Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
241 participants
INTERVENTIONAL
2006-04-30
2012-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DOUBLE
Study Groups
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Arm I (control)
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.
counseling intervention
screening questionnaire administration
study of socioeconomic and demographic variables
psychosocial assessment and care
Arm II
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.
counseling intervention
screening questionnaire administration
study of socioeconomic and demographic variables
psychosocial assessment and care
Arm III
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.
counseling intervention
screening questionnaire administration
study of socioeconomic and demographic variables
psychosocial assessment and care
Arm IV
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.
counseling intervention
screening questionnaire administration
study of socioeconomic and demographic variables
psychosocial assessment and care
Interventions
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counseling intervention
screening questionnaire administration
study of socioeconomic and demographic variables
psychosocial assessment and care
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Lucille P. Markey Cancer Center at University of Kentucky
OTHER
Vanderbilt University
OTHER
Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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William Breitbart, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Countries
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Other Identifiers
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MSKCC-06038
Identifier Type: -
Identifier Source: secondary_id
Mskcc 06-038
Identifier Type: -
Identifier Source: org_study_id
NCT00369369
Identifier Type: -
Identifier Source: nct_alias
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