Culturally relevant psychotherapy for Latinos with advanced cancer

Adaptation and Pilot Feasibility of a Psychotherapy Intervention for Latinos With Advanced Cancer

This study is trying to see if a new type of therapy, specially designed for Latino patients with advanced cancer, can help them find meaning and hope during their treatment.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 285 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Memorial Sloan Kettering Cancer Center (other)
• Locations: 4 sites (New York, New York and 3 other locations)
• Trial ID: NCT04537936 on ClinicalTrials.gov

What this trial studies

This project aims to adapt Meaning Centered Psychotherapy to be culturally relevant for Latino patients diagnosed with advanced solid tumors. The study will involve five phases, starting with understanding the sources of meaning and hope for these patients, followed by assessing the acceptability and feasibility of the intervention. A mixed-methods design will be employed, including a quantitative phase with 200 participants and a qualitative phase with a smaller cohort. The study will take place at two cancer centers in New York City, focusing on Latino patients who often face unique challenges due to their cultural background.

Who should consider this trial

Good fit: Ideal candidates are Latino or Hispanic adults aged 18 or older with stages III or IV solid tumor cancer who are fluent in Spanish.

Not a fit: Patients who do not identify as Latino or Hispanic or those with earlier stages of cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this intervention could significantly improve the quality of life for Latino patients facing advanced cancer.

How similar studies have performed: While there is limited research specifically targeting Latino patients with advanced cancer, similar culturally adapted interventions have shown promise in improving patient outcomes in other populations.

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

Where this trial is running

New York, New York and 3 other locations

• MSK at Ralph Lauren — New York, New York, United States (RECRUITING)
• Memorial Sloan Kettering Cancer Center — New York, New York, United States (RECRUITING)
• Lincoln Medical and Mental Health Center — The Bronx, New York, United States (RECRUITING)
• Ponce Health Sciences University — Ponce, Puerto Rico (RECRUITING)

Study contacts

• Principal investigator: Rosario Costas-Muniz, PhD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Rosario Costas-Muniz, PhD

Conditions: Solid Tumor, Solid Tumor, Adult, Solid Tumor, Unspecified, Adult, Stage III solid tumor cancer, Stage IV solid tumor cancer, Stage III cancer, Stage IV cancer, Spanish