Depression Screening in Patients With Lung Cancer

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT00404365

Collaborator

National Cancer Institute (NCI) (NIH), Lucille P. Markey Cancer Center at University of Kentucky (Other), Vanderbilt University (Other)

241

Enrollment

Locations

Arms

Duration (Months)

120.5

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Lung Cancer	Other: counseling intervention Other: screening questionnaire administration Other: study of socioeconomic and demographic variables Procedure: psychosocial assessment and care	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

241 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Official Title:

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

Study Start Date :

Apr 1, 2006

Actual Primary Completion Date :

Apr 1, 2012

Actual Study Completion Date :

Apr 1, 2012

Arms and Interventions

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.	Other: counseling intervention Other: screening questionnaire administration Other: study of socioeconomic and demographic variables Procedure: psychosocial assessment and care
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.	Other: counseling intervention Other: screening questionnaire administration Other: study of socioeconomic and demographic variables Procedure: psychosocial assessment and care
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.	Other: counseling intervention Other: screening questionnaire administration Other: study of socioeconomic and demographic variables Procedure: psychosocial assessment and care
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.	Other: counseling intervention Other: screening questionnaire administration Other: study of socioeconomic and demographic variables Procedure: psychosocial assessment and care

Outcome Measures

Primary Outcome Measures

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

Psychological and demographic subsets of patients [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Lucille P. Markey Cancer Center at University of Kentucky	Lexington	Kentucky	United States	40536-0093
2	Memorial Sloan-Kettering Cancer Center	New York	New York	United States	10065