Depression Screening in Patients With Lung Cancer

Not Applicable

Completed

• Conditions: Depression; Lung Cancer
• Interventions: Other: counseling intervention; Other: screening questionnaire administration; Other: study of socioeconomic and demographic variables; Procedure: psychosocial assessment and care

• Registration Number: NCT00404365
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-11-27
• Study First Submitted QC: 2006-11-27
• Study First Posted: 2006-11-28
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-29
• Last Update Posted: 2013-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 241

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm I (control)	counseling intervention	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 I (control)	screening questionnaire administration	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 I (control)	study of socioeconomic and demographic variables	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 I (control)	psychosocial assessment and care	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	counseling intervention	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 II	screening questionnaire administration	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 II	study of socioeconomic and demographic variables	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 II	psychosocial assessment and care	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	counseling intervention	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 III	screening questionnaire administration	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 III	study of socioeconomic and demographic variables	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 III	psychosocial assessment and care	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	counseling intervention	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.
Arm IV	screening questionnaire administration	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.
Arm IV	study of socioeconomic and demographic variables	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.
Arm IV	psychosocial assessment and care	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.

Primary Outcome Measures

Name	Time	Method
Degree of patient satisfaction with interaction as measured by Medical Interview Satisfaction Scale	2 years
Number of treatment recommendations for depression made as measured by checklist of recommendations for depression treatment	2 years
Overall patient experience as measured by Patient Experience Questionnaire	2 years

Secondary Outcome Measures

Name	Time	Method
Psychological and demographic subsets of patients	2 years

Trial Locations

Locations (2)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States

Lucille P. Markey Cancer Center at University of Kentucky; 🇺🇸 Lexington, Kentucky, United States