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.
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 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
Single group
Biospecimen Collection
Procedure/SurgeryUndergo blood sample collection
Dietary Intervention
Other interventionAttend High Fiber Program counseling sessions
Dietary Intervention
Other interventionAttend High Fiber Program weekly sessions
Dietary Intervention
Other interventionMake Fiber Aware Menu food selections
Dietary Intervention
Other interventionReceive study booklet
Questionnaire Administration
Other interventionAncillary studies
Percent of scheduled dietary counseling sessions attended and withdrawal status (Feasibility)
Feasibility in each patient will be assessed based on patient participating in ≥ 80% of scheduled dietary counseling sessions by the study dietitian and not withdrawing by day 60. Point estimates and corresponding 95% confidence intervals will be reported. Will be estimated with exact binomial 95% confidence intervals.
Highest daily fiber intake
Point estimates and corresponding 95% confidence intervals will be reported. Will be estimated with exact binomial confidence intervals. Distributions of baseline and day +60 intake will be summarized.
Longitudinal dietary fiber intake
Point estimates and corresponding 95% confidence intervals will be reported. Fiber intake trajectories will be analyzed using linear mixed-effects models with random intercepts for participants.
Number of types of plant-based fiber sources included in diet
Point estimates and corresponding 95% confidence intervals will be reported. The number and diversity of fiber sources will be summarized.
Duration that patients were not able to consume fiber
Point estimates and corresponding 95% confidence intervals will be reported. Will be analyzed using Kaplan-Meier methods. Median time and 95% confidence intervals will be reported.
Incidence of gastrointestinal toxicities and attribution to fiber intake
Point estimates and corresponding 95% confidence intervals will be reported. Assessed per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 6.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
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