Psychotherapy Intervention for Latinos With Advanced Cancer
NCT ID: NCT04015609
Last Updated: 2025-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
190 participants
INTERVENTIONAL
2015-04-20
2026-08-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Meaning Centered Psychotherapy for Latinos (MCP-L)
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.
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.
Control
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.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Lincoln Medical and Mental Health Center
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Rosario Costas-Muniz, PhD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center
New York, New York, United States
Ralph Lauren Center for Cancer Care and Prevention
New York, New York, United States
Lincoln Medical and Mental Health Center
The Bronx, New York, United States
Ponce Health Sciences University
Ponce, , Puerto Rico
Countries
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Central Contacts
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Facility Contacts
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Rosario Costas-Muniz, PhD
Role: primary
Rosa Nouvini, MD
Role: primary
Caroline Hwang, MD
Role: primary
Related Links
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Related Info
Other Identifiers
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15-076
Identifier Type: -
Identifier Source: org_study_id
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