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

Stage IV Non-small Cell Lung Cancer Clinical Trial

Official title:

Intervention Development for Anxiety in Metastatic NSCLC Patients and Their Caregivers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01729689
• Other study ID #: LUN0053
• Secondary ID: NCI-2012-0209625
• Status: Completed
• Phase: N/A
• First received: November 14, 2012
• Last updated: August 20, 2014
• Start date: November 2012
• Est. completion date: November 2013

Study information

• Verified date: August 2014
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Anxiety Disorder
• Anxiety Disorders
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Recurrent Non-small Cell Lung Cancer
• Stage IV Non-small Cell Lung Cancer

Intervention

Other:
• counseling intervention
Undergo cognitive behavioral therapy
• questionnaire administration
Ancillary studies

Procedure:
• quality-of-life assessment
Ancillary studies

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Acceptability, based on qualitative analysis of exit interviews		Up to 7 weeks	No