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

Mass General Brigham

Status: Enrolling

Conditions: Myeloproliferative Disorders; Leukemia

Treatments: Behavioral: Cardiac Lifestyle Program

Study type: Interventional

Funder types: Other

Identifiers

NCT05842603

22-692

Details and patient eligibility

About

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)

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 1 patient group

Cardiac Lifestyle Program

Experimental group

Description:

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.

Treatment:

Behavioral: Cardiac Lifestyle Program