NCT01729689

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 14, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 20, 2012

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

August 22, 2014

Status Verified

August 1, 2014

Enrollment Period

1 year

First QC Date

November 14, 2012

Last Update Submit

August 20, 2014

Conditions

Anxiety DisorderRecurrent Non-small Cell Lung CancerStage IV Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

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.

Other: counseling interventionOther: questionnaire administrationProcedure: quality-of-life assessment

Interventions

counseling interventionOTHER

Undergo cognitive behavioral therapy

Also known as: counseling and communications studies
Supportive care (cognitive behavioral therapy)
questionnaire administrationOTHER

Ancillary studies

Supportive care (cognitive behavioral therapy)
quality-of-life assessmentPROCEDURE

Ancillary studies

Also known as: quality of life assessment
Supportive care (cognitive behavioral therapy)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • PATIENTS AND CAREGIVERS:
  • Active, unstable, untreated serious mental illness
  • Other cognitive inability to complete informed consent process or study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Anxiety DisordersCarcinoma, Non-Small-Cell Lung

Interventions

Counseling

Condition Hierarchy (Ancestors)

Mental DisordersCarcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Ellen Hendriksen

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Instructor, Psychiatry & Behavioral Science - Behavioral Medicine

Study Record Dates

First Submitted

November 14, 2012

First Posted

November 20, 2012

Study Start

November 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

August 22, 2014

Record last verified: 2014-08

Locations

US(1)