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Intervention Development for Anxiety in Metastatic NSCLC Patients and Their Caregivers


N/A
N/A
N/A
Open (Enrolling)
Both
Anxiety Disorder, Recurrent Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

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Trial Information

Intervention Development for Anxiety in Metastatic NSCLC Patients 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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Feasibility, defined as 75% of participants complete at least 5 sessions, 75% of participants complete pre- and post-intervention assessment battery

Outcome Time Frame:

Up to 7 weeks

Safety Issue:

No

Principal Investigator

Ellen Hendriksen

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

LUN0053

NCT ID:

NCT01729689

Start Date:

November 2012

Completion Date:

Related Keywords:

  • Anxiety Disorder
  • Recurrent Non-Small Cell Lung Cancer
  • Stage IV Non-Small Cell Lung Cancer
  • Anxiety Disorders
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

Name

Location

Stanford UniversityStanford, California  94305