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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2013-11-30

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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.

Group Type EXPERIMENTAL

counseling intervention

Intervention Type OTHER

Undergo cognitive behavioral therapy

questionnaire administration

Intervention Type OTHER

Ancillary studies

quality-of-life assessment

Intervention Type PROCEDURE

Ancillary studies

Interventions

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counseling intervention

Undergo cognitive behavioral therapy

Intervention Type OTHER

questionnaire administration

Ancillary studies

Intervention Type OTHER

quality-of-life assessment

Ancillary studies

Intervention Type PROCEDURE

Other Intervention Names

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counseling and communications studies quality of life assessment

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Ellen Hendriksen

Instructor, Psychiatry & Behavioral Science - Behavioral Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ellen Hendriksen

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

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Stanford University

Stanford, California, United States

Site Status

Countries

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United States

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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