I Can Move With Purpose Now! A Pilot Lifestyle Intervention Study in Myeloproliferative Neoplasm Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 6
- 主要终点
- Number of Participants that Complete at Least 9 Weeks of the 12 week Program
研究概览
简要总结
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)
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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.
排除标准
- •-- MF patients with intermediate-2 or high-risk disease by DIPSS
- •ECOG performance status >
- •Any injury or medical condition that would prohibit being able to safely perform exercise, as determined by the treating physician.
研究组 & 干预措施
Cardiac Lifestyle Program
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.
干预措施: Cardiac Lifestyle Program (Behavioral)
结局指标
主要结局
Number of Participants that Complete at Least 9 Weeks of the 12 week Program
时间窗: Enrollment to end of the 3 month follow-up of last patient enrolled
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.
次要结局
- Change in FACIT-Fatigue Score from Baseline to Week 12(Baseline and Week 12 (end of program completion))
- Change in HADS Score from Baseline to Week 12(Baseline and Week 12 (end of program completion))
- Change in IPAQ Short Form Score from Baseline to Week 12(Baseline and Week 12 (end of program completion))
- Hematologic Response Rate(Baseline and Week 12 (end of program completion))
- Change in MPN SAF-TSS Score from Baseline to Week 12(Baseline and Week 12 (end of program completion))
- Changes in Healthy Eating Index (HEI) Score from Baseline to Week 12(Baseline and Week 12 (end of program completion))
研究者
Gabriela Hobbs
Principal Investigator
Massachusetts General Hospital