NCT03667599招募中不适用
A Randomized Phase 2 Study of Home Care Following Autologous Hematopoietic Stem Cell Transplantation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Quality of Life in Caregivers (Caregiver Strain Index)
研究概览
简要总结
This is a research study to compare the well-being (caregiver strain index) of caregivers of patients receiving home vs standard care after autologous hematopoietic stem cell transplant.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Scheduled to undergo an autologous hematopoietic stem cell transplant for any cancer or non-cancer illness
- •Age 18-80 years
- •Karnofsky Performance Scale KPS> 80
- •Able to read/write English
- •A home that is deemed, upon inspection, in suitable condition to serve as a medical home, within a 90-minute driving distance of Duke
排除标准
- •Lack of a caregiver
- •Pregnant women
- •Patients with a documented active infection prior to starting their preparative regimen. This includes grade 3 or higher viral, bacterial, or fungal infection.
- •Use of homeopathic medications, prebiotics, or probiotics that may impact gut microbiota
- •Caregiver Inclusion Criteria:
- •Identified by patient as their primary caregiver
- •Meet standard clinical criteria for being a caregiver (able to drive and take care of patient)
- •Age 18-80 years
- •Caregiver Exclusion Criteria:
结局指标
主要结局
Quality of Life in Caregivers (Caregiver Strain Index)
时间窗: 14 days
To compare the quality of life (Caregiver Strain Index) in caregivers of patients receiving home vs standard care after autologous hematopoietic stem cell transplant.
次要结局
- Rates of Overall Infections(1 year)
- Rates of Fungal Infections(1 year)
- Measuring Caregiver Quality of Life as assessed by the FACT-GP(1 year)
- Measuring Caregiver Fatigue as assessed by the PROMIS-Fatigue(1 year)
- Measuring Caregiver Mental Health as assessed by the PROMIS-Anxiety(1 year)
- Measuring Caregiver Burden as recorded in a Time Diary(1 year)
- Measuring Caregiver Self-Efficacy assessed by the Modified Lorig(1 year)
- Measuring Caregiver Satisfaction assessed by Caregiver Satisfaction(1 year)
- Measuring Caregiver Quality of Life as assessed by the PROMIS-Global Health(1 year)
- Measuring Return to Work in Caregivers (Work Assessment)(1 year)
- Disease Free Survival(1 year)
- Rates of Viral Infections(1 year)
- Rates of Hospital Admission(1 year)
- Transplant Length of Stay(1 year)
- Measuring Caregiver Mental Health as assessed by the PROMIS-Depression(1 year)
- Overall Survival(1 year)
- Measuring Quality of Life as assessed by the EQ-5D-5L(1 year)
- Measuring Mental Health as assessed by the PROMIS-Anxiety(1 year)
- Measuring Mental Health as assessed by the PROMIS-Depression(1 year)
- Measuring Caregiver Fatigue as assessed by the PROMIS-Sleep(1 year)
- Measuring Return to Work as assessed by the Work Assessment(1 year)
- Measuring Nutrition as assessed by the PG-SGA(30 days)
- Rates of Bacterial Infections(1 year)
- Measuring Self-Efficacy as assessed by the Lorig(1 year)
- Measuring Out-of-Pocket Costs as recorded in a Cost Diary(1 year)
- Measuring Exercise as assessed by 6 minute walk test(1 year)
- Measuring Changes in fecal samples as measured by 16s rRNA sequencing(1 year)
- Measuring adverse events as per National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE)(1 year)
- Measuring Indirect Costs (Patient's and Caregivers' Time)(1 year)
- Measuring Symptoms as assessed by MDASI scale(1 year)
- Measuring Fatigue as assessed by the PROMIS-Sleep(1 year)
- Measuring Social Support as assessed by the PROMIS-Social Isolation(1 year)
- Measuring Hand Grip Strength(1 year)
- Measuring Changes in the skin flora (microbiome)(1 year)
- Measuring Direct Medical Costs(6 months)
- Measuring Fatigue as assessed by the PROMIS-Fatigue(1 year)
- Measuring treatment related mortality (TRM)(1 year)
- Measuring Health Resource Utilization using Duke University Health System (DUHS) records(1 year)
研究者
研究点 (2)
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