Depression Screening in Patients With Lung Cancer

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00404365
• Other study ID #: Mskcc 06-038
• Secondary ID: R01CA115349P30CA
• Status: Completed
• Phase: N/A
• First received: November 27, 2006
• Last updated: April 29, 2013
• Start date: April 2006
• Est. completion date: April 2012

Study information

• Verified date: April 2013
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT00369369

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• counseling intervention

• screening questionnaire administration

• study of socioeconomic and demographic variables

Procedure:
• psychosocial assessment and care

Locations

Country	Name	City	State
United States	Lucille P. Markey Cancer Center at University of Kentucky	Lexington	Kentucky
United States	Memorial Sloan-Kettering Cancer Center	New York	New York

Sponsors (4)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Lucille P. Markey Cancer Center at University of Kentucky, National Cancer Institute (NCI), Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of treatment recommendations for depression made as measured by checklist of recommendations for depression treatment		2 years	No
Primary	Degree of patient satisfaction with interaction as measured by Medical Interview Satisfaction Scale		2 years	No
Primary	Overall patient experience as measured by Patient Experience Questionnaire		2 years	No
Secondary	Psychological and demographic subsets of patients		2 years	No