Psychotherapy Intervention for Latinos With Adv Cancer

Solid Tumor Clinical Trial

Official title: Adaptation and Pilot Feasibility of a Psychotherapy Intervention for Latinos With Advanced Cancer

Status Recruiting

Clinical Trial 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

Clinical Trial 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. Gany's Integrated Cancer Care Access Network (ICCAN). The Integrated Cancer Care Access Network (ICCAN) of MSKCC's 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 (e.g., 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. ;

Related Conditions & MeSH terms

• Neoplasms
• Solid Tumor
• Solid Tumor, Adult
• Solid Tumor, Unspecified, Adult

• NCT number: NCT04537936
• Study type: Interventional
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Rosario Costas-Muniz, PhD
• Phone: 646-888-8062
• Email: costasmr@mskcc.org
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2019
• Completion date: August 31, 2024