Recruiting

Lifestyle Intervention

Sponsor:

Massachusetts General Hospital

Code:

NCT05842603

Conditions

Myeloproliferative Disorders

Leukemia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cardiac Lifestyle Program

Study Details

Brief 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)

Conditions

Myeloproliferative Disorders

Leukemia

Study ID

NCT05842603

Start date

Mar 1, 2024

Status verified date

Sep, 2025

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

Cardiac Lifestyle Program

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

Primary outcome measure

  • Number of Participants that Complete at Least 9 Weeks of the 12 week Program [ Time Frame: Enrollment to end of the 3 month follow-up of last patient enrolled ]

Central Contacts and Locations

Central contacts

Gabriela Hobbs, MD

617-724-1124ghobbs@partners.org

Gabriella Hobbs, MD

617-724-1124ghobbs@partners.org

Locations

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Gabriela Hobbs, MD

617-724-1124ghobbs@partners.org

Massachusetts General Hospital Cancer Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Gabriela Hobbs, MD

617-724-1124ghobbs@partners.org

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Sep 25, 2025

Last verified

Sep, 2025

Keywords

  • Myeloproliferative Disorders
  • Leukemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-09-25.