CompletedNot applicableNCT03016403

A Stepped Care Intervention to Reduce Disparities in Mental Health Services Among Cancer Patients and Caregivers

Medically under-served (i.e., low-income, uninsured, underinsured) cancer patients generally encounter significant disparities in accessing care for their mental health needs while undergoing toxic treatments that provide considerable physical and emotional stress. Thus, the investigators propose to adapt evidence-based strategies to a stepped-care intervention model to address the mental health needs of under-served lung cancer (LC) and head and neck cancer (HNC) patients and their caregivers across several levels of symptom severity (e.g., mild, moderate, or severe symptoms of depression and anxiety).

Checked against the public recordLast updated Mar 19, 2021 · Source: ClinicalTrials.gov

StatusCompleted
PhaseNot applicable
U.S. locations5
SponsorUniversity of Colorado, Denver
01
Study overview

What this study is about

Purpose
Supportive Care
Study type
Interventional
Phase
Not applicable
Sponsor
University of Colorado, Denver
Interventions being studied
Behavioral: Stepped-Care Intervention; Behavioral: Enhanced Usual Care
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

03
Public criteria

Who may be able to participate

1. LC and HNC patients: Inclusion Criteria: * Newly diagnosed LC and/or HNC (within a month of recruitment date from the date of 1st visit oncology, Ear Nose and Throat (ENT), or radiation clinic visit/consultation upon pathologic tissue diagnosis; * LC and/or HNC patients at any stage of diagnosis (Stages 0-IV); * Over 18 years old; * English and/or Spanish speaking; * Medically underserved, as defined by at least one or several of the following: 1. Low-income: Below 400% of the 2016 Federal poverty levels; 2. Uninsured: No health insurance (public or private insurance); 3. Underinsured: e.g.: Public insurance (Medicaid, Medicare exclusive, VA); and/or 10% of annual income on out-of-pocket medical expenses for individuals below 200% of the 2016 Federal poverty levels. Exclusion Criteria: * Individuals who do not meet eligibility criteria, including individuals who do not speak English or Spanish; * Those who refuse treatment at one of three hospital sites; * Decisionally-challenged adults with cognitive or personality impairment; * Suicidal ideation, or * Intoxication (alcohol or drugs) that might interfere with their ability to consent or participate in the study; * Individuals from vulnerable populations (e.g., inmates or individuals on probation, * homeless, * pregnant women, and * those with auditory impairment. Note: Individuals who become pregnant or develop auditory impairments after they have been randomized to study condition may remain in the study until completion. 2. Caregivers of LC and/or HNC patients Inclusion Criteria: * Primary caregiver of a newly diagnosed LC and/or HNC patient (per criteria for patients); * Over 18 years old; * English and/or Spanish speaking; * Medically underserved, as defined by at least one or several of the following: 1. Low-income: Below 400% of the 2016 Federal poverty levels; 2. Uninsured: No health insurance (public or private insurance); 3. Underinsured: * (c.1) Public insurance (i.e., Medicaid, Medicare exclusive, VA); * (c.2) 10% of annual income spent on out-of-pocket medical expenses for individuals below 200% of the 2016 Federal poverty level. Exclusion criteria: * Individuals who do not meet eligibility criteria, including individuals who do not speak English or Spanish \[at the discretion of the Site Coordinators upon recruitment\]; * Caregivers of patients who refuse treatment at one of three hospital sites. * Decisionally challenged adults with: 1. cognitive or personality impairment, 2. suicidal ideation, or 3. intoxication (alcohol or drugs) that might interfere with their ability to consent or participate in the study \[at the discretion of the Site Coordinators upon recruitment or the Counselor during the intervention\]; * Individuals from: 1. vulnerable populations (e.g., inmates or individuals on probation, homeless, 2. pregnant women, and 3. those with auditory impairment \[at the discretion of the Site Coordinators upon recruitment\]). 4. Individuals who become pregnant or develop auditory impairments after they have been randomized to study condition may remain in the study until completion.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Denver Health Medical CenterDenver, Colorado
  • University of Colorado DenverDenver, Colorado
  • National Jewish HealthDenver, Colorado
  • Saint Joseph HospitalDenver, Colorado
  • Saint Mary's Hospital and Regional Medical CenterGrand Junction, Colorado

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 19, 2021. Always confirm current availability with the study team.

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