A Plant-Based Whole-Foods Meal Delivery Service for Patients With Multiple Myeloma Undergoing Autologous Hematopoietic Cell Transplant

Not Applicable

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Procedure: Biospecimen Collection; Other: Dietary Intervention; Other: Medical Chart Review; Other: Questionnaire Administration

• Registration Number: NCT06559709
• Lead Sponsor: Fred Hutchinson Cancer Center

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 late...

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2024-07-15
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-16
• Study First Posted: 2024-08-19
• Study Start: 2024-10-14
• Last Update Submitted: 2024-10-21
• Last Update Posted: 2024-10-23
• Primary Completion: 2025-06-25
• Study Completion: 2025-06-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (meal delivery service)	Biospecimen Collection	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.
Supportive care (meal delivery service)	Dietary Intervention	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.
Supportive care (meal delivery service)	Questionnaire Administration	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.
Supportive care (meal delivery service)	Medical Chart Review	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.

Primary Outcome Measures

Name	Time	Method
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.
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: 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.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States