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临床试验/NCT00404365
NCT00404365已完成不适用

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

Memorial Sloan Kettering Cancer Center2 个研究点 分布在 1 个国家目标入组 241 人开始时间: 2006年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
241
试验地点
2
主要终点
Degree of patient satisfaction with interaction as measured by Medical Interview Satisfaction Scale

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: 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.

干预措施: psychosocial assessment and care (Procedure)

结局指标

主要结局

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

时间窗: 2 years

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

时间窗: 2 years

Overall patient experience as measured by Patient Experience Questionnaire

时间窗: 2 years

次要结局

  • Psychological and demographic subsets of patients(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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