NCT00313573Unknown3 期
TeleCare Management of Pain and Depression in Cancer
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 480
- 试验地点
- 17
- 主要终点
- Compare efficacy of 3-component model telemedicine intervention to standard care in terms of depression and pain at baseline and 1, 3, 6, and 12 months
研究概览
简要总结
RATIONALE: Telemedicine may help in the treatment of depression and/or pain caused by cancer. It is not yet known whether telemedicine is more effective than standard care in treating depression and/or pain caused by cancer.
PURPOSE: This phase III randomized clinical trial is studying telemedicine to see how well it works compared to standard care in treating patients with depression and/or pain caused by cancer.
详细描述
OBJECTIVES:
Primary
- Compare the effectiveness of a state-wide, telemedicine intervention with standard care in cancer patients with clinical depression and/or cancer-related pain.
- Compare improvement in clinical depression and/or cancer-related pain in patients undergoing these interventions.
Secondary
- Compare health-related quality of life, functional status, and patient satisfaction with treatment in patients undergoing these interventions.
- Compare the economic benefits of these interventions in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
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 cancer AND 1 or both of the following:
- •Clinical depression
- •Depression must be of at least moderate severity (PHQ-9 score ≥ 10)
- •Depressed mood and/or anhedonia endorsed
- •No depression directly precipitated by cancer therapy for which depression is a well known side effect (e.g., interferon, corticosteroids)
- •Cancer-related pain
- •Pain must be at least moderate in severity (Brief Pain Inventory score ≥ 6), persisted despite using ≥ 2 analgesics, and cancer-related
- •If the only pain is due to a pre-existing condition (e.g., migraine, headache, arthritis, etc), the patient may not be eligible
- •PATIENT CHARACTERISTICS:
- •Life expectancy ≥ 6 months
- •Must speak English
- •Not pregnant
- •Fertile patients must use effective contraception
- •No moderately severe cognitive impairment
- •No schizophrenia or other psychosis
- •No disability claim currently being adjudicated for pain
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •Not in hospice care
排除标准
- 未提供
结局指标
主要结局
Compare efficacy of 3-component model telemedicine intervention to standard care in terms of depression and pain at baseline and 1, 3, 6, and 12 months
次要结局
- Health-related quality of life at baseline and 1, 3, 6, and 12 months
- Cost-effectiveness of care at baseline and 1, 3, 6, and 12 months
- Treatment satisfaction at baseline and 1, 3, 6, and 12 months
研究者
研究点 (17)
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