Stepped-Care Intervention
BehavioralThe intervention delivered evidence-based CBT and stress management across eight counseling sessions.
NCT Number: NCT03016403
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).
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Denver Health Medical Center, Denver, Colorado, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Note: Individuals who become pregnant or develop auditory impairments after they have been randomized to study condition may remain in the study until completion.
Inclusion criteria
Exclusion criteria
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.
Other names: Standard of Care
Time frame: 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.
Time frame: 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.
Time frame: 6-months
Coping Self-Efficacy (26 items). Scores can rage from 0 to 260. Higher score corresponds to better outcome.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6-months
FACT-G version 4 (27 items). The range is 0-108. Higher values indicate better QOL.
Time frame: 6-months
Perceived Stress Scale (PSS) (14 items). The range of scores is 0-40. Higher values indicate higher stress.
Time frame: 6-months
Perceived Stress Scale (PSS) (14 items). The range is from 0 to 40. Higher values indicate higher stress.
Time frame: 6-months
Zarit Burden Interview (ZBI) (12 items). The range of scores is 0-48. Higher scores represent higher burden.
University of Colorado, Denver
Other
A Stepped-Care Intervention to Reduce Disparities in Mental Health Services Among Underserved Lung and Head and Neck Cancer Patients and Their Caregivers
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