Cognitive Behavioral Therapy in Treating Anxiety in Patients With Stage IV Non-Small Cell Lung Cancer and Their Caregivers

Study Overview
=================
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.

Official Title
-----------------
Intervention Development for Anxiety in Metastatic NSCLC Patients and Their Caregivers

Conditions
-----------------
Anxiety Disorder, Recurrent Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Other: counseling intervention
* Other: questionnaire administration
* Procedure: quality-of-life assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (cognitive behavioral therapy)<br>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. | Other: counseling intervention<br>* Undergo cognitive behavioral therapy<br>* Other names: counseling and communications studies;Other: questionnaire administration<br>* Ancillary studies<br>Procedure: quality-of-life assessment<br>* Ancillary studies<br>* Other names: quality of life assessment;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |