| ID | Type | Description | Link |
|---|---|---|---|
| R01CA115349 | U.S. NIH Grant/Contract | View source | |
| P30CA008748 | U.S. NIH Grant/Contract | View source | |
| MSKCC-06038 |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Lucille P. Markey Cancer Center at University of Kentucky | OTHER |
| Vanderbilt University | OTHER |
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.
OBJECTIVES:
Primary
Secondary
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.
All patients and physicians are notified of the screening results before the patient leaves the clinic. All patients are offered supportive counseling.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (control) | Experimental | 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 | Experimental | 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. |
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| Arm III | Experimental | 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. |
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| Arm IV | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| counseling intervention | Other |
| ||
| screening questionnaire administration |
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment recommendations for depression made as measured by checklist of recommendations for depression treatment | 2 years | |
| Degree of patient satisfaction with interaction as measured by Medical Interview Satisfaction Scale | 2 years | |
| Overall patient experience as measured by Patient Experience Questionnaire | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Psychological and demographic subsets of patients | 2 years |
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DISEASE CHARACTERISTICS:
Diagnosis of lung cancer
Prescreening distress thermometer score > 3
Zung Self-Rating Depression Scale (ZSDS) score ≥ 44
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| William Breitbart, MD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lucille P. Markey Cancer Center at University of Kentucky | Lexington | Kentucky | 40536-0093 | United States | ||
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| ID | Term |
|---|---|
| D003863 | Depression |
| D008175 | Lung Neoplasms |
| D055752 | Small Cell Lung Carcinoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| ID | Term |
|---|---|
| D003376 | Counseling |
| D000067250 | Psychiatric Rehabilitation |
| ID | Term |
|---|---|
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D003153 | Community Health Services |
| D006296 | Health Services |
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| Other |
|
| study of socioeconomic and demographic variables | Other |
|
| psychosocial assessment and care | Procedure |
|
| Memorial Sloan-Kettering Cancer Center |
| New York |
| New York |
| 10065 |
| United States |
| D009371 |
| Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D005159 | Health Care Facilities Workforce and Services |
| D012046 | Rehabilitation |
| D013812 | Therapeutics |