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Completed

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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Key information

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

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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

counseling intervention

Other

screening questionnaire administration

Other

study of socioeconomic and demographic variables

Other

psychosocial assessment and care

Procedure

Primary outcomes

  1. Number of treatment recommendations for depression made as measured by checklist of recommendations for depression treatment

    Time frame: 2 years

  2. Degree of patient satisfaction with interaction as measured by Medical Interview Satisfaction Scale

    Time frame: 2 years

  3. Overall patient experience as measured by Patient Experience Questionnaire

    Time frame: 2 years

Secondary outcomes

  1. 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.

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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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