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

Intervention Development for Anxiety in Metastatic NSCLC Patients and Their Caregivers

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.

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.

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