Lung Cancer Clinical Trial; Depression Screening in Patients With Lung Cancer

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Depression Screening in Patients With Lung Cancer
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), November 2008
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)

Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00404365

Purpose
RATIONALE: Screening tests may help doctors find depression in patients with lung cancer, allow doctors to recommend treatment for depression, and improve the patient's quality of life.

PURPOSE: This randomized clinical trial is studying how well depression screening works when the results are or are not shared with patients with lung cancer and their doctor.



Condition Intervention
Cancer-Related Problem/Condition
Lung Cancer
Other: counseling
Other: screening questionnaire administration
Procedure: psychosocial assessment and care
Procedure: study of socioeconomic and demographic variables




MedlinePlus related topics: Cancer Depression Lung Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Randomized, Double-Blind
Official Title: Maximizing Utilization of Depression Screening in Lung Cancer Patients: A Randomized Trial


Further study details as provided by National Cancer Institute (NCI):


Primary Outcome Measures:
Number of treatment recommendations for depression made as measured by checklist of recommendations for depression treatment [ Designated as safety issue: No ]

Degree of patient satisfaction with interaction as measured by Medical Interview Satisfaction Scale [ Designated as safety issue: No ]

Overall patient experience as measured by Patient Experience Questionnaire [ Designated as safety issue: No ]



Secondary Outcome Measures:
Psychological and demographic subsets of patients [ Designated as safety issue: No ]


Estimated Enrollment: 300
Study Start Date: April 2006
Estimated Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Detailed Description:
OBJECTIVES:

Primary

Determine the impact of depression screening in patients with lung cancer when the results of the screening are made available to the patient, the physician, both, or neither on detection of depression, provision of depression treatment recommendations, and the quality of the doctor-patient interaction from the patient's perspective.
Secondary

Determine psychological and demographic subsets for the impact of depression screening in these patients when the results of the screening are made available to the patient, the physician, both, or neither on the detection of depression, provision of depression treatment recommendations, and the quality of the doctor-patient interaction from the patient's perspective.
OUTLINE: This is a multicenter, randomized, double-blind, single-blind, factorial study. Patients are stratified according to participating center (Memorial Sloan-Kettering Cancer Center vs University of Kentucky Markey Cancer Center). Patients are randomized to 1 of 4 screening arms.

Arm I (control): Patients complete screening questionnaires about their mood and experience with lung cancer once before and once after a visit with their physician. Neither the patient nor physician receives the screening results before the visit.
Arm II: Patients complete screening questionnaires as in arm I. Only the patient receives the screening results before their visit with the physician; the physician remains blinded to the results.
Arm III: Patients complete screening questionnaires as in arm I. Only the physician receives the screening results before their visit with the patient; the patient remains blinded to the results.
Arm IV: Patients complete screening questionnaires as in arm I. Both physician and patient receive the screening results before the visit.
All patients and physicians are notified of the screening results before the patient leaves the clinic. All patients are offered supportive counseling.

PROJECTED ACCRUAL: A total of 300 patients will be accrued for this study.

Eligibility


Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Criteria
DISEASE CHARACTERISTICS:

Diagnosis of lung cancer
Prescreening distress thermometer score > 3
Zung Self-Rating Depression Scale (ZSDS) score ≥ 44

No ZSDS response indicating suicidality
PATIENT CHARACTERISTICS:

Able to understand English
No evidence of cognitive dysfunction that would impair giving consent
PRIOR CONCURRENT THERAPY:

Not specified
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404365


Locations
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536-0093
Contact: Ken Kirsh, PhD 859-323-3849
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10022
Contact: Steven D. Passik, PhD 646-888-0020

Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Investigators
Principal Investigator: Steven D. Passik, PhD Memorial Sloan-Kettering Cancer Center

More Information


Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers: CDR0000516001, MSKCC-06038
Study First Received: November 27, 2006
Last Updated: February 6, 2009
ClinicalTrials.gov Identifier: NCT00404365 [history]
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
depression
extensive stage small cell lung cancer
limited stage small cell lung cancer
recurrent small cell lung cancer
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
recurrent non-small cell lung cancer



Study placed in the following topic categories:
Thoracic Neoplasms
Non-small cell lung cancer
Depression
Depressive Disorder
Recurrence
Behavioral Symptoms
Carcinoma, Small Cell
Respiratory Tract Diseases
Lung Neoplasms
Mental Disorders
Lung Diseases
Mood Disorders
Carcinoma, Non-Small-Cell Lung



Additional relevant MeSH terms:
Neoplasms by Site
Respiratory Tract Neoplasms
Neoplasms



ClinicalTrials.gov processed this record on February 10, 2009


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