Lung Cancer Clinical Trial

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

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).

View Eligibility Criteria

Eligibility Criteria

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:

Low-income: Below 400% of the 2016 Federal poverty levels;
Uninsured: No health insurance (public or private insurance);
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.

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:

Low-income: Below 400% of the 2016 Federal poverty levels;
Uninsured: No health insurance (public or private insurance);
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:

cognitive or personality impairment,
suicidal ideation, or
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:

vulnerable populations (e.g., inmates or individuals on probation, homeless,
pregnant women, and
those with auditory impairment [at the discretion of the Site Coordinators upon recruitment]).
Individuals who become pregnant or develop auditory impairments after they have been randomized to study condition may remain in the study until completion.

Study is for people with:

Lung Cancer

Estimated Enrollment:

535

Study ID:

NCT03016403

Recruitment Status:

Completed

Sponsor:

University of Colorado, Denver

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There are 4 Locations for this study

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Denver Health Medical Center
Denver Colorado, 80204, United States
University of Colorado Denver
Denver Colorado, 80204, United States
National Jewish Health
Denver Colorado, 80206, United States
Saint Joseph Hospital
Denver Colorado, 80218, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction Colorado, 81502, United States

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Estimated Enrollment:

535

Study ID:

NCT03016403

Recruitment Status:

Completed

Sponsor:


University of Colorado, Denver

How clear is this clinincal trial information?

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