NCT00709176已完成不适用
Outcomes of Triaged Family Care in Advanced Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 484
- 试验地点
- 10
- 主要终点
- Change in Quality of Life
研究概览
简要总结
The purpose of this study is to assess the quality of life of patients with advanced cancer and their family caregivers and to evaluate two doses of a family-based program of care versus control.
详细描述
The purpose of this study is to:
- determine if family dyads randomly assigned to either a brief or extensive family-based program of care have better proximal and distal outcomes from both a clinical and economic perspective than dyads randomly assigned to usual care
- determine if the brief or extensive program of care has a differential effect on patient and caregiver outcomes depending on the patient's baseline risk for distress status (high versus low).
A longitudinal, randomized clinical trial is being used for patients with advanced lung, colorectal, prostate, and breast cancer and their caregivers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Patients with Stage 3 or 4 breast, prostate, colorectal and lung cancers.
- •Patients must be 21 years old or older, physically and mentally able to participate, speak and understand English, have a minimum life expectancy of six months, live within 75 miles of one of the participating sites and have a family caregiver who is willing to participate in the study.
- •For this study "family caregiver" is defined as the person who provides the patient with physical and/or emotional support during cancer treatment.
- •Family caregivers must be 18 years old or older, physically and mentally able to participate, and speak and understand English.
排除标准
- •Patients will be excluded if they have multiple primary cancer sites.
- •Family caregivers will be excluded if they, themselves, have been diagnosed with cancer during the previous year and/or are in active treatment for cancer.
结局指标
主要结局
Change in Quality of Life
时间窗: Baseline, 3 and 6 months
次要结局
- Change in Health Care Resource Utilization(Baseline, 3 and 6 months)
- Change in Caregiver Burden(Baseline, 3 and 6 months)
- Change in Emotional Distress(Baseline, 3 and 6 months)
- Change in Uncertainty(Baseline, 3 and 6 months)
- Change in Hopelessness(Baseline, 3 and 6 months)
- Change in Benefits of Illness(Baseline, 3 and 6 months)
- Change in Depression(Baseline, 3 and 6 months)
- Risk for Distress(Baseline)
- Change in Coping(Baseline, 3 and 6 months)
- Change in Appraisal of Illness/Caregiving(Baseline, 3 and 6 months)
- Change in Self-efficacy(Baseline, 3 and 6 months)
- Change in Family Communication(Baseline, 3 and 6 months)
- Change in Support(Baseline, 3 and 6 months)
研究者
研究点 (10)
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