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

Not Applicable

Completed

• Conditions: Anxiety Disorder; Recurrent Non-small Cell Lung Cancer; Stage IV Non-small Cell Lung Cancer
• Interventions: Other: counseling intervention; Other: questionnaire administration; Procedure: quality-of-life assessment

• Registration Number: NCT01729689
• Lead Sponsor: Stanford University

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.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2012-11-14
• Study First Submitted QC: 2012-11-19
• Study First Posted: 2012-11-20
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-20
• Last Update Posted: 2014-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

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

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Exclusion Criteria

• PATIENTS AND CAREGIVERS:
• Active, unstable, untreated serious mental illness
• Other cognitive inability to complete informed consent process or study procedures

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (cognitive behavioral therapy)	counseling intervention	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.
Supportive care (cognitive behavioral therapy)	quality-of-life assessment	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.
Supportive care (cognitive behavioral therapy)	questionnaire administration	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States