Lifestyle Intervention for Myeloproliferative Disorder

N/A

Recruiting

Led By Gabriela Hobbs, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up enrollment to end of the 3 month follow-up of last patient enrolled

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to see if CLP can help patients with myeloproliferative disorders become more active and eat healthier.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this intervention involves lifestyle changes like diet and exercise rather than medication, side effects may include muscle soreness from increased activity or changes in digestion due to dietary adjustments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ enrollment to end of the 3 month follow-up of last patient enrolled

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~enrollment to end of the 3 month follow-up of last patient enrolled

This trial's timeline: 3 weeks for screening, Varies for treatment, and enrollment to end of the 3 month follow-up of last patient enrolled for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Change in FACIT-Fatigue Score from Baseline to Week 12

Change in HADS Score from Baseline to Week 12

Change in IPAQ Short Form Score from Baseline to Week 12

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Cardiac Lifestyle ProgramExperimental Treatment1 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.

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