I Can Move With Purpose Now! A Pilot Lifestyle Intervention Study in Myeloproliferative Neoplasm Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About 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)
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
ECOG performance status >2.
Any injury or medical condition that would prohibit being able to safely perform exercise, as determined by the treating physician.
Trial design
Design model
Single group
Treatments tested in this trial
Cardiac Lifestyle Program
Behavioral12-week, tailored nutrition and physical activity program comprised of virtual and in-person classes.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Cardiac Lifestyle ProgramExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of Participants that Complete at Least 9 Weeks of the 12 week Program
Feasibility of this pilot trial will be measured by the number of participants that complete at least 9 weeks of the exercise program. This trial will be considered feasible if at least 70% (≥21) of participants complete the program. Completion rates will be measured with a 95% confidence interval for the adherence proportion calculated by exact binomial method.
Time frame
Enrollment to end of the 3 month follow-up of last patient enrolledSecondary outcomes
1
Change in MPN SAF-TSS Score from Baseline to Week 12
The MPN-SAF TSS is a validated 10-item symptom assessment form that captures the most common symptoms affecting MPN patients, and is considered a standard assessment in clinical trials evaluating interventions in MPN patients. Possible scores range from 0 to 100. Change = Week 12 Score - Baseline Score.
Time frame
Baseline and Week 12 (end of program completion)2
Change in FACIT-Fatigue Score from Baseline to Week 12
The FACIT-F is a 41-item questionnaire consisting of the FACT-G (28 items), which measures health-related quality of life covering four domains of well-being (physical, social/family, emotional, functional), plus 13 fatigue-specific items. Possible scores range from 0 to 164. Change = Week 12 Score - Baseline Score.
Time frame
Baseline and Week 12 (end of program completion)3
Change in HADS Score from Baseline to Week 12
The Hospital Anxiety and Depression Scale (HADS) is a 14-item self-report measure of depressive and anxiety symptoms specifically designed for use with medical patients. Possible scores range from 0-42. Change = Week 12 Score - Baseline Score.
Time frame
Baseline and Week 12 (end of program completion)4
Change in IPAQ Short Form Score from Baseline to Week 12
The IPAQ Short Form is a 7-item questionnaire that measures the amount and time spent doing various levels of physical activity over the last week. Participant answers are based on number of minutes, hours, or days spent on performing activities of various intensities. Change = Week 12 scores on each item - Baseline scores on each item.
Time frame
Baseline and Week 12 (end of program completion)Sponsors and contacts
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Source ClinicalTrials.gov