A program to help myeloproliferative neoplasm patients improve their lifestyle
I Can Move With Purpose Now! A Pilot Lifestyle Intervention Study in Myeloproliferative Neoplasm Patients
NA · Massachusetts General Hospital · NCT05842603
This study is testing a 12-week program that helps people with myeloproliferative neoplasms improve their nutrition and physical activity to see if it can lead to healthier living.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Massachusetts General Hospital (other) |
| Locations | 3 sites (Boston, Massachusetts and 2 other locations) |
| Trial ID | NCT05842603 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the feasibility of the Cardiac Lifestyle Program (CLP) for patients diagnosed with myeloproliferative neoplasms (MPNs). Over a 12-week period, participants will engage in tailored nutrition and physical activity interventions designed to promote healthier living. The study will involve screening for eligibility, in-clinic visits, questionnaires, group classes, and blood work to assess the program's effectiveness. Approximately 30 patients will be enrolled to determine if they can successfully complete the program.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older diagnosed with myeloproliferative neoplasms and having at least one cardiovascular risk factor.
Not a fit: Patients with intermediate or high-risk myelofibrosis or those without any cardiovascular risk factors may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could help improve the health and quality of life for patients with myeloproliferative disorders.
How similar studies have performed: While this approach is novel for myeloproliferative disorder patients, similar lifestyle interventions have shown success in other patient populations.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Boston, Massachusetts and 2 other locations
- Brigham and Women's Hospital — Boston, Massachusetts, United States (RECRUITING)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (NOT_YET_RECRUITING)
- Massachusetts General Hospital Cancer Center — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Gabriela Hobbs, MD — Massachusetts General Hospital
- Study coordinator: Gabriela Hobbs, MD
- Email: ghobbs@partners.org
- Phone: 617-724-1124
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Myeloproliferative Disorders, Leukemia