NCT00951626已完成不适用
A Standardized Nursing Intervention Protocol for HCT Patients
City of Hope Medical Center1 个研究点 分布在 1 个国家目标入组 282 人开始时间: 2005年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 282
- 试验地点
- 1
- 主要终点
- Overall quality of life (physical, psychological, social, and spiritual well-being)
研究概览
简要总结
RATIONALE: Visiting patients at home to teach them about self care after a stem cell transplant may be more effective than standard therapy in improving quality of life.
PURPOSE: This clinical trial is studying home visits to see how well they work compared with standard therapy in treating patients undergoing donor stem cell transplant for hematologic cancer.
详细描述
OBJECTIVES:
Primary
- Test the effects of a Standardized Nursing Intervention Protocol (SNIP) on overall quality of life (QOL); physical, psychological, social, and spiritual well-being subscales; and functional status of patients undergoing allogeneic hematopoietic stem cell transplantation (AHSCT) at discharge, 3, 6, and 12 months post-hospitalization as compared to AHSCT patients who receive the usual care and attention control.
Secondary
- Test the effects of SNIP-AHSCT on time-to-first complication, total number of complications, and mortality across these groups of patients.
- Identify subgroups of patients who benefit most from the SNIP-AHSCT in relation to sociodemographic characteristics, disease and clinical factors, and transplant factors.
- Decompose the effect of the SNIP-AHSCT on QOL into direct and indirect effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
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 a hematologic cancer (e.g., leukemia or lymphoma)
- •Scheduled for a single allogeneic bone marrow or peripheral blood stem cell transplantation
- •PATIENT CHARACTERISTICS:
- •Living within a 50-mile radius of the City of Hope National Medical Center
- •English-speaking
- •PRIOR CONCURRENT THERAPY:
- •See Disease Characteristics
- •No prior hematopoietic stem cell transplantation
排除标准
- 未提供
结局指标
主要结局
Overall quality of life (physical, psychological, social, and spiritual well-being)
时间窗: Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline
Functional status
时间窗: Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline
次要结局
- Time-to-first complication(Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline)
- Total number of complications(Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline)
- Mortality(Baseline (discharge from hospital following Hematopoietic Cell Transplant) and 3, 6, and 12 months post baseline)
研究者
研究点 (1)
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