Depression Screening in Patients With Lung Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Maximizing Utilization of Depression Screening in Lung Cancer Patients: A Randomized Trial

Conditions
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Depression, Lung Cancer

Intervention / Treatment
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* Other: counseling intervention
* Other: screening questionnaire administration
* Other: study of socioeconomic and demographic variables
* Procedure: psychosocial assessment and care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (control)<br>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. | Other: counseling intervention<br> <br> Other: screening questionnaire administration<br> <br> Other: study of socioeconomic and demographic variables<br> <br> Procedure: psychosocial assessment and care<br> <br> |
| Experimental: Arm II<br>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. | Other: counseling intervention<br> <br> Other: screening questionnaire administration<br> <br> Other: study of socioeconomic and demographic variables<br> <br> Procedure: psychosocial assessment and care<br> <br> |
| Experimental: Arm III<br>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. | Other: counseling intervention<br> <br> Other: screening questionnaire administration<br> <br> Other: study of socioeconomic and demographic variables<br> <br> Procedure: psychosocial assessment and care<br> <br> |
| Experimental: Arm IV<br>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. | Other: counseling intervention<br> <br> Other: screening questionnaire administration<br> <br> Other: study of socioeconomic and demographic variables<br> <br> Procedure: psychosocial assessment and care<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychological and demographic subsets of patients |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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