Intervention Development for Anxiety in Metastatic NSCLC Patients and Their Caregivers
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Anxiety Disorder
- Sponsor
- Stanford University
- Enrollment
- 13
- Locations
- 1
- Primary Endpoint
- Feasibility, defined as 75% of participants complete at least 5 sessions, 75% of participants complete pre- and post-intervention assessment battery
- Status
- Completed
- Last Updated
- 11 years ago
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.
Investigators
Ellen Hendriksen
Instructor, Psychiatry & Behavioral Science - Behavioral Medicine
Stanford University
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
Outcomes
Primary Outcomes
Feasibility, defined as 75% of participants complete at least 5 sessions, 75% of participants complete pre- and post-intervention assessment battery
Time Frame: Up to 7 weeks
Acceptability, based on qualitative analysis of exit interviews
Time Frame: Up to 7 weeks