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

Primary Purpose

Anxiety Disorder, Recurrent Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
counseling intervention
questionnaire administration
quality-of-life assessment
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Anxiety Disorder

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Stanford University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Supportive care (cognitive behavioral therapy)

Arm 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.

Outcomes

Primary Outcome Measures

Feasibility, defined as 75% of participants complete at least 5 sessions, 75% of participants complete pre- and post-intervention assessment battery
Acceptability, based on qualitative analysis of exit interviews

Secondary Outcome Measures

Full Information

First Posted
November 14, 2012
Last Updated
August 20, 2014
Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01729689
Brief Title
Cognitive Behavioral Therapy in Treating Anxiety in Patients With Stage IV Non-Small Cell Lung Cancer and Their Caregivers
Official Title
Intervention Development for Anxiety in Metastatic NSCLC Patients and Their Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorder, Recurrent Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supportive care (cognitive behavioral therapy)
Arm Type
Experimental
Arm 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.
Intervention Type
Other
Intervention Name(s)
counseling intervention
Other Intervention Name(s)
counseling and communications studies
Intervention Description
Undergo cognitive behavioral therapy
Intervention Type
Other
Intervention Name(s)
questionnaire administration
Intervention Description
Ancillary studies
Intervention Type
Procedure
Intervention Name(s)
quality-of-life assessment
Other Intervention Name(s)
quality of life assessment
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
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
Title
Acceptability, based on qualitative analysis of exit interviews
Time Frame
Up to 7 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ellen Hendriksen
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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