Psychotherapy Intervention for Latinos With Advanced Cancer

Official title

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

Overview

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 four phases. In the first two phases 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 155 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 Intergrated 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 third phase (Key Informant feedback), mental health providers will be interviewed to explore additional needed adaptations. The fourth phase will consist of pre-piloting or interviewing patients to assess the comprehension and acceptability of the adapted intervention.

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.

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 ot 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]

Secondary outcome measures (3)

• Depression and Anxiety measured with the Hospital Anxiety and Depression Scale [Time frame: Change from baseline to post assessment 7-14 weeks after]
• Hopelessness measured with the Beck Hopelessness Scale [Time frame: Change from baseline to post assessment 7-14 weeks after]
• Quality of life measured with the FACIT Spiritual Well-Being Scale [Time frame: Change from baseline to post assessment 7-14 weeks after]

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 package
• 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

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 3 centers

• Memorial Sloan Kettering Cancer Center — New York
• Ralph Lauren Center for Cancer Care and Prevention — New York
• Lincoln Medical and Mental Health Center — The Bronx

Puerto Rico · 1 center

• Ponce Health Sciences University — Ponce

Identifiers

NCT: NCT04015609 · 15-076

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