Implementing a Plant-Based Whole-Foods Meal Delivery Service for Patients Undergoing Autologous Hematopoietic Cell Transplantation for Multiple Myeloma: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Tolerability of the delivered diet: Patient opinion
研究概览
简要总结
This clinical trial evaluates the impact of a plant-based whole-foods delivery service on the microbiome in patients with multiple myeloma undergoing an autologous hematopoietic cell transplant. An autologous hematopoietic cell transplant is a procedure in which blood-forming stem cells (cells from which all blood cells develop) are removed, stored, and later given back to the same person. Loss of microbial diversity within the intestinal tract has been associated with poor outcomes for patients receiving autologous stem cell transplantation. A plant-based whole meal delivery service may increase the intake of foods high in fiber and nutrients therefore improve microbial health during the peri-transplant period. In this pilot study, study investigators will explore the feasibility of this approach.
详细描述
OUTLINE:
Patients receive 3 meals per day and snacks delivered twice weekly and meet with dietitian once weekly on days -7 to 28. Patients undergo blood and stool sample collection on study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Able to provide written informed consent prior to initiation of any study procedures
- •Planned first autologous stem cell transplantation for multiple myeloma
- •Planned outpatient treatment for the duration of transplantation (if admitted, the investigators will request that caregivers bring the meals/snacks to the hospital as they might with other food prepared at home)
- •Access to a refrigerator
- •Ability to reheat foods
- •Able to consume an oral diet at enrollment
- •Able to communicate clearly regarding aspects of the study: e.g. Give feedback on logistics and meals, in order to maximize the operational data the investigators can gather in this pilot study
- •At least 18 years of age
排除标准
- •Major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach, as judged by the patient's medical team
- •Planned inpatient transplantation
结局指标
主要结局
Tolerability of the delivered diet: Patient opinion
时间窗: Up to 1 month post transplant
Patient opinion of the delivered meals will be assessed using qualitative end-study surveys.
Enrollment rate
时间窗: Up to 1 year
The proportion of eligible patients who consent to enroll in the study will be computed based on the number approached and estimated with 95% confidence intervals. Reasons for non-participation will be summarized.
Collection rate
时间窗: Up to 1 month post transplant
Collection rate will be the percentage of stool samples, blood samples and surveys collected.
Tolerability of the delivered diet: Proportion of meals consumed
时间窗: Up to 1 month post transplant
Patient acceptability of the delivered meals will be assessed using proportions of the delivered meals consumed based on multi-day food diaries and 24-hour recall assessments.
次要结局
未报告次要终点