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Depression Screening in Patients With Lung Cancer

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00404365
Enrollment
241
Registered
2006-11-28
Start date
2006-04-30
Completion date
2012-04-30
Last updated
2013-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

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.

Interventions

OTHERcounseling intervention
OTHERstudy of socioeconomic and demographic variables
PROCEDUREpsychosocial assessment and care

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Lucille P. Markey Cancer Center at University of Kentucky
CollaboratorOTHER
Vanderbilt University
CollaboratorOTHER
Memorial Sloan Kettering Cancer Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frame
Number of treatment recommendations for depression made as measured by checklist of recommendations for depression treatment2 years
Degree of patient satisfaction with interaction as measured by Medical Interview Satisfaction Scale2 years
Overall patient experience as measured by Patient Experience Questionnaire2 years

Secondary

MeasureTime frame
Psychological and demographic subsets of patients2 years

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026