NCT03449927已完成1 期
A Pilot Study of Implementation of a Nutritional Tool During Melphalan Autologous Transplant to Improve Caloric and Protein Intake
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Pre and post intervention mean total caloric intake
研究概览
简要总结
The purpose of this pilot before and after interventional study is to determine if early intervention and provision of menus regarding appropriate diet choices for melphalan autologous transplant patients experiencing nausea and diarrhea will improve nutrition status and overall calorie and protein intake throughout the transplant process.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 undergoing melphalan autologous transplants will be included in this study
- •All patients that will be included in this pilot before and after interventional study will be inpatient on floors 5900, 6900 or 8900 of Barnes-Jewish Hospital
- •Per hospital protocol, all patients who will receive a melphalan autologous transplant will be admitted and remain inpatient for the duration of the transplant process. There will be no exclusion for dietary restrictions or food allergies as the foodservice provided to patients is room service, all food allergies are noted and suitable alternatives are provided as a standard of service.
- •Once a patient has been determined to meet criteria for the study, they will be approached by a member of the research team between day -2 and day 0 of transplant for consent. Patients must consent for the study by day +1 of transplant to be enrolled.
排除标准
- •Patients <18 years of age
- •Pregnant women
- •Prisoners
- •Patient unable to provide informed consent.
研究组 & 干预措施
Control Arm: Regular menu
Active Comparator
- Calorie count initiated on day +1 of transplant and ending upon count recovery
- Symptom worksheet initiated on day +1 of transplant and ending upon count recovery (absolute neutrophil count of 1000)
- Goals to monitor: calorie and protein intake, self-reported diarrhea and nausea
- Interventions provided for control group: standard of care, verbal or printed handouts, standard educations created by Barnes Jewish Hospital (BJH) oncology dietitians
干预措施: Standard of care menu (Other)
Control Arm: Regular menu
Active Comparator
- Calorie count initiated on day +1 of transplant and ending upon count recovery
- Symptom worksheet initiated on day +1 of transplant and ending upon count recovery (absolute neutrophil count of 1000)
- Goals to monitor: calorie and protein intake, self-reported diarrhea and nausea
- Interventions provided for control group: standard of care, verbal or printed handouts, standard educations created by Barnes Jewish Hospital (BJH) oncology dietitians
干预措施: Self report dietary intake worksheet (Other)
Control Arm: Regular menu
Active Comparator
- Calorie count initiated on day +1 of transplant and ending upon count recovery
- Symptom worksheet initiated on day +1 of transplant and ending upon count recovery (absolute neutrophil count of 1000)
- Goals to monitor: calorie and protein intake, self-reported diarrhea and nausea
- Interventions provided for control group: standard of care, verbal or printed handouts, standard educations created by Barnes Jewish Hospital (BJH) oncology dietitians
干预措施: Post study questionnaire (Other)
Intervention Arm: Specialized Menu
Experimental
- Calorie count and tool provided on day +1 and ending upon count recovery
- Symptom worksheet initiated on day +1 of transplant and ending upon count recovery (absolute neutrophil count of 1000)
- Goals to monitor: calorie and protein intake, self-reported diarrhea and nausea
- Interventions provided for intervention group: standard of care provided by BJH oncology dietitians, tools including nausea and diarrhea menus and follow up by registered dietitian (RD) to provide additional counseling on menus as symptoms arise
干预措施: Specialized menu (Other)
Intervention Arm: Specialized Menu
Experimental
- Calorie count and tool provided on day +1 and ending upon count recovery
- Symptom worksheet initiated on day +1 of transplant and ending upon count recovery (absolute neutrophil count of 1000)
- Goals to monitor: calorie and protein intake, self-reported diarrhea and nausea
- Interventions provided for intervention group: standard of care provided by BJH oncology dietitians, tools including nausea and diarrhea menus and follow up by registered dietitian (RD) to provide additional counseling on menus as symptoms arise
干预措施: Self report dietary intake worksheet (Other)
Intervention Arm: Specialized Menu
Experimental
- Calorie count and tool provided on day +1 and ending upon count recovery
- Symptom worksheet initiated on day +1 of transplant and ending upon count recovery (absolute neutrophil count of 1000)
- Goals to monitor: calorie and protein intake, self-reported diarrhea and nausea
- Interventions provided for intervention group: standard of care provided by BJH oncology dietitians, tools including nausea and diarrhea menus and follow up by registered dietitian (RD) to provide additional counseling on menus as symptoms arise
干预措施: Post study questionnaire (Other)
结局指标
主要结局
Pre and post intervention mean total caloric intake
时间窗: Through count recovery (10 days)
Mean total protein intake
时间窗: Through count recovery (10 days)
次要结局
- Mean daily caloric intake(Through count recovery (10 days))
- Mean daily protein intake(Through count recovery (10 days))
研究者
研究点 (2)
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