Recruiting

Psychotherapy

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT04537936

Conditions

Solid Tumor

Solid Tumor, Adult

Solid Tumor, Unspecified, Adult

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Meaning Centered Psychotherapy for Latinos

Functional Assessment of Cancer Therapy - Spiritual Well-Being Scale

Meaning Centered Psychotherapy for Latinos for Waitlist Control Patients

Pre-assessment questionnaire

Study Details

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

Conditions

Solid Tumor

Solid Tumor, Adult

Solid Tumor, Unspecified, Adult

Study ID

NCT04537936

Start date

Jan 1, 2019

Status verified date

Sep, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: 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
  • 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

Phase 5: Pilot RCT

  • Diagnosed with stages III or IV solid tumor cancer
  • Age 18 or older
  • Latino/a or Hispanic ethnicity
  • Fluent in oral Spanish (monolingual or bilingual)
  • Scores above the threshold for the Distress Thermometer (DT≥4)
  • 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.

Phase 5: Pilot RCT

  • Diagnosed with a major disabling medical
  • Diagnosed with a major disabling 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

Study Design

Enrollment

117 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Meaning Centered Psychotherapy for Latinos (MCP-L)

active comparator: Control

Interventions

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 of 7-14 weeks.

Functional Assessment of Cancer Therapy - Spiritual Well-Being Scale

Determines the degree of spiritual well-being

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.

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.

Primary outcome measure

  • Spiritual Well-Being measured with the FACIT Spiritual Well-Being Scale [ Time Frame: Change from baseline to post assessment 7-14 weeks after ]

Central Contacts and Locations

Central contacts

Devika Jutagar, PhD

646-888-8361jutagird@mskcc.org

William Breitbart, MD

646-888-0020breitbaw@mskcc.org

Locations

MSK at Ralph Lauren

Recruiting

New York, New York, United States, 10035

Contacts

Rosario Costas Muniz, PhD

646-888-8062

Memorial Sloan Kettering Cancer Center

Recruiting

New York, New York, United States, 10065

Contacts

Devika Jutagir, PhD

646-888-8361

Lincoln Medical and Mental Health Center

Recruiting

The Bronx, New York, United States, 10451

Contacts

Monica R Muppidi, MD

718-579-4900

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • Stage III solid tumor cancer
  • Stage IV solid tumor cancer
  • Stage III cancer
  • Stage IV cancer
  • Spanish
  • Memorial Sloan Kettering Cancer Center
  • 15-076

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-09-08.