Skip to main content
OpenTrials
Completed

NCT Number: NCT01729689

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

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

counseling intervention

Other

Undergo cognitive behavioral therapy

Other names: counseling and communications studies

Questionnaire Administration

Other

Ancillary studies

quality-of-life assessment

Procedure

Ancillary studies

Other names: quality of life assessment

Primary outcomes

  1. 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

  2. Acceptability, based on qualitative analysis of exit interviews

    Time frame: Up to 7 weeks

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Intervention Development for Anxiety in Metastatic NSCLC Patients and Their Caregivers

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 20, 2012
Registry last updated
Aug 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.