Remotely Administered Diet Intervention to Impact Symptom Burden in Myeloproliferative Neoplasm

Study Overview
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Brief Summary
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Myeloproliferative Neoplasm (MPN) is a chronic blood cancer without cure. The major clinical issues in MPN are 1) an increased risk of blood clots 2) symptoms thought to be driven by chronic inflammation which in some cases can be debilitating and 3) progression to acute leukemia. The current management of MPN focuses on preventing blood clots and relieving symptoms. However, treatments that reduce symptoms such as JAK inhibitors are limited to late stage MPN patients and have significant side effects including immunosuppression, reduction in platelets, and increased risk of skin cancer. Therefore, low risk interventions are sorely needed for MPN patients that can reduce symptoms. Diet represents a low risk way to reduce inflammation, specifically a Mediterranean diet has been found to reduce inflammation in cardiovascular disease. There has been a recently completed clinical trial that demonstrated MPN patients can adopt a Mediterranean diet if given dietician counseling and curriculum. However, in order to reach a larger group of people a fully remotely administered study is necessary. This is a feasibility study to determine.

Official Title
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A Randomized Clinical Trial to Assess the Impact of a Remotely Administered Diet Intervention on Symptom Burden and Inflammatory Cytokines in Myeloproliferative Neoplasm: Feasibility Phase

Conditions
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Myeloproliferative Neoplasm

Intervention / Treatment
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* Behavioral: Diet intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥18 with a diagnosis of a Philadelphia chromosome negative Myeloproliferative Neoplasm (MPN) including Essential Thrombocythemia (ET), Polycythemia Vera (PV), or Myelofibrosis (MF) Has access to the internet and email MPN-Total Symptom Score (MPN-TSS) score of ≥10 on screening survey Mediterranean Adherence score of ≤10 on screening survey English fluency (intervention requires conversations with study staff) In the opinion of the study team is amenable to changing one's diet Exclusion Criteria: Pregnant or planning to become pregnant over the course of the study Has food allergies, intolerances, or other dietary restrictions which would severely limit changes to their diet toward a Mediterranean style diet (such as allergies to ALL tree nuts or olive oil)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to either Mediterranean or Dietary Approaches to Stop Hypertension (DASH) diet
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mediterranean diet<br>Participants will be given dietician counseling on a Mediterranean diet | Behavioral: Diet intervention<br>* Participants will be given dietician counseling on their assigned diet<br>|
| Experimental: DASH diet<br>Participants will be given dietician counseling on a DASH diet | Behavioral: Diet intervention<br>* Participants will be given dietician counseling on their assigned diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MPN Symptom Assessment form (MPN-SAF) | validated survey tool to assess symptom burden in MPN | 16 weeks |