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Clinical Trials/NCT00404365
NCT00404365CompletedNot Applicable

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

Memorial Sloan Kettering Cancer Center2 sites in 1 country241 target enrollmentStarted: April 1, 2006Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
241
Locations
2
Primary Endpoint
Degree of patient satisfaction with interaction as measured by Medical Interview Satisfaction Scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts 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

Exclusion Criteria

  • Not provided

Arms & Interventions

Arm I (control)

Experimental

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.

Intervention: counseling intervention (Other)

Arm I (control)

Experimental

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.

Intervention: screening questionnaire administration (Other)

Arm I (control)

Experimental

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.

Intervention: study of socioeconomic and demographic variables (Other)

Arm I (control)

Experimental

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.

Intervention: psychosocial assessment and care (Procedure)

Arm II

Experimental

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.

Intervention: counseling intervention (Other)

Arm II

Experimental

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.

Intervention: screening questionnaire administration (Other)

Arm II

Experimental

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.

Intervention: study of socioeconomic and demographic variables (Other)

Arm II

Experimental

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.

Intervention: psychosocial assessment and care (Procedure)

Arm III

Experimental

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.

Intervention: counseling intervention (Other)

Arm III

Experimental

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.

Intervention: screening questionnaire administration (Other)

Arm III

Experimental

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.

Intervention: study of socioeconomic and demographic variables (Other)

Arm III

Experimental

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.

Intervention: psychosocial assessment and care (Procedure)

Arm IV

Experimental

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.

Intervention: counseling intervention (Other)

Arm IV

Experimental

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.

Intervention: screening questionnaire administration (Other)

Arm IV

Experimental

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.

Intervention: study of socioeconomic and demographic variables (Other)

Arm IV

Experimental

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.

Intervention: psychosocial assessment and care (Procedure)

Outcomes

Primary Outcomes

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

Time Frame: 2 years

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

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(2 years)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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