Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05842603 | RECRUITING | Myeloproliferative Disorders

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

Massachusetts General Hospital

Information provided by (Responsible Party):

Gabriela Hobbs

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)

Condition or disease

Myeloproliferative Disorders

Leukemia

Intervention/treatment

Cardiac Lifestyle Program

Phase

NA

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.

Study Type : INTERVENTIONAL
Estimated Enrollment : 30 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : I Can Move With Purpose Now! A Pilot Lifestyle Intervention Study in Myeloproliferative Neoplasm Patients
Actual Study Start Date : 2024-03-01
Estimated Primary Completion Date : 2027-01-01
Estimated Study Completion Date : 2027-01-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
I Can Move With Purpose Now! A Pilot Lifestyle Intervention Study in Myeloproliferative Neoplasm Patients

Location Details

NCT05842603

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Massachusetts

Brigham and Women's Hospital

Boston, Massachusetts, United States, 02215

NOT YET RECRUITING

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215

RECRUITING

United States, Massachusetts

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States, 02215