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

Study Overview
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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).

Official Title
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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

Conditions
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Cancer, Lung, Cancer, Head and Neck

Intervention / Treatment
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* Behavioral: Stepped-Care Intervention
* Behavioral: Enhanced Usual Care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stepped-Care Intervention<br>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. | Behavioral: Stepped-Care Intervention<br>* The intervention delivered evidence-based CBT and stress management across eight counseling sessions.<br>|
| Active Comparator: Enhanced Usual Care<br>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. | Behavioral: Enhanced Usual Care<br>* Consists of a list of standard mental health resources offered at the participating hospital, local community, or national non-profit organizations.<br>* Other names: Standard of Care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms of Depression-Patients | Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer (CA) Form v1.0 - Depression (30 items). The range is from 8 to 40. Higher score indicates worse outcome (higher depression). Raw scores were used in analyses. | 6-months | 
| Symptoms of Anxiety-Patients | Patient-Reported Outcomes Measurement Information System, Anxiety (PROMIS-Ca) Form v1.0- Anxiety (22 items). The range of scores is between 8 and 40. The raw scores were used. Higher score corresponds to worse outcome. | 6-months | 
| Change in Coping-Patients | Coping Self-Efficacy (26 items). Scores can rage from 0 to 260. Higher score corresponds to better outcome. | 6-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Coping-Caregivers | Coping Self-Efficacy (26 items). Higher score corresponds to better outcome. Scores can rage from 0 to 260. The number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively. | 6-months | 
| Symptoms of Anxiety-Caregivers | PROMIS Form v1.0 - Anxiety (29 items). The range of scores is from 8 to 40. Higher score indicates worse outcome (higher anxiety). Raw scores were used in analyses. The number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively. | 6-months | 
| Symptoms of Depression-Caregivers | PROMIS Form v1.0 - Depression (28 items). The range is from 8 to 40. Higher score indicates worse outcome (higher depression). Raw scores were used in analyses. The number of caregivers randomized and analyzed was 118 and 131 in the enhanced usual care and intervention groups, respectively. | 6-months | 
| Health-Related Quality of Life-Patients | FACT-G version 4 (27 items). The range is 0-108. Higher values indicate better QOL. | 6-months | 
| Perceived Stress-Patients | Perceived Stress Scale (PSS) (14 items). The range of scores is 0-40. Higher values indicate higher stress. | 6-months | 
| Perceived Stress-Caregivers | Perceived Stress Scale (PSS) (14 items). The range is from 0 to 40. Higher values indicate higher stress. | 6-months | 
| Caregiving Burden-Caregivers | Zarit Burden Interview (ZBI) (12 items). The range of scores is 0-48. Higher scores represent higher burden. | 6-months |