I Can Move With Purpose Now! A Pilot Lifestyle Intervention Study in Myeloproliferative Neoplasm Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-01

Study Completion Date

2027-01-01

Brief Summary

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The goal of this study is to see if patients with myeloproliferative disorders are able to successfully complete the Cardiac Lifestyle Program(CLP). The goal of the CLP is to teach patients how to become more active and eat healthier foods.

The name of the intervention used in this research study is:

Cardiac Lifestyle Program (a 12-week, tailored nutrition and physical activity program)

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Detailed Description

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This is a single-arm, prospective pilot study that will enroll eligible Myeloproliferative Neoplasms (MPN) patients in a 12-week exercise and nutrition-based Cardiac Lifestyle Program (CLP). This research study is a Feasibility Study, which is the first time investigators are examining this exercise program in myeloproliferative disorder patients.

Study procedures include screening for eligibility, an in-clinic visit, questionnaires, program group classes, and blood work.

Participation in this research study is expected to last 12 weeks.

It is expected that about 30 people will take part in this research study.

Conditions

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Myeloproliferative Disorders Leukemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Cardiac Lifestyle Program

Participants will complete study procedures as follows:

* Baseline in-clinic visit with research team doctor for history and physical and the completion of questionnaires.
* 6 virtual group classes alternating with 6 in-person group classes.
* Semi-structured exit interview.

Group Type EXPERIMENTAL

Cardiac Lifestyle Program

Intervention Type BEHAVIORAL

12-week, tailored nutrition and physical activity program comprised of virtual and in-person classes.

Interventions

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Cardiac Lifestyle Program

12-week, tailored nutrition and physical activity program comprised of virtual and in-person classes.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

-≥18 years of age

* Diagnosed with an MPN by WHO 2016 criteria,22 including essential thrombocythemia (ET), polycythemia vera (PV), prefibrotic myelofibrosis (pre-MF), myelofibrosis (MF), and MPN not otherwise specified (NOS). Within MF patients, only patients who are low or intermediate-1 risk by the Dynamic International Prognostic Scoring System (DIPSS) are eligible.23 All risk groups are eligible for the remaining MPN subtypes.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Must have at least one cardiovascular risk factor including: Body mass index (BMI) \>25 kg/m2, hypertension, hyperlipidemia, diabetes mellitus or pre-diabetes or metabolic syndrome, or any prior history of cardiovascular disease, transient ischemic attack, stroke, or peripheral vascular disease. Patients not meeting any cardiovascular risk criteria must receive prior approval from the PI to participate in this study.

Exclusion Criteria

\-- MF patients with intermediate-2 or high-risk disease by DIPSS

* ECOG performance status \>2.
* Any injury or medical condition that would prohibit being able to safely perform exercise, as determined by the treating physician.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No