Depression Screening in Patients With Lung Cancer

This study has been completed.
Sponsor:
Collaborators:
Lucille P. Markey Cancer Center at University of Kentucky
Vanderbilt University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00404365
First received: November 27, 2006
Last updated: April 29, 2013
Last verified: April 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Maximizing Utilization of Depression Screening in Lung Cancer Patients: A Randomized Trial

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Number of treatment recommendations for depression made as measured by checklist of recommendations for depression treatment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Degree of patient satisfaction with interaction as measured by Medical Interview Satisfaction Scale [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Overall patient experience as measured by Patient Experience Questionnaire [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychological and demographic subsets of patients [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 241
Study Start Date: April 2006
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00404365

Locations
United States, Kentucky
Lucille P. Markey Cancer Center at University of Kentucky
Lexington, Kentucky, United States, 40536-0093
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10065
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Lucille P. Markey Cancer Center at University of Kentucky
Vanderbilt University
Investigators
Principal Investigator: William Breitbart, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00404365     History of Changes
Obsolete Identifiers: NCT00369369
Other Study ID Numbers: Mskcc 06-038, R01CA115349, P30CA008748, MSKCC-06038
Study First Received: November 27, 2006
Last Updated: April 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
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

Additional relevant MeSH terms:
Depression
Depressive Disorder
Lung Neoplasms
Behavioral Symptoms
Mood Disorders
Mental Disorders
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 26, 2014