Solid TumorNCT04537936
Psychotherapy Intervention for Latinos With Adv Cancer
A study testing Meaning Centered Psychotherapy for Latinos, Functional Assessment of Cancer Therapy - Spiritual Well-Being Scale and Pre-assessment questionnaire in people with Solid Tumor and Solid Tumor, Adult, run by Memorial Sloan Kettering Cancer Center at 4 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Solid Tumor, Solid Tumor, Adult, Solid Tumor, Unspecified, Adult
- What is being tested?
- Meaning Centered Psychotherapy for Latinos, Functional Assessment of Cancer Therapy - Spiritual Well-Being Scale and Pre-assessment questionnaire
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 117 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Jan 2019to 31 Aug 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
MSK at Ralph Lauren
New York, New York, 10035
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Lincoln Medical and Mental Health Center
The Bronx, New York, 10451
About this study
Official title: Adaptation and Pilot Feasibility of a Psychotherapy Intervention for Latinos With Advanced Cancer
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
Read the detailed description
Overview of the Study. This project has 5 phases. In phases 1 and 2 the study team will work to gain an understanding of the sources of meaning, hope, legacy and identity in Latino patients with advanced cancer; and to explore the acceptability and feasibility of applying IMCP to Latinos diagnosed with advanced cancer. A convergent mixed-methods design will be utilized with a sample of 200 Latino patients diagnosed with advanced cancer for the quantitative phase, and a nested cohort of 14-20 for the qualitative phase from two cancer centers in New York City: Memorial Sloan Kettering Cancer Center (MSKCC) and Lincoln Medical and Mental Health Center (LMC), a public hospital localized in a Latino-dense region. We will also recruit eligible cancer patients serviced through Dr. Gany's Integrated Cancer Care Access Network (ICCAN). The Integrated Cancer Care Access Network (ICCAN) of MSKCC's Immigrant Health and Cancer Disparities Service (IHCD) enrolls patients at eleven hospital-based cancer clinics in New York City with large numbers of immigrant and low-income patients. ICCAN uses bilingual Access Facilitators to assist patients in accessing and utilizing health, social, and financial services. Identified needs of the patients, range from psychosocial support, to health literacy, child care, financial, housing and legal concerns. Patients enrolled to the ICCAN program are actively obtaining support from Access Facilitators throughout their treatment period. Access Facilitator will refer eligible patients to the study team for recruitment.
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 phase 3 (Key Informant feedback), mental health providers will be interviewed to explore additional needed adaptations.
Phase 4 will consist of pre-piloting or interviewing patients to assess the comprehension and acceptability of the adapted intervention. Patient Feedback phase, key components of the intervention will be pre-piloted with 6-10 patients across MSKCC and, Lincoln Medical and Mental Health Center (LMC)
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.
Phase 5 Randomized Controlled Pilot Study Phase will collect preliminary data on the feasibility of recruitment, retention and adherence and acceptability of content of Meaning-Centered Psychotherapy for Latinos (MCP-L) and key outcomes (spiritual well-being, depression, anxiety, hopelessness, and quality of life). Additional information will be collected, specifically scales measuring , attitudinal familism, acculturation, fatalism, religiosity, literacy , and racial microaggressions which will inform the design of a future large-scale randomized clinical trial of the culturally adapted intervention. A sample of 60 Spanish-speaking advanced cancer patients will be enrolled and randomized evenly to MCP-L or to Enhanced Usual Care (EUC) control.
Eligible patients for Phase 5 will meet the same criteria as Phase 1 patients ; however patients who score > 4 on the Distress Thermometer will be recruited to Phase 5, and patients who score < 4 will be recruited to Phase 1.
