Project Summary

This research project is in progress. PCORI will post the research findings on this page within 90 days after the results are final.

What is the research about?

Lung cancer is the leading cause of cancer death among adults in the United States. Some patients with lung cancer also develop head and neck cancer. Both types of cancer can make it hard to breathe, eat, or swallow. Patients with lung and/or head and neck cancers tend to have poorer quality of life, greater distress, and higher risk of suicide than patients with other cancers. Taking care of patients with these cancers can be stressful, and caregivers can become anxious or depressed or have trouble coping.

Patients with lung cancer and head and neck cancer and their caregivers can benefit from mental health services. But many have trouble getting these services, especially if they have low incomes or lack health insurance.

One way to help patients and caregivers who need mental health services is a stepped care program. In stepped care, the amount of mental health services patients receive depends on their needs. Stepped care offers the least intensive, least costly treatment first and increases care if patients’ needs change or past treatments don’t work.

In this study, the research team is adapting a stepped mental health program for medically underserved patients with lung and/or head and neck cancer and their caregivers. The team is looking at how well stepped care improves patient and caregiver mental health compared with standard mental health services.

Who can this research help?

Hospitals can use results of this study when considering ways to offer mental health services to patients with lung and/or head and neck cancer and their caregivers.

What is the research team doing?

The research team is recruiting 440 patients with lung and/or head and neck cancer from four medical centers in Colorado. All patients in the study have low incomes, lack insurance, or have high insurance copays. Patients invite their caregivers to take part in the study with them. The research team is assigning patients and caregivers by chance to receive stepped care or standard mental health services.

Patients and caregivers in stepped care receive mental health services tailored to their symptoms for about six months. Depending on their symptoms, patients and caregivers receive different types of treatment:

  • Below mild symptoms: watchful waiting, in which a doctor monitors symptoms
  • Mild symptoms: a self-help guide
  • Moderate symptoms: training in coping skills
  • Severe symptoms: eight sessions, including cognitive behavioral therapy, a type of treatment that helps people manage pain, depression, and other symptoms by teaching them how to change their patterns of thinking and behavior

Patients and caregivers in the standard care group receive a list of mental health services available at the hospital and at local and national organizations.

The research team is surveying patients and caregivers at study start and again at six weeks and three and six months later. The survey asks about patients’ and caregivers’ depression, anxiety, stress, and coping. The team is also asking patients about their quality of life and caregivers about burden. 

Clinicians, patients, and caregivers are working with the research team to help plan and conduct the study.

Research methods at a glance

Design Elements Description
Design Randomized controlled trial
Population 220 patient-caregiver dyads in which both parties are age 18 or older and have low incomes or are uninsured or underinsured and in which patients are newly diagnosed with lung and/or head and neck cancer 
  • stepped-care intervention
  • standard mental health services

Primary: patient and caregiver depression, anxiety, and coping ability

Secondary: patient health-related quality of life, patient and caregiver stress, caregiver burden

Timeframe 6-month follow-up for primary outcomes

Project Information

Evelinn A. Borrayo, PhD
University of Colorado Denver
A Stepped-Care Intervention to Reduce Disparities in Mental Health Services among Underserved Lung and Head and Neck Cancer Patients and their Caregivers

Key Dates

July 2016
March 2023

Study Registration Information


Award Type
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Populations Populations PCORI is interested in research that seeks to better understand how different clinical and health system options work for different people. These populations are frequently studied in our portfolio or identified as being of interest by our stakeholders. View Glossary
Funding Opportunity Type
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
Research Priority Area
State State The state where the project originates, or where the primary institution or organization is located. View Glossary
Last updated: January 20, 2023