Clinical trial NCT00404365: Depression Screening in Patients With Lung Cancer
Official title: Maximizing Utilization of Depression Screening in Lung Cancer Patients: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lung Cancer
Keywords: 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
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Lucille P. Markey Cancer Center at University of Kentucky
name: Vanderbilt University
First posted: 2006-11-28
Enrollment: 241
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

Eligibility 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

Primary outcomes:
measure: Number of treatment recommendations for depression made as measured by checklist of recommendations for depression treatment
timeFrame: 2 years
measure: Degree of patient satisfaction with interaction as measured by Medical Interview Satisfaction Scale
timeFrame: 2 years
measure: Overall patient experience as measured by Patient Experience Questionnaire
timeFrame: 2 years
Secondary outcomes:
measure: Psychological and demographic subsets of patients
timeFrame: 2 years
Other outcomes:
Locations:
city: Lexington
country: United States
facility: Lucille P. Markey Cancer Center at University of Kentucky
state: Kentucky
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: William Breitbart, MD
role: PRINCIPAL_INVESTIGATOR
References: