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



Status:Recruiting
Conditions:Lung Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/30/2019
Start Date:March 24, 2017
End Date:March 2020
Contact:Alice A Bradley, MA
Email:alice.bradley@ucdenver.edu
Phone:303-315-2514

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A Stepped-Care Intervention to Reduce Disparities in Mental Health Services Among Underserved Lung and Head and Neck Cancer Patients and Their 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).


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.
We found this trial at
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1375 19th Avenue
Denver, Colorado 80218
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Denver, Colorado 80291
Principal Investigator: David Raben, MD
Phone: 303-315-2514
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777 Bannock St
Denver, Colorado 80204
(303) 436-6000
Principal Investigator: Sonia Okuyama, MD
Phone: 303-602-6049
Denver Health Medical Center Denver Health is a comprehensive, integrated organization providing level one care...
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1400 Jackson St
Denver, Colorado 80206
(303) 388-4461
Principal Investigator: Fred Wamboldt, MD
Phone: 303-398-1135
National Jewish Health National Jewish Health is known worldwide for treatment of patients with respiratory,...
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Grand Junction, Colorado 81502
Principal Investigator: Marty Jacobson, PhD
Phone: 970-298-1822
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Grand Junction, CO
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