Results Summary
What was the research about?
Due to problems like difficulty breathing, eating, or swallowing, patients with lung or head and neck cancer and their caregivers often have anxiety, depression, or trouble coping. People with low incomes or with little or no health insurance may not be able to get needed mental health care.
In this study, the research team tested a stepped-care program for treating emotional distress in patients and their caregivers. In stepped care, people received services based on their level of distress, or step. They could also receive care at a higher step if needed. The steps were:
- Step 1: People with no symptoms of distress had one orientation session and monitoring for new symptoms. They didn’t receive treatment.
- Step 2: People with mild symptoms had the care in step 1 plus one session with a counselor to review a self-help guide about coping and managing stress.
- Step 3: People with moderate symptoms had the care in steps 1 and 2 plus two training sessions with a counselor to learn about ways to cope.
- Step 4: People with severe symptoms had the care in steps 1–3 plus four sessions with a counselor to help change responses to emotional distress.
The research team compared stepped care plus usual care versus usual care alone.
What were the results?
After six months, compared with usual care alone, patients in stepped care had:
- Improvements in depression, anxiety, and quality of life, but not enough to be meaningful for patients
- Better coping skills
- Similar levels of stress
Compared with usual care alone, caregivers in stepped care had:
- Similar levels of depression, anxiety, and coping skills
- Less stress and caregiver burden
Who was in the study?
The study included 286 patients with lung or head and neck cancer receiving care at one of four hospitals in Colorado, and 249 caregivers. All had low incomes or little or no health insurance. Among patients, 86 percent were White, 5 percent were Black, 6 percent didn’t report a race, and 4 percent selected other; 21 percent were Hispanic. The average age was 66, and 58 percent were men.
What did the research team do?
The research team assigned patients and caregivers by chance to receive stepped care plus usual care or usual care alone. In usual care, patients received a list of mental health resources, providers, and support groups. Patients and caregivers could take part in the study together or separately.
Patients and caregivers completed surveys at the start of the study and six months later.
Cancer survivors, caregivers, and clinicians gave input throughout the study.
What were the limits of the study?
This study took place in one state; most people in the study were White. Results may differ in other places or for people of other racial backgrounds.
Future research could see if more intense treatment would reduce distress.
How can people use the results?
Hospitals can use these results when considering ways to provide mental health care for patients with cancer and their caregivers.
Professional Abstract
Objective
To compare the effectiveness of stepped care plus enhanced usual care, versus enhanced usual care alone, in decreasing emotional distress and improving coping self-efficacy among patients with lung or head and neck cancer and their caregivers
Study Design
Design Element | Description |
---|---|
Design | Randomized controlled trial |
Population | 286 patients with lung cancer or head and neck cancer and 249 caregivers; all had low incomes or were uninsured or underinsured with limited access to mental health care |
Interventions/ Comparators |
|
Outcomes |
Primary: emotional distress, including symptoms of depression and anxiety, and coping self-efficacy Secondary: patient health-related quality of life, patient- and caregiver-perceived stress, and caregiver burden |
Timeframe | 6-month follow-up for primary outcomes |
This randomized controlled trial compared stepped care plus enhanced usual care with enhanced care alone to address emotional distress among patients with lung or head and neck cancer and their caregivers.
Researchers randomly assigned patients and caregivers to receive stepped care plus enhanced usual care or enhanced usual care alone. Patients and caregivers could participate together or independently.
In stepped care, patients and caregivers received treatment based on their reported level of emotional distress. People received all services at and below their designated step and could move to a more intensive step as needed. Steps included:
- Step 1: People with no symptoms received close monitoring plus an orientation session (one session).
- Step 2: People with mild symptoms also received one session with a counselor to review a self-help guide about stress management and coping skills (two sessions total).
- Step 3: People with moderate symptoms also received two training sessions with a counselor on coping strategies (four sessions total).
- Step 4: People with severe symptoms also received four cognitive behavioral therapy sessions with a counselor on changing emotional and behavioral responses to stressors (eight sessions total).
Enhanced usual care included information about mental health resources, support groups, and mental healthcare providers.
The study included 286 patients with lung or head and neck cancer receiving care at one of four hospitals in Colorado and 249 caregivers. All participants had low incomes or were uninsured or underinsured. Among patients, 86% were White, 5% were Black, 6% did not report a race, and 4% selected other; 21% were Hispanic. The average age was 66, and 58% were male.
Participants completed surveys at baseline and again six weeks, three months, and six months later.
Cancer survivors, caregivers, and clinicians provided input throughout the study.
Results
Patients. At six months, compared with enhanced usual care alone, patients who also received stepped care had:
- Statistically significant but not clinically meaningful differences in depression symptoms (p=0.006), anxiety symptoms (p=0.02), and health-related quality of life (p=0.01)
- Higher coping self-efficacy (p=0.006)
- Similar perceived stress
Caregivers. At six months, compared with enhanced usual care alone, caregivers who also received stepped care had:
- No significant differences in depression symptoms, anxiety symptoms, or coping self-efficacy
- Lower perceived stress (p=0.03) and caregiver burden (p=0.004)
Limitations
This study took place in one state; most participants were White. Results may differ in other states or among people of other racial backgrounds.
Conclusions and Relevance
In this study, compared with enhanced usual care, stepped care reduced patients’ and caregivers’ emotional distress, but these changes did not meet the threshold for clinically meaningful difference. Patient coping self-efficacy and caregiver-perceived stress and burden improved.
Future Research Needs
Future research could explore whether more intense treatment through stepped care would reduce emotional distress among patients with cancer and their caregivers.
Final Research Report
This project's final research report is expected to be available by January 2024.
Peer-Review Summary
The Peer-Review Summary for this project will be posted here soon.
Project Information
Patient / Caregiver Partners
No information provided by awardee
Other Stakeholder Partners
- Evelinn Borrayo, University of Colorado Denver
- Kirtsin Kilbourn, University of Colorado Denver
- Davis Raben, University of Colorado Denver
- Jeanette Waxmonsky, University of Colorado Denver
- Sarah Schmiege, University of Colorado Denver
- Sonia Okuyama-Saski, Denver Health and Hospitals Authority
- Robert Swaney, Denver Health and Hospitals Authority
- Jana Lomax, Cancer Centers of Colorado at Saint Joseph Hospital
- Gregory Britt, Cancer Centers of Colorado at Saint Joseph Hospital
- Marty Jacobson, St. Mary’s Hospital & Medical Center
- Steven Emmons, St. Mary’s Hospital & Medical Center
- Vernon King, St. Mary’s Hospital & Medical Center