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Trial Title:
I Can Move With Purpose Now! A Pilot Lifestyle Intervention Study in Myeloproliferative Neoplasm Patients
NCT ID:
NCT05842603
Condition:
Myeloproliferative Disorders
Leukemia
Conditions: Official terms:
Neoplasms
Myeloproliferative Disorders
Conditions: Keywords:
Myeloproliferative Disorders
Leukemia
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Cardiac Lifestyle Program
Description:
12-week, tailored nutrition and physical activity program comprised of virtual and
in-person classes.
Arm group label:
Cardiac Lifestyle Program
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.
Criteria for 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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Brigham and Women's Hospital
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gabriela Hobbs, MD
Phone:
617-724-1124
Email:
ghobbs@partners.org
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Gabriela Hobbs, MD
Phone:
617-724-1124
Email:
ghobbs@partners.org
Facility:
Name:
Massachusetts General Hospital Cancer Center
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Gabriela Hobbs, MD
Phone:
617-724-1124
Email:
ghobbs@partners.org
Start date:
March 2024
Completion date:
January 1, 2025
Lead sponsor:
Agency:
Massachusetts General Hospital
Agency class:
Other
Source:
Massachusetts General Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05842603
