Pilot Study to Evaluate the Feasibility of High Fiber Program in Patients Undergoing Allogeneic Hematopoietic Cell Transplant (HCT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
研究概览
简要总结
This clinical trial studies whether the High Fiber Program can be used to increase fiber intake in patients undergoing allogeneic hematopoietic cell transplant (HCT). Allogeneic HCT is a procedure in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical, donor. This is often a sister or brother, but could be an unrelated donor. It is a potentially curative therapy for many conditions that affect the blood and blood-forming organs, but many patients must manage post-transplant complications, especially graft versus host disease (GVHD). GVHD occurs when the transplanted cells from a donor attack the body's normal cells causing skin rash or blisters, dry mouth, or dry eyes. The environment and health of the gut is important in allogeneic HCT patients, with an unhealthy gut environment and/or health leading to inflammation and possibly GVHD. Research has shown that diets high in fiber may improve the environment and health of the gut as well as outcomes following transplant; however, fiber intake remains low among patients. The High Fiber Program is a dietitian-led counseling program which teaches patients how to introduce high fiber foods into their diet and identify food choices and personalized strategies that will help them change their diet. The High Fiber Program may be an effective way to increase fiber intake in patients undergoing allogeneic HCT.
详细描述
PRIMARY OBJECTIVES:
I. To determine the feasibility of executing the High Fiber Program in HCT patients.
II. To estimate the proportion of patients who restore fiber intake to baseline levels by day 60 post-HCT.
SECONDARY OBJECTIVES:
I. To estimate the median number of days post-HCT when allogeneic HCT (alloHCT) patients achieve baseline fiber intake levels.
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
- •MAIN INCLUSION: Documented informed consent of the participant and/or legally authorized representative
- •MAIN INCLUSION: Age: ≥ 18 years
- •Patients ≥ 75 years of age that are otherwise eligible to undergo allogeneic HCT are included
- •MAIN INCLUSION: Karnofsky performance status ≥ 70%
- •MAIN INCLUSION: Within healthy BMI range 18-29 at the time of consent
- •MAIN INCLUSION: Ability to read and understand English for questionnaires
- •MAIN INCLUSION: Patients receiving myeloablative or reduced intensity conditioning regimens
- •MAIN INCLUSION: Adequate organ function consistent with institutional standards for HCT
- •MAIN INCLUSION: Patients must be scheduled to receive HCT within 45 days of consent
- •MAIN INCLUSION: Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (within 45 days prior to the start of conditioning)
- •If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required
- •MAIN INCLUSION: Agreement by females and males of childbearing potential to use an effective method of birth control or abstain from heterosexual activity for the course of the study through at least 6 months post-HCT
- •Childbearing potential defined as not being surgically sterilized (men and women) or have not been free from menses for > 1 year (women only)
排除标准
- •MAIN EXCLUSION: Clinically significant uncontrolled illness
- •MAIN EXCLUSION: Active infection requiring antibiotics
- •MAIN EXCLUSION: History of chronic gastrointestinal conditions such as inflammatory bowel disease or Crohn's disease
- •MAIN EXCLUSION: Medical contraindications to incorporating fiber in their diet as determined by the treating physician
- •MAIN EXCLUSION: Self-reported major dietary restrictions limiting fiber intake
- •MAIN EXCLUSION: Any other condition that would, in the investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
- •MAIN EXCLUSION: Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics)
研究组 & 干预措施
Supportive care (High Fiber Program)
Patients attend five or six High Fiber Program dietitian-lead counseling sessions up to 30 days and/or 18 days prior to scheduled HCT, upon admission to inpatient care, at discharge, at day 42 post-transplant (approximately 20-30 days post-discharge), and at day 60 post-transplant. Patients also meet with High Fiber Program dietitian QW and select food options from Fiber Aware Menu during admission. Additionally, patients receive a study booklet and undergo blood sample collection on study.
干预措施: Biospecimen Collection (Procedure)
Supportive care (High Fiber Program)
Patients attend five or six High Fiber Program dietitian-lead counseling sessions up to 30 days and/or 18 days prior to scheduled HCT, upon admission to inpatient care, at discharge, at day 42 post-transplant (approximately 20-30 days post-discharge), and at day 60 post-transplant. Patients also meet with High Fiber Program dietitian QW and select food options from Fiber Aware Menu during admission. Additionally, patients receive a study booklet and undergo blood sample collection on study.
干预措施: Dietary Intervention (Other)
Supportive care (High Fiber Program)
Patients attend five or six High Fiber Program dietitian-lead counseling sessions up to 30 days and/or 18 days prior to scheduled HCT, upon admission to inpatient care, at discharge, at day 42 post-transplant (approximately 20-30 days post-discharge), and at day 60 post-transplant. Patients also meet with High Fiber Program dietitian QW and select food options from Fiber Aware Menu during admission. Additionally, patients receive a study booklet and undergo blood sample collection on study.
干预措施: Questionnaire Administration (Other)