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

NCT ID: NCT05842603Sponsor: Massachusetts General HospitalLast updated: 2025-09-25

Summary

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)

Detailed 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.

Arms & interventions

  • BehavioralCardiac Lifestyle Program

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

Outcome measures

Primary

  • Number of Participants that Complete at Least 9 Weeks of the 12 week Program

    Feasibility of this pilot trial will be measured by the number of participants that complete at least 9 weeks of the exercise program. This trial will be considered feasible if at least 70% (≥21) of participants complete the program. Completion rates will be measured with a 95% confidence interval for the adherence proportion calculated by exact binomial method.

    Time frame: Enrollment to end of the 3 month follow-up of last patient enrolled

Secondary

  • Change in MPN SAF-TSS Score from Baseline to Week 12

    Time frame: Baseline and Week 12 (end of program completion)

  • Change in FACIT-Fatigue Score from Baseline to Week 12

    Time frame: Baseline and Week 12 (end of program completion)

  • Change in HADS Score from Baseline to Week 12

    Time frame: Baseline and Week 12 (end of program completion)

  • Change in IPAQ Short Form Score from Baseline to Week 12

    Time frame: Baseline and Week 12 (end of program completion)

  • Changes in Healthy Eating Index (HEI) Score from Baseline to Week 12

    Time frame: Baseline and Week 12 (end of program completion)

  • Hematologic Response Rate

    Time frame: Baseline and Week 12 (end of program completion)

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (3)

Brigham and Women's Hospital

Boston, Massachusetts, 02215

Recruiting
Gabriela Hobbs, MD · Contact
617-724-1124ghobbs@partners.org

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

Not Yet Recruiting
Gabriela Hobbs, MD · Contact
617-724-1124ghobbs@partners.org

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, 02215

Recruiting
Gabriela Hobbs, MD · Contact
617-724-1124ghobbs@partners.org