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


N/A
18 Years
N/A
Not Enrolling
Both
Depression, Lung Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Outcome Measure:

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

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

William Breitbart, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

Mskcc 06-038

NCT ID:

NCT00404365

Start Date:

April 2006

Completion Date:

April 2012

Related Keywords:

  • Depression
  • Lung Cancer
  • 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
  • Depression
  • Depressive Disorder
  • Lung Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer Center New York, New York  10021
Lucille P. Markey Cancer Center at University of Kentucky Lexington, Kentucky  40536-0093