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

Not Applicable

Completed

Conditions: Cancer, Head and Neck
Cancer, Lung

Interventions: Behavioral: Stepped-Care Intervention
Behavioral: Enhanced Usual Care

Registration Number: NCT03016403

Lead Sponsor: University of Colorado, Denver

Brief 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).

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 535

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.

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stepped-Care Intervention	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.
Enhanced Usual Care	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.

Primary Outcome Measures

Name	Time	Method
Change in Coping-Patients	6-months	Coping Self-Efficacy (26 items). Scores can rage from 0 to 260. Higher score corresponds to better outcome.
Symptoms of Anxiety-Patients	6-months	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.
Symptoms of Depression-Patients	6-months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Coping-Caregivers	6-months	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.
Health-Related Quality of Life-Patients	6-months	FACT-G version 4 (27 items). The range is 0-108. Higher values indicate better QOL.
Perceived Stress-Patients	6-months	Perceived Stress Scale (PSS) (14 items). The range of scores is 0-40. Higher values indicate higher stress.
Perceived Stress-Caregivers	6-months	Perceived Stress Scale (PSS) (14 items). The range is from 0 to 40. Higher values indicate higher stress.
Symptoms of Depression-Caregivers	6-months	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.
Caregiving Burden-Caregivers	6-months	Zarit Burden Interview (ZBI) (12 items). The range of scores is 0-48. Higher scores represent higher burden.
Symptoms of Anxiety-Caregivers	6-months	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.

Trial Locations

Locations (5): University of Colorado Denver
🇺🇸
Denver, Colorado, United States
Saint Mary's Hospital and Regional Medical Center
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Grand Junction, Colorado, United States
Saint Joseph Hospital
🇺🇸
Denver, Colorado, United States
Denver Health Medical Center
🇺🇸
Denver, Colorado, United States
National Jewish Health
🇺🇸
Denver, Colorado, United States