Psychotherapy Intervention for Latinos With Advanced Cancer

NCT ID: NCT04015609

Last Updated: 2025-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

190 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-20

Study Completion Date

2026-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Overview of the Study. This project has four phases. In the first two phases 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 155 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 Intergrated 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 third phase (Key Informant feedback), mental health providers will be interviewed to explore additional needed adaptations. The fourth phase will consist of pre-piloting or interviewing patients to assess the comprehension and acceptability of the adapted intervention.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Solid Tumor Solid Tumor, Adult Solid Tumor, Unspecified, Adult

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Meaning Centered Psychotherapy for Latinos (MCP-L)

Group Type EXPERIMENTAL

Meaning Centered Psychotherapy for Latinos

Intervention Type BEHAVIORAL

MCP-L consists of seven-60 minute-individual sessions. The seven sessions are expected to be delivered every week or every two weeks over a span ot 7-14 weeks.

Functional Assessment of Cancer Therapy - Spiritual Well-Being Scale

Intervention Type BEHAVIORAL

Determines the degree of spiritual well-being

Meaning Centered Psychotherapy for Latinos for Waitlist Control Patients

Intervention Type BEHAVIORAL

Waitlist Control Patients in the control condition will be allocated to a waitlist group to receive the intervention approximately three months after randomization.

Pre-assessment questionnaire

Intervention Type BEHAVIORAL

Which includes 10 standardized scales Assessment/Evaluation Plan, Phase 1, 4 - Quantitative Measure Questionnaire).The interview guide will inquire about the comprehension and acceptability of, and alternative options for, these intervention components.

Control

Group Type ACTIVE_COMPARATOR

Meaning Centered Psychotherapy for Latinos

Intervention Type BEHAVIORAL

MCP-L consists of seven-60 minute-individual sessions. The seven sessions are expected to be delivered every week or every two weeks over a span ot 7-14 weeks.

Functional Assessment of Cancer Therapy - Spiritual Well-Being Scale

Intervention Type BEHAVIORAL

Determines the degree of spiritual well-being

Meaning Centered Psychotherapy for Latinos for Waitlist Control Patients

Intervention Type BEHAVIORAL

Waitlist Control Patients in the control condition will be allocated to a waitlist group to receive the intervention approximately three months after randomization.

Pre-assessment questionnaire

Intervention Type BEHAVIORAL

Which includes 10 standardized scales Assessment/Evaluation Plan, Phase 1, 4 - Quantitative Measure Questionnaire).The interview guide will inquire about the comprehension and acceptability of, and alternative options for, these intervention components.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Meaning Centered Psychotherapy for Latinos

MCP-L consists of seven-60 minute-individual sessions. The seven sessions are expected to be delivered every week or every two weeks over a span ot 7-14 weeks.

Intervention Type BEHAVIORAL

Functional Assessment of Cancer Therapy - Spiritual Well-Being Scale

Determines the degree of spiritual well-being

Intervention Type BEHAVIORAL

Meaning Centered Psychotherapy for Latinos for Waitlist Control Patients

Waitlist Control Patients in the control condition will be allocated to a waitlist group to receive the intervention approximately three months after randomization.

Intervention Type BEHAVIORAL

Pre-assessment questionnaire

Which includes 10 standardized scales Assessment/Evaluation Plan, Phase 1, 4 - Quantitative Measure Questionnaire).The interview guide will inquire about the comprehension and acceptability of, and alternative options for, these intervention components.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

MCP-L

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Phase I: Quantitative

* Diagnosed with stages III or IV solid tumor cancer \*(as per self report for ICCAN patients)
* Age 18 or older
* As per self report, Latino/a or Hispanic ethnicity
* As per self report, fluent in oral Spanish (monolingual) or fluent in oral Spanish and English (bilingual)

Phase 2: Qualitative

* Enrolled in the quantitative phase of study (as seen above)
* Completes the quantitative phase questionnaire package
* Scores above or below the threshold for the Distress Thermometer (DT≥4 or ≤3)
* In the judgment of the investigator, willing and able to be interviewed in Spanish only
* Agrees to be audio- recorded

Phase 3: Provider Feedback

* Professionals working in the mental health field;
* Have a caseload of five or more Latino cancer patients per month
* Able to communicate and read in Spanish
* Agrees to be audio or video-recorded

Phase 4: Patient Feedback

* Diagnosed with stages III or IV solid tumor cancer \*(as per self report for ICCAN patients)
* Age 18 or older
* As per self report, Latino/a or Hispanic ethnicity
* In the judgment of the investigator, willing and able to be interviewed in Spanish only
* Agrees to be audio-recorded

Exclusion Criteria

Phase 1: Quantitative

* In the judgment of the treating physician and/or the consenting professional, presence of significant cognitive impairment (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection
* In the judgment of the consenting professional, significant or major disabling medical or psychiatric condition sufficient to preclude meaningful informed consent, interview, or completion of assessment measures (patients whose psychiatric disorder is well controlled by treatment will be eligible)

Phase 2: Qualitative

* In the judgment of the treating physician and/or the consenting professional, presence of significant cognitive impairment (i.e., delirium or dementia) sufficient to preclude meaningful informed consent and/or data collection
* In the judgment of the consenting professional, significant or major disabling medical or psychiatric condition sufficient to preclude meaningful informed consent, interview, or completion of assessment measures (patients whose psychiatric disorder is well controlled by treatment will be eligible)

Phase 4: Patient Feedback

* Diagnosed with a major disabling medical or psychiatric condition
* Unable to understand the consent procedure
* Too ill to participate, all as reported by the patient and/or determined by the investigator's judgment.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lincoln Medical and Mental Health Center

OTHER

Sponsor Role collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rosario Costas-Muniz, PhD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Site Status RECRUITING

Ralph Lauren Center for Cancer Care and Prevention

New York, New York, United States

Site Status RECRUITING

Lincoln Medical and Mental Health Center

The Bronx, New York, United States

Site Status RECRUITING

Ponce Health Sciences University

Ponce, , Puerto Rico

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Puerto Rico

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Rosario Costas-Muniz, PhD

Role: CONTACT

646-888-8062

William Breitbart, MD

Role: CONTACT

646-888-0020

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Rosario Costas-Muniz, PhD

Role: primary

646-888-8062

Rosa Nouvini, MD

Role: primary

646-608-0279

Caroline Hwang, MD

Role: primary

718-579-5000

Eida Castro-Figueroa, PhD

Role: primary

Related Links

Access external resources that provide additional context or updates about the study.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15-076

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.