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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-02096 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 25339 | Other Identifier | Stanford IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (cognitive behavioral therapy) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| counseling intervention | Other | Undergo cognitive behavioral therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility, defined as 75% of participants complete at least 5 sessions, 75% of participants complete pre- and post-intervention assessment battery | Up to 7 weeks | |
| Acceptability, based on qualitative analysis of exit interviews | Up to 7 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ellen Hendriksen | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States |
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| questionnaire administration | Other | Ancillary studies |
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| quality-of-life assessment | Procedure | Ancillary studies |
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|
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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