Clinical trial NCT05842603: I Can Move with Purpose Now! a Pilot Lifestyle Intervention Study in Myeloproliferative Neoplasm Patients
Official title: I Can Move with Purpose Now! a Pilot Lifestyle Intervention Study in Myeloproliferative Neoplasm Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Myeloproliferative Disorders
Leukemia
Keywords: Myeloproliferative Disorders
Leukemia
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-05-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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)

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participants that Complete at Least 9 Weeks of the 12 week Program
timeFrame: Enrollment to end of the 3 month follow-up of last patient enrolled
Secondary outcomes:
measure: Change in MPN SAF-TSS Score from Baseline to Week 12
timeFrame: Baseline and Week 12 (end of program completion)
measure: Change in FACIT-Fatigue Score from Baseline to Week 12
timeFrame: Baseline and Week 12 (end of program completion)
measure: Change in HADS Score from Baseline to Week 12
timeFrame: Baseline and Week 12 (end of program completion)
measure: Change in IPAQ Short Form Score from Baseline to Week 12
timeFrame: Baseline and Week 12 (end of program completion)
measure: Changes in Healthy Eating Index (HEI) Score from Baseline to Week 12
timeFrame: Baseline and Week 12 (end of program completion)
measure: Hematologic Response Rate
timeFrame: Baseline and Week 12 (end of program completion)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital Cancer Center
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Gabriela Hobbs, MD
role: PRINCIPAL_INVESTIGATOR
References: