跳至主要内容
临床试验/NCT00951184
NCT00951184已完成不适用

Efficiency of Screening for Depression in Cancer Patients Receiving Radiotherapy

Radiation Therapy Oncology Group16 个研究点 分布在 1 个国家目标入组 463 人开始时间: 2009年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
463
试验地点
16
主要终点
Feasibility of a screening procedure for major depression

研究概览

简要总结

RATIONALE: Gathering information about depression in patients with cancer may help doctors learn more about the disease and plan the best treatment.

PURPOSE: This clinical trial is studying depression screening in patients undergoing radiation therapy for cancer.

详细描述

OBJECTIVES:

Primary

  • Assess the feasibility of a screening procedure for major depression in cancer patients undergoing definitive or palliative radiotherapy.

Secondary

  • Establish the rates of major depression identified through diagnostic telephone interviews.
  • Estimate the false negative rate (1-sensitivity) and false positive rate (1-specificity) of the 9-item Patient Health Questionnaire (PHQ-9) and the 25-item Hopkins Symptom Checklist (HSCL-25).
  • Compare the false negative rate of 2 items addressing mood disturbance on the PHQ-9 relative to all 9-items on the PHQ-9 and to the HSCL-25.
  • Examine the sensitivity to changes in depression severity of the PHQ-9, the HSCL-25, and the Structured Clinical Interview for DSM-IV (SCID) .
  • Correlate both depressive symptoms and major depression in terms of sociodemographic and clinical variables.
  • Establish the nature and adequacy of existing care, patient preferences, treatment availability, and barriers to depression treatment utilization for patients identified with major depression using the Assessment of Mental Health Services and Barriers to Care.
  • Assess rates of continued elevations of depressive symptoms, seeking and receipt of care, and barriers to care at follow-up in these patients.
  • Examine the differences in study objectives based on institution characteristics with regard to existing psychosocial services that are provided on-site and integrated in cancer care.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Feasibility of a screening procedure for major depression

时间窗: Within 1 week of registration

次要结局

  • Symptoms, seeking and receipt of care, and barriers to care at 3-month follow-up(Within 4 weeks of registration)
  • False negative rate and false positive rate of the 9-item Patient Health Questionnaire (PHQ-9) and the 25-item Hopkins Symptom Checklist (HSCL-25)(Within 4 weeks of registration)
  • Sociodemographic and clinical correlates with depressive symptoms and major depression(Within 4 weeks of registration)
  • Rates of major depression as identified in diagnostic telephone interviews(Within 4 weeks of registration)
  • Sensitivity to changes in depression severity of the PHQ-9, the HSCL-25, and the Structured Clinical Interview for DSM-IV (SCID)(Within 4 weeks of registration)
  • Patient preferences, existing care, treatment availability, and barriers to its utilization determined at the diagnostic interview(Within 4 weeks of registration)
  • Differences in study endpoints based on institution characteristics with regard to existing psychosocial services that are provided on-site and integrated in cancer care(Within 1 week of registration)
  • False negative rate of 2 items addressing mood disturbance on the PHQ-9 relative to all 9-items on the PHQ-9 and to the HSCL-25(Within 4 weeks of registration)

研究者

申办方类型
Network
责任方
Sponsor

研究点 (16)

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