Psychotherapy Intervention for Latinos With Adv Cancer
Adaptation and Pilot Feasibility of a Psychotherapy Intervention for Latinos With Advanced Cancer
1 other identifier
interventional
285
2 countries
4
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
Longer than P75 for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
September 1, 2020
CompletedFirst Posted
Study publicly available on registry
September 3, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2026
October 9, 2025
October 1, 2025
7.7 years
September 1, 2020
October 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Spiritual Well-Being measured with the FACIT Spiritual Well-Being Scale
FACIT Spiritual Well-Being Scale is a brief self-report measure designed to assess the nature and extent of individual spiritual well-being. This measure, which generates two sub-scales, one corresponding to Faith (the importance of faith and spirituality) and a second assessing Meaning-Peace (one sense of meaning and purpose in life), has been demonstrated to have strong internal reliability for both the total score as well as each subscale (coefficient alpha equals .87 for the total scale, .88 for the faith factor and .81 for the meaning factor). In additional, strong support for the external validity of this measure has been demonstrated in a several large samples of cancer and AIDS patients and with Spanish speaking populations.
Change from baseline to post assessment 7-14 weeks after
Secondary Outcomes (3)
Depression and Anxiety measured with the Hospital Anxiety and Depression Scale
Change from baseline to post assessment 7-14 weeks after
Hopelessness measured with the Beck Hopelessness Scale
Change from baseline to post assessment 7-14 weeks after
Quality of life measured with the FACIT Spiritual Well-Being Scale
Change from baseline to post assessment 7-14 weeks after
Study Arms (2)
Meaning Centered Psychotherapy for Latinos (MCP-L)
EXPERIMENTALControl
ACTIVE COMPARATORInterventions
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.
Determines the degree of spiritual well-being
Waitlist Control Patients in the control condition will be allocated to a waitlist group to receive the intervention approximately three months after randomization.
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.
Eligibility Criteria
You may qualify if:
- 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
- +14 more criteria
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
MSK at Ralph Lauren
New York, New York, 10035, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Lincoln Medical and Mental Health Center
The Bronx, New York, 10451, United States
Ponce Health Sciences University
Ponce, 00732, Puerto Rico
Related Links
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Rosario Costas-Muniz, PhD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
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
September 1, 2020
First Posted
September 3, 2020
Study Start
January 1, 2019
Primary Completion (Estimated)
August 31, 2026
Study Completion (Estimated)
August 31, 2026
Last Updated
October 9, 2025
Record last verified: 2025-10
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.