Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04537936
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2020-09-01
Brief Title:
Psychotherapy Intervention for Latinos With Adv Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Adaptation and Pilot Feasibility of a Psychotherapy Intervention for Latinos With Advanced Cancer
Status:
RECRUITING
Status Verified Date:
2024-03
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:
None
Brief Summary:
The purpose of this study is to adapt a counseling intervention called Meaning Centered Psychotherapy to make it culturally relevant for Latinos Cancer affects patients and their loved ones Latinos often experience greater challenges due to the cancer However few studies and interventions focus on Latinos We are interested in understanding what affects Latino patients quality of life and how to improve it
Detailed Description:
Overview of the Study This project has 5 phases In phases 1 and 2 the study team will work to gain an understanding of the sources of meaning hope legacy and identity in Latino patients with advanced cancer and to explore the acceptability and feasibility of applying IMCP to Latinos diagnosed with advanced cancer A convergent mixed-methods design will be utilized with a sample of 200 Latino patients diagnosed with advanced cancer for the quantitative phase and a nested cohort of 14-20 for the qualitative phase from two cancer centers in New York City Memorial Sloan Kettering Cancer Center MSKCC and Lincoln Medical and Mental Health Center LMC a public hospital localized in a Latino-dense region We will also recruit eligible cancer patients serviced through Dr Ganys Integrated Cancer Care Access Network ICCAN The Integrated Cancer Care Access Network ICCAN of MSKCCs Immigrant Health and Cancer Disparities Service IHCD enrolls patients at eleven hospital-based cancer clinics in New York City with large numbers of immigrant and low-income patients ICCAN uses bilingual Access Facilitators to assist patients in accessing and utilizing health social and financial services Identified needs of the patients range from psychosocial support to health literacy child care financial housing and legal concerns Patients enrolled to the ICCAN program are actively obtaining support from Access Facilitators throughout their treatment period Access Facilitator will refer eligible patients to the study team for recruitment
Before moving to phase 3 we will adapt and transcreate the source text is rewritten to convey the concepts and achieve the aims of the source text while accounting for both language and cultural considerations the manual based on the phase 1 and 2 findings In the phase 3 Key Informant feedback mental health providers will be interviewed to explore additional needed adaptations
Phase 4 will consist of pre-piloting or interviewing patients to assess the comprehension and acceptability of the adapted intervention Patient Feedback phase key components of the intervention will be pre-piloted with 6-10 patients across MSKCC and Lincoln Medical and Mental Health Center LMC
Participants who express concerns or request assistance related to COVID-19 will be referred to publicly available resources as needed eg call 311 for access to health care or food panties etc and will be noted in internal tracking logs
Phase 5 Randomized Controlled Pilot Study Phase will collect preliminary data on the feasibility of recruitment retention and adherence and acceptability of content of Meaning-Centered Psychotherapy for Latinos MCP-L and key outcomes spiritual well-being depression anxiety hopelessness and quality of life Additional information will be collected specifically scales measuring attitudinal familism acculturation fatalism religiosity and literacy which will inform the design of a future large-scale randomized clinical trial of the culturally adapted intervention A sample of 60 Spanish-speaking advanced cancer patients will be enrolled and randomized evenly to MCP-L or to Enhanced Usual Care EUC control
Eligible patients for Phase 5 will meet the same criteria as Phase 1 patients however patients who score 4 on the Distress Thermometer will be recruited to Phase 5 and patients who score 4 will be recruited to Phase 1
Before moving to phase 3 we will adapt and transcreate the source text is rewritten to convey the concepts and achieve the aims of the source text while accounting for both language and cultural considerations the manual based on the phase 1 and 2 findings In the phase 3 Key Informant feedback mental health providers will be interviewed to explore additional needed adaptations
Phase 4 will consist of pre-piloting or interviewing patients to assess the comprehension and acceptability of the adapted intervention Patient Feedback phase key components of the intervention will be pre-piloted with 6-10 patients across MSKCC and Lincoln Medical and Mental Health Center LMC
Participants who express concerns or request assistance related to COVID-19 will be referred to publicly available resources as needed eg call 311 for access to health care or food panties etc and will be noted in internal tracking logs
Phase 5 Randomized Controlled Pilot Study Phase will collect preliminary data on the feasibility of recruitment retention and adherence and acceptability of content of Meaning-Centered Psychotherapy for Latinos MCP-L and key outcomes spiritual well-being depression anxiety hopelessness and quality of life Additional information will be collected specifically scales measuring attitudinal familism acculturation fatalism religiosity and literacy which will inform the design of a future large-scale randomized clinical trial of the culturally adapted intervention A sample of 60 Spanish-speaking advanced cancer patients will be enrolled and randomized evenly to MCP-L or to Enhanced Usual Care EUC control
Eligible patients for Phase 5 will meet the same criteria as Phase 1 patients however patients who score 4 on the Distress Thermometer will be recruited to Phase 5 and patients who score 4 will be recruited to Phase 1
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