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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
535
The intervention delivered evidence-based CBT and stress management across eight counseling sessions.
Consists of a list of standard mental health resources offered at the participating hospital, local community, or national non-profit organizations.
Denver Health Medical Center
Denver, Colorado, United States
University of Colorado Denver
Denver, Colorado, United States
National Jewish Health
Denver, Colorado, United States
Saint Joseph Hospital
Denver, Colorado, United States
Saint Mary's Hospital and Regional Medical Center
Grand Junction, Colorado, United States
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.
Time frame: 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.
Time frame: 6-months
Change in Coping-Patients
Coping Self-Efficacy (26 items). Scores can rage from 0 to 260. Higher score corresponds to better outcome.
Time frame: 6-months
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.
Time frame: 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.
Time frame: 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.
Time frame: 6-months
Health-Related Quality of Life-Patients
FACT-G version 4 (27 items). The range is 0-108. Higher values indicate better QOL.
Time frame: 6-months
Perceived Stress-Patients
Perceived Stress Scale (PSS) (14 items). The range of scores is 0-40. Higher values indicate higher stress.
Time frame: 6-months
Perceived Stress-Caregivers
Perceived Stress Scale (PSS) (14 items). The range is from 0 to 40. Higher values indicate higher stress.
Time frame: 6-months
Caregiving Burden-Caregivers
Zarit Burden Interview (ZBI) (12 items). The range of scores is 0-48. Higher scores represent higher burden.
Time frame: 6-months
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