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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-05448 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 20501 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium |
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| Name | Class |
|---|---|
| Swim Across America | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Supportive care (meal delivery service) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo blood and stool sample collection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Enrollment rate | 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. | Up to 1 year |
| Collection rate | Collection rate will be the percentage of stool samples, blood samples and surveys collected. | Up to 1 month post transplant |
| Tolerability of the delivered diet: Patient opinion | Patient opinion of the delivered meals will be assessed using qualitative end-study surveys. | Up to 1 month post transplant |
| Tolerability of the delivered diet: Proportion of meals consumed | 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. | Up to 1 month post transplant |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kate Markey | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42263665 | Derived | Ueland K, Elahi T, Rasmussen M, Wolfe AE, Purcell H, Chakka SR, Mirimo-Martinez M, Persinger H, Johnson K, Boynton AM, McMillen K, Byelykh M, Biernacki MA, Yeh AC, Ali N, Manjappa S, Wuliji N, Fredricks D, Bleakley M, Holmberg LA, Peled JU, Schenk J, Raftery D, Ma J, Hill GR, Neuhouser ML, Lee SJ, Markey KA. Plant-based whole-food diets are feasible during auto-HCT and are associated with dose-dependent microbiome modulation. Blood Adv. 2026 Jun 9:bloodadvances.2026020270. doi: 10.1182/bloodadvances.2026020270. Online ahead of print. | |
| 41674628 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 7, 2024 | Jul 31, 2025 |
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| Dietary Intervention | Other | Receive 3 meals per day and snacks |
|
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| Dietary Intervention | Other | Meet with dietitian |
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| Medical Chart Review | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| Derived |
| Ueland K, Elahi T, Rasmussen M, Wolfe AE, Purcell H, Chakka SR, Mirimo-Martinez M, Persinger H, Johnson K, Boynton A, McMillen K, Byelykh M, Biernacki MA, Yeh AC, Ali N, Manjappa S, Wuliji N, Fredricks DN, Bleakley M, Holmberg LA, Schenk JM, Raftery D, Ma J, Hill GR, Neuhouser ML, Lee SJ, Markey KA. Plant-based whole-food diets are feasible during autologous stem cell transplantation and are associated with dose-dependent microbiome modulation: Results from a pilot clinical trial. medRxiv [Preprint]. 2026 Feb 4:2026.02.02.26345403. doi: 10.64898/2026.02.02.26345403. |
| ICF_000.pdf |
| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D004035 | Diet Therapy |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D044623 | Nutrition Therapy |
| D013812 | Therapeutics |
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