I Can Move With Purpose Now! A Pilot Lifestyle Intervention Study in Myeloproliferative Neoplasm Patients

Обзор

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)

Подробное описание

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.

Вмешательства

• Поведенческое Cardiac Lifestyle Program
  12-week, tailored nutrition and physical activity program comprised of virtual and in-person classes.

Первичные конечные точки

• Number of Participants that Complete at Least 9 Weeks of the 12 week Program [Срок оценки: Enrollment to end of the 3 month follow-up of last patient enrolled]

Вторичные конечные точки (6)

• Change in MPN SAF-TSS Score from Baseline to Week 12 [Срок оценки: Baseline and Week 12 (end of program completion)]
• Change in FACIT-Fatigue Score from Baseline to Week 12 [Срок оценки: Baseline and Week 12 (end of program completion)]
• Change in HADS Score from Baseline to Week 12 [Срок оценки: Baseline and Week 12 (end of program completion)]
• Change in IPAQ Short Form Score from Baseline to Week 12 [Срок оценки: Baseline and Week 12 (end of program completion)]
• Changes in Healthy Eating Index (HEI) Score from Baseline to Week 12 [Срок оценки: Baseline and Week 12 (end of program completion)]
• Hematologic Response Rate [Срок оценки: Baseline and Week 12 (end of program completion)]

Критерии участия

Критерии включения

-≥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.

Критерии исключения

\-- 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 3 центра

• Brigham and Women's Hospital — Boston
• Dana-Farber Cancer Institute — Boston
• Massachusetts General Hospital Cancer Center — Boston

Идентификаторы

NCT: NCT05842603 · 22-692

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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