Depression Screening in Patients With Lung Cancer

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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Lung Cancer
• Intervention / Treatment: Procedure: psychosocial assessment and care; Other: counseling intervention; Other: study of socioeconomic and demographic variables; Other: screening questionnaire administration

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.

• Study Type: Interventional
• Enrollment (Actual): 241
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536-0093
      • Lucille P. Markey Cancer Center at University of Kentucky
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan-Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: psychosocial assessment and care; Other: counseling intervention; Other: study of socioeconomic and demographic variables; Other: screening questionnaire administration
Experimental: 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.	Procedure: psychosocial assessment and care; Other: counseling intervention; Other: study of socioeconomic and demographic variables; Other: screening questionnaire administration
Experimental: 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.	Procedure: psychosocial assessment and care; Other: counseling intervention; Other: study of socioeconomic and demographic variables; Other: screening questionnaire administration
Experimental: 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.	Procedure: psychosocial assessment and care; Other: counseling intervention; Other: study of socioeconomic and demographic variables; Other: screening questionnaire administration

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborators: National Cancer Institute (NCI); Vanderbilt University; Lucille P. Markey Cancer Center at University of Kentucky
• Investigators: Principal Investigator: William Breitbart, MD, Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start: April 1, 2006
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): April 1, 2012

Study Registration Dates

• First Submitted: November 27, 2006
• First Submitted That Met QC Criteria: November 27, 2006
• First Posted (Estimate): November 28, 2006

Study Record Updates

• Last Update Posted (Estimate): May 1, 2013
• Last Update Submitted That Met QC Criteria: April 29, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: recurrent non-small cell lung cancer; extensive stage small cell lung cancer; recurrent 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; depression; stage I non-small cell lung cancer; stage II non-small cell lung cancer; limited stage small cell lung cancer
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Respiratory Tract Diseases; Mood Disorders; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Depression; Depressive Disorder; Lung Neoplasms
• Other Study ID Numbers: Mskcc 06-038; P30CA008748 (U.S. NIH Grant/Contract); R01CA115349 (U.S. NIH Grant/Contract); MSKCC-06038