and genetic counseling satisfaction and genetic counseling- satisfaction Secondary outcomes include additional decision-making psychosocial and behavioral outcomes The information in the ClinicalTrialsgov reflects the Phase 1 work only The protocol and ClinicalTrialsgov record will be updated to reflect the Phase 2 work when this phase is ready to commence
Phase 2 Participants will be recruited from our partnering sites which include KCHC QCC JHMC and the MSK RLCCC Study staff will identify eligible patients from review of clinic lists and patient medical records andrecords and will also receive direct study referrals from clinicians located at the partnering sites Study staff will approach eligible patients in person or by telephonetextemailsnail mail up to 5 attempts to make initial contact up to 5 reminders to those who show initial interest in order to describe the study screen them for eligibility including assessing language proficiency via self-report and prior experience with cancer genetic counselingtesting and obtain informed consent and collect their contact information
Primary outcomes include genetic test decision satisfaction and genetic counseling satisfaction and genetic counseling- satisfaction Secondary outcomes include additional decision-making psychosocial and behavioral outcomes The information in the ClinicalTrialsgov reflects the Phase 1 work only The protocol and ClinicalTrialsgov record will be updated to reflect the Phase 2 work when this phase is ready to commence
Phase 2 Participants will be recruited from our partnering sites which include KCHC QCC JHMC and the MSK RLCCC Study staff will identify eligible patients from review of clinic lists and patient medical records andrecords and will also receive direct study referrals from clinicians located at the partnering sites Study staff will approach eligible patients in person or by telephonetextemailsnail mail up to 5 attempts to make initial contact up to 5 reminders to those who show initial interest in order to describe the study screen them for eligibility including assessing language proficiency via self-report and prior experience with cancer genetic counselingtesting and obtain informed consent and collect their contact information
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None