NCT07225309

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
35mo left

Started Jun 2026

Typical duration for not_applicable breast-cancer

Geographic Reach
2 countries

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress1%
Jun 2026Apr 2029

First Submitted

Initial submission to the registry

October 15, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

November 6, 2025

Completed
7 months until next milestone

Study Start

First participant enrolled

June 1, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 13, 2029

Last Updated

June 4, 2026

Status Verified

June 1, 2026

Enrollment Period

2.9 years

First QC Date

October 15, 2025

Last Update Submit

June 3, 2026

Conditions

Keywords

Breast cancerBreast cancer Stage IIIBreast cancer Stage IVProstate cancerProstate cancer Stage IIIProstate cancer Stage IVColorectal cancerColorectal cancer Stage IIIColorectal cancer Stage IVThyroid cancerThyroid cancer Stage IIIThyroid cancer Stage IV25-240Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (2)

  • Change in clinical levels of anxiety and depression for participants participating in Meaning-Centered Psychotherapy for Latinos (MCP-L)

    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)

    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

Study Arms (2)

Experimental Intervention

EXPERIMENTAL

Meaning-Centered Psychotherapy for Latinos (MCP-L)

Behavioral: Meaning-Centered Psychotherapy for Latinos /MCP-L

Control Intervention

NO INTERVENTION

Cognitive Behavioral Therapy (CBT)

Interventions

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.

Experimental Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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:
  • 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
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Memorial Sloan Kettering Cancer Center

New York, New York, 10065, United States

Location

Instituto Nacional de Cancerología (INCan)

Mexico City, Mexico

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsProstatic NeoplasmsColorectal NeoplasmsThyroid Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesEndocrine Gland NeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Rosario Costas Muniz, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosario Costas Muniz, PhD

CONTACT

Francesca Gany, MD, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 15, 2025

First Posted

November 6, 2025

Study Start

June 1, 2026

Primary Completion (Estimated)

April 13, 2029

Study Completion (Estimated)

April 13, 2029

Last Updated

June 4, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

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.

Locations