Clinical trial NCT04537936: Psychotherapy Intervention for Latinos With Adv Cancer
Official title: Adaptation and Pilot Feasibility of a Psychotherapy Intervention for Latinos With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Solid Tumor
Solid Tumor, Adult
Solid Tumor, Unspecified, Adult
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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: Lincoln Medical and Mental Health Center
First posted: 2020-09-03
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

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.

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

Primary outcomes:
measure: Spiritual Well-Being measured with the FACIT Spiritual Well-Being Scale
timeFrame: Change from baseline to post assessment 7-14 weeks after
Secondary outcomes:
measure: Depression and Anxiety measured with the Hospital Anxiety and Depression Scale
timeFrame: Change from baseline to post assessment 7-14 weeks after
measure: Hopelessness measured with the Beck Hopelessness Scale
timeFrame: Change from baseline to post assessment 7-14 weeks after
measure: Quality of life measured with the FACIT Spiritual Well-Being Scale
timeFrame: Change from baseline to post assessment 7-14 weeks after
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Lincoln Medical and Mental Health Center
state: New York
city: New York
country: United States
facility: MSK at Ralph Lauren
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Ponce
country: Puerto Rico
facility: Ponce Health Sciences University
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Rosario Costas-Muniz, PhD
role: PRINCIPAL_INVESTIGATOR
References: