Anxiety Disorder, Recurrent Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
Conditions
Brief summary
This pilot clinical trial studies cognitive behavioral therapy in treating anxiety in patients with stage IV non-small cell lung cancer and their caregivers. Cognitive behavioral therapy may reduce anxiety and improve the well-being and quality of life of patients who have stage IV non-small cell lung cancer and their caregivers.
Detailed description
PRIMARY OBJECTIVES: I. To identify, through both quantitative and qualitative methods, clinical correlates of anxiety and points of intervention to reduce anxiety in patients with late-stage lung cancer and their primary caregivers. II. To apply these findings to develop a brief dyadic intervention based on Cognitive Behavioral Therapy (CBT) to reduce anxiety in late-stage lung cancer patients and their primary caregivers. III. To evaluate the feasibility and acceptability of the pilot intervention through number of completed visits and assessment pre- and post- intervention. OUTLINE: Participants undergo cognitive behavioral therapy over 1 hour once weekly for a total of 6 sessions. Sessions are tailored to patient and caregiver cognitions and approach and avoidance behaviors. After completion of study treatment, participants are followed up at 1 week.
Interventions
OTHERcounseling intervention
Undergo cognitive behavioral therapy
OTHERquestionnaire administration
Ancillary studies
PROCEDUREquality-of-life assessment
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Diagnosis of stage IV non-small cell lung cancer * At least 6 weeks post-diagnosis * Current symptoms of anxiety (e.g., Hamilton Rating Scale for Anxiety \[HAM-A\] \>=14) * Ability to understand and the willingness to sign a written informed consent document * CAREGIVER: Identified by patient as primary caregiver * CAREGIVER: At least 14 hours/week spent caring for patient * CAREGIVER: Current symptoms of anxiety (e.g., HAM-A \>= 14) * CAREGIVER: Ability to understand and the willingness to sign a written informed consent document
Exclusion criteria
* PATIENTS AND CAREGIVERS: * Active, unstable, untreated serious mental illness * Other cognitive inability to complete informed consent process or study procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility, defined as 75% of participants complete at least 5 sessions, 75% of participants complete pre- and post-intervention assessment battery | Up to 7 weeks |
| Acceptability, based on qualitative analysis of exit interviews | Up to 7 weeks |
Countries
United States
Outcome results
None listed