Multiple Myeloma
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREBiospecimen Collection
Undergo blood and stool sample collection
OTHERDietary Intervention
Receive 3 meals per day and snacks
OTHERMedical Chart Review
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
Swim Across America
Fred Hutchinson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment rate | 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 | 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: Patient opinion | Up to 1 month post transplant | Patient opinion of the delivered meals will be assessed using qualitative end-study surveys. |
| Tolerability of the delivered diet: Proportion of meals consumed | 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. |
Countries
United States
Outcome results
None listed