Clinical trial · Interventional
Cognitive Behavioral Therapy in Treating Anxiety in Patients With Stage IV Non-Small Cell Lung Cancer and Their Caregivers
Intervention Development for Anxiety in Metastatic NSCLC Patients and Their Caregivers
NCT01729689CI-TRIAL-00015452completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anxiety Disorder | — | UNRESOLVED | — |
| Recurrent Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| counseling intervention | Other | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supportive care (cognitive behavioral therapy)
- 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.
- interventionNames
- Other: counseling intervention
- Other: questionnaire administration
- Procedure: quality-of-life assessment
Primary outcomes (2)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.