Cognitive Behavioral Therapy in Treating Anxiety in Patients With Stage IV Non-Small Cell Lung Cancer and Their Caregivers
NCT ID: NCT01729689
Last Updated: 2014-08-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
13 participants
INTERVENTIONAL
2012-11-30
2013-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Supportive care (cognitive behavioral therapy)
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.
counseling intervention
Undergo cognitive behavioral therapy
questionnaire administration
Ancillary studies
quality-of-life assessment
Ancillary studies
Interventions
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counseling intervention
Undergo cognitive behavioral therapy
questionnaire administration
Ancillary studies
quality-of-life assessment
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Active, unstable, untreated serious mental illness
* Other cognitive inability to complete informed consent process or study procedures
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Stanford University
OTHER
Responsible Party
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Ellen Hendriksen
Instructor, Psychiatry & Behavioral Science - Behavioral Medicine
Principal Investigators
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Ellen Hendriksen
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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Stanford University
Stanford, California, United States
Countries
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Other Identifiers
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NCI-2012-02096
Identifier Type: REGISTRY
Identifier Source: secondary_id
25339
Identifier Type: OTHER
Identifier Source: secondary_id
LUN0053
Identifier Type: -
Identifier Source: org_study_id
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