Clinical trial NCT01729689: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorder
Recurrent Non-small Cell Lung Cancer
Stage IV Non-small Cell Lung Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-11-20
Enrollment: 13
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Feasibility, defined as 75% of participants complete at least 5 sessions, 75% of participants complete pre- and post-intervention assessment battery
timeFrame: Up to 7 weeks
measure: Acceptability, based on qualitative analysis of exit interviews
timeFrame: Up to 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Ellen Hendriksen
role: PRINCIPAL_INVESTIGATOR
References: