NCT04537936 · Memorial Sloan Kettering Cancer Center
Psychotherapy Intervention for Latinos With Adv Cancer
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
BEHAVIORAL
Functional Assessment of Cancer Therapy - Spiritual Well-Being Scale
Determines the degree of spiritual well-being
BEHAVIORAL
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.
BEHAVIORAL
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 measures
Spiritual Well-Being measured with the FACIT Spiritual Well-Being Scale
Time frame: Change from baseline to post assessment 7-14 weeks after
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- New York, New York
- The Bronx, New York
Collaborators
Lincoln Medical and Mental Health Center
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 9, 2025 · Source of record for eligibility and locations