NCT04537936 Psychotherapy Intervention for Latinos With Adv Cancer
| NCT ID | NCT04537936 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Memorial Sloan Kettering Cancer Center |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 285 participants |
| Start Date | 2019-01-01 |
| Primary Completion | 2026-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 285 participants in total. It began in 2019-01-01 with a primary completion date of 2026-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Rosario Costas-Muniz, PhD
PRINCIPAL INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Frequently Asked Questions
Who can join the NCT04537936 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04537936 currently recruiting?
Yes, NCT04537936 is actively recruiting participants. Contact the research team at costasmr@mskcc.org for enrollment information.
Where is the NCT04537936 trial being conducted?
This trial is being conducted at New York, United States, New York, United States, The Bronx, United States, Ponce, Puerto Rico.
Who is sponsoring the NCT04537936 clinical trial?
NCT04537936 is sponsored by Memorial Sloan Kettering Cancer Center. The principal investigator is Rosario Costas-Muniz, PhD at Memorial Sloan Kettering Cancer Center. The trial plans to enroll 285 participants.