NCT Number: NCT00404365
Depression Screening in Patients With Lung Cancer
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.
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Lucille P. Markey Cancer Center at University of Kentucky, Lexington, Kentucky, United States
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
screening questionnaire administration
Otherstudy of socioeconomic and demographic variables
Otherpsychosocial assessment and care
ProcedurePrimary outcomes
-
Number of treatment recommendations for depression made as measured by checklist of recommendations for depression treatment
Time frame: 2 years
-
Degree of patient satisfaction with interaction as measured by Medical Interview Satisfaction Scale
Time frame: 2 years
-
Overall patient experience as measured by Patient Experience Questionnaire
Time frame: 2 years
Secondary outcomes
-
Psychological and demographic subsets of patients
Time frame: 2 years
Sponsors and collaborators
Lead sponsor
Memorial Sloan Kettering Cancer Center
Other
Collaborators
- Lucille P. Markey Cancer Center at University of Kentucky
- National Cancer Institute (NCI)
- Vanderbilt University
Registry information
Official study title
Maximizing Utilization of Depression Screening in Lung Cancer Patients: A Randomized Trial
Important dates
- Study start
- 2006
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Nov 28, 2006
- Registry last updated
- May 1, 2013
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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