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

Stanford University

Status: Completed

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

Treatments: Procedure: quality-of-life assessment; Other: questionnaire administration; Other: counseling intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01729689

NCI-2012-02096 (Registry Identifier)

25339

LUN0053

Details and patient eligibility

About

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.

Full 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.

Enrollment: 13 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

Supportive care (cognitive behavioral therapy)

Experimental group

Description:

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.

Treatment:

Other: questionnaire administration

Other: counseling intervention

Procedure: quality-of-life assessment