Lifestyle Intervention for Myeloproliferative Disorder

Recruiting at 2 trial locations

Overseen By Gabriella Hobbs, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Intermediate-2/high-risk MF, ECOG >2, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 12 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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)

Research Team

Gabriela Hobbs, MD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults over 18 with myeloproliferative disorders (like ET, PV, pre-MF, MF, or MPN-NOS) who are low to intermediate-1 risk. They should be fairly active (ECOG status 0-1) and have at least one cardiovascular risk factor such as being overweight or having high blood pressure, cholesterol issues, diabetes/pre-diabetes/metabolic syndrome, or a history of heart disease.

Inclusion Criteria

I have been diagnosed with a specific blood disorder according to WHO 2016 criteria.

I have a cardiovascular risk such as high BMI, high blood pressure, high cholesterol, diabetes, or a history of heart disease.

I am fully active or can carry out light work.

Exclusion Criteria

Any injury or medical condition that would prohibit being able to safely perform exercise, as determined by the treating physician.

My myelofibrosis is classified as intermediate-2 or high-risk.

I need assistance with my daily activities due to my health condition.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants engage in a 12-week Cardiac Lifestyle Program involving exercise and nutrition

12 weeks

6 virtual group classes, 6 in-person group classes

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Cardiac Lifestyle Program

Trial Overview The study tests the Cardiac Lifestyle Program (CLP), which lasts for 12 weeks and focuses on helping patients become more physically active and eat healthier. The program is tailored to each individual's needs.

Participant Groups

Group I: Cardiac Lifestyle Program Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+