A Study of Meaning-Centered Therapy for Mexican Adults With Advanced Cancer

Trial of Meaning Centered Psychotherapy for Mexican Patients With Advanced Cancer

The purpose of this study is to find out if Meaning-Centered Psychotherapy for Latinos (MCP-L) helps reduce anxiety and depression and improves quality of life compared to cognitive behavioral therapy (CBT). Investigators also want to learn what participants and providers think about the therapy, including how the therapy is designed, outside factors, available resources, and how the people involved affect how well MCP-L works.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Francesca Gany, MD, MS
  • Phone Number: 646-888-8054
  • Email: ganyf@mskcc.org

Study Contact Backup

Study Locations

      • Mexico City, Mexico
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Patient Eligibility Criteria:

A patient cannot be considered eligible for this study unless ALL of the following conditions are met. Participant eligibility will be determined by an initial EMR review followed by a self-report screener and suicide risk assessment.

Inclusion Criteria:

EMR Criteria

- Documentation of Disease

  • Pathologically confirmed breast, prostate, colorectal, thyroid, cervix, uteri, or lung - solid tumor cancer (either most recent or new diagnosis)

    • Definition of Disease [or Measurable Disease]
  • Diagnosed with stages III or IV

    • Prior Treatment
  • Receiving ambulatory care at INCan

Self-Report Criteria

  • Age ≥ 18 years
  • Able to read and communicate in Spanish determined by the question: "Can you read and communicate in Spanish? Yes/No"
  • Professional role of administrators, clinicians (e.g., oncologists), mental health providers, supervised therapists-in-training (e.g., graduate students), or other related provider delivering the MCP-L experimental intervention
  • Providing care (or services) to Mexican cancer patients at INCan
  • Has access to internet and an electronic device
  • Agrees to be audio-recorded

Exclusion Criteria:

EMR Criteria

  • Prior Treatment

    • Received psychological or psychiatric care at INCan in the last 3 months
    • In the judgment of the treating physician, protocol investigators, and/or study staff, presence of cognitive impairment (e.g., delirium or dementia) sufficient to preclude meaningful informed consent and/or study participation
    • Diagnosed with a serious psychiatric condition

Self-Report Criteria

  • Received psychological or psychiatric care outside of INCan in the last 3 months
  • Presence of suicide risk determined by the Columbia-Suicide Severity Rating Scale
  • Too ill to participate determined by the question: "Do you feel too ill to participate because of communication problems, uncontrollable pain, or other symptoms that prevent you from participating?"

Provider Eligibility Criteria:

Inclusion Criteria Self-Report Criteria

  • Age ≥ 18 years
  • Able to read and communicate in Spanish determined by the question: "Can you read and communicate in Spanish? Yes/No"
  • Professional role of administrators, clinicians (e.g., oncologists), mental health providers, supervised therapists-in-training (e.g., graduate students), or other related provider delivering the MCP-L experimental intervention
  • Providing care (or services) to Mexican cancer patients at INCan
  • Has access to internet and an electronic device
  • Agrees to be audio-recorded

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental Intervention
Meaning-Centered Psychotherapy for Latinos (MCP-L)
MCP-L is a structured 7-session manualized intervention culturally adapted into Spanish for Latino participants diagnosed with advanced cancer, which utilizes a mixture of didactics, discussion and experiential exercises that focus on particular themes related to meaning and advanced cancer. It is 60-minute individual sessions delivered every week or intermittently (depending on participant preference) for up to approximately 3 months (in this time period) in the event of medical illness.
No Intervention: Control Intervention
Cognitive Behavioral Therapy (CBT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in clinical levels of anxiety and depression for participants participating in Meaning-Centered Psychotherapy for Latinos (MCP-L)
Time Frame: 1 month
To examine the efficacy of Meaning-Centered Psychotherapy for Latinos (MCP-L) in improving clinical levels of anxiety and depression at 1-month post-intervention follow-up. Assessed using the General Anxiety Disorder 7-item scale (GAD-7; range 0-21, higher scores indicate greater anxiety levels) and the Patient Health Questionnaire 9-item scale (PHQ-9; range 0-27, higher scores indicate greater depression levels), respectively.
1 month
Change in clinical levels of anxiety and depression for participants participating in Meaning-Centered Psychotherapy for Latinos (MCP-L)
Time Frame: 3 months
To examine the efficacy of Meaning-Centered Psychotherapy for Latinos (MCP-L) in improving clinical levels of anxiety and depression at 3-month post-intervention follow-up. Assessed using the General Anxiety Disorder 7-item scale (GAD-7; range 0-21, higher scores indicate greater anxiety levels) and the Patient Health Questionnaire 9-item scale (PHQ-9; range 0-27, higher scores indicate greater depression levels), respectively.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Rosario Costas Muniz, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

April 13, 2029

Study Completion (Estimated)

April 13, 2029

Study Registration Dates

First Submitted

October 15, 2025

First Submitted That Met QC Criteria

November 4, 2025

First Posted (Actual)

November 6, 2025

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 3, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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