NCT00951184已完成不适用
Efficiency of Screening for Depression in Cancer Patients Receiving Radiotherapy
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
- 否
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
研究点 (16)
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