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

Study summary

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).

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Key things to know

Main goalSupportive Care

This describes the study’s primary purpose.

What is being studiedStepped-Care Intervention and Enhanced Usual Care

The study team can explain what participation involves.

Who it may be forCancer, Lung · Cancer, Head and Neck

These are broad labels—not an eligibility decision.

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

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?5 U.S. locations

Locations may change over time.

Who runs it?University of Colorado, Denver

Study sponsor

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

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How this study is categorized

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

Treatment approach

Supportive or behavioral care→

Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria

1. LC and HNC patients:
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.

Reasons someone may not be able to joinExclusion 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.

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

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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