- Being tested
- Meaning Centered Psychotherapy for Latinos, Functional Assessment of Cancer Therapy - Spiritual Well-Being Scale, Meaning Centered Psychotherapy for Latinos for Waitlist Control Patients, Pre-assessment questionnaire
- Keywords
- Stage III solid tumor cancer, Stage IV solid tumor cancer, Stage III cancer, Stage IV cancer, Spanish, Memorial Sloan Kettering Cancer Center, 15-076
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meaning Centered Psychotherapy for LatinosBehavioural
Also called MCP-L
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.
Functional Assessment of Cancer Therapy - Spiritual Well-Being ScaleBehavioural
Determines the degree of spiritual well-being
Meaning Centered Psychotherapy for Latinos for Waitlist Control PatientsBehavioural
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 questionnaireBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Meaning Centered Psychotherapy for Latinos (MCP-L) | Experimental | Not described Receives: Behavioral: Meaning Centered Psychotherapy for Latinos; Behavioral: Functional Assessment of Cancer Therapy - Spiritual Well-Being Scale; Behavioral: Meaning Centered Psychotherapy for Latinos for Waitlist Control Patients; Behavioral: Pre-assessment questionnaire |
| Control | Active comparator | Not described Receives: Behavioral: Meaning Centered Psychotherapy for Latinos; Behavioral: Functional Assessment of Cancer Therapy - Spiritual Well-Being Scale; Behavioral: Meaning Centered Psychotherapy for Latinos for Waitlist Control Patients; Behavioral: Pre-assessment questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to post assessment 7-14 weeks after
Secondary outcomes (3)
Depression and Anxiety measured with the Hospital Anxiety and Depression Scale
The Hospital Anxiety and Depression Scale (HADS) is a validated scale used to measure anxiety and depression. This scale has been validated against structured or semi-structured clinical interviews, the gold standard for the assessment of mental disorders, in a significant number of studies. Further strengths of this scale for the assessment of emotional distress in cancer patients stem from the joint assessment of anxiety and depressive symptoms without referring to physical symptoms of anxiety or depression. Given the high comorbidity of anxiety of cancer as well as the systematic exclusion of confounding physical symptoms, the scale seems especially appropriate for use in this patient group. The HADS consists of 14 items which reflect a 7-item anxiety and a 7-item depression subscale. This scale has sound psychometric properties in Spanish.
Measured: Change from baseline to post assessment 7-14 weeks after
Hopelessness measured with the Beck Hopelessness Scale
The Beck Hopelessness Scale (BHS) comprises 20 true/false questions that assess degree of pessimism and hopelessness. Several studies have demonstrated a high degree of internal consistency and construct validity. Scores ranging from 4 to 8 typically indicate a "mild" degree of hopelessness, 9 to 12 correspond to "moderate" hopelessness, and scores about 12 reflect "severe" levels of hopelessness.
Measured: Change from baseline to post assessment 7-14 weeks after
Quality of life measured with the FACIT Spiritual Well-Being Scale
The FACIT Spiritual Well-Being Scale (FACIT-Sp-12) is a brief self-report measure designed to assess the nature and extent of individual's spiritual well-being. This measure (range 0-48), which generates two sub-scales, Faith (the importance of faith/spirituality, range 0-16) and Meaning /Peace (one's sense of meaning and purpose in life, range 0-32). The total score for the FACIT-Sp scale is the sum of the two subscales Faith and Meaning /Peace. It has been demonstrated to have strong internal reliability for both the total score as well as each subscale (coefficient alpha = .87 for the total scale, .88 for the faith factor and .81 for the meaning factor). Higher scores represent a higher level of spiritual well-being, faith or meaning-peace. In addition, 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. Administration time takes approximately 4 minutes.
Measured: Change from baseline to post assessment 7-14 weeks after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2020
- Study start1 Jan 2019
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Lincoln Medical and Mental Health Center
- Responsible party
- Sponsor
- Investigators
- Devika Jutagar, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04537936
- Sponsor's protocol ID
- 15-076A(20)
- Status last verified
- Oct 2026
- First submitted
- 1 Sep 2020
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.