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

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).

Study Overview

• Status: Completed
• Conditions: Cancer, Lung; Cancer, Head and Neck
• Intervention / Treatment: Behavioral: Stepped-Care Intervention; Behavioral: Enhanced Usual Care

• Study Type: Interventional
• Enrollment (Actual): 535
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: Stepped-Care Intervention; The intervention delivered evidence-based CBT and stress management across eight counseling sessions.
Active Comparator: 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.	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.; Other Names: Standard of Care

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Evelinn A Borrayo, PhD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2017
• Primary Completion (Actual): July 17, 2020
• Study Completion (Actual): July 17, 2020

Study Registration Dates

• First Submitted: December 27, 2016
• First Submitted That Met QC Criteria: January 6, 2017
• First Posted (Estimate): January 10, 2017

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: February 24, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Head and Neck Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 16-2621.cc; AD-1511-33395 (Other Grant/Funding Number: PCORI)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No