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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

535 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-03

Study Completion Date

2020-07-17

Brief Summary

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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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Detailed Description

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Conditions

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Cancer, Lung Cancer, Head and Neck

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Stepped-Care Intervention

Intervention strategies are grounded in evidence-based Cognitive Behavioral Therapy (CBT), that includes stress management and relaxation treatment strategies and coping skills training. Treatment strategies have been adapted from the Transactional Model of Stress and Coping (TMSC), a theoretical model that predicts that individuals who are able to cope and adapt to the stress related to cancer treatment or caregiving will report less psychological distress than those unable to cope.

Group Type EXPERIMENTAL

Stepped-Care Intervention

Intervention Type BEHAVIORAL

The intervention delivered evidence-based CBT and stress management across eight counseling sessions.

Enhanced Usual Care

Denver Health, St. Mary's and St. Joseph's hospitals provide supportive mental health care for patients such as printed materials, support groups, crisis counseling, and specialized care (e.g., psychiatric medication). Because the amount of usual mental health care that each patient receives varies at each site, the investigators will standardize and monitor the usual care arm across the three sites with an enhanced usual care condition.

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type BEHAVIORAL

Consists of a list of standard mental health resources offered at the participating hospital, local community, or national non-profit organizations.

Interventions

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Stepped-Care Intervention

The intervention delivered evidence-based CBT and stress management across eight counseling sessions.

Intervention Type BEHAVIORAL

Enhanced Usual Care

Consists of a list of standard mental health resources offered at the participating hospital, local community, or national non-profit organizations.

Intervention Type BEHAVIORAL

Other Intervention Names

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Standard of Care

Eligibility Criteria

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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.

* 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;
* 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

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No