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

Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05842603
• Other study ID #: 22-692
• Status: Recruiting
• Phase: N/A
• Start date: March 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: Gabriela Hobbs, MD
• Phone: 617-724-1124
• Email: ghobbs[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 1, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Leukemia
• Myeloproliferative Disorders
• Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Enrollment to end of the 3 month follow-up of last patient enrolled
Secondary	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.	Baseline and Week 12 (end of program completion)
Secondary	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.	Baseline and Week 12 (end of program completion)
Secondary	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.	Baseline and Week 12 (end of program completion)
Secondary	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.	Baseline and Week 12 (end of program completion)
Secondary	Changes in Healthy Eating Index (HEI) Score from Baseline to Week 12	The Automated Self-Administered Dietary Assessment Tool (ASA24), a free web-based 24-hour dietary recall tool developed by the National Cancer Institute. Responses will be used to calculate a Healthy Eating Index (HEI) score, which is based on density values/ratios of intake per total energy. The HEI is a measure of dietary quality that addresses compliance with the 2015 USDA dietary guidelines. Change = Week 12 scores - Baseline scores.	Baseline and Week 12 (end of program completion)
Secondary	Hematologic Response Rate	Hematologic response rates are defined by International Working Group (IWG) working criteria including proportion of patients achieving all of the following: platelet count = 400 x 109/L, WBC count <10 x 109/L, and absence of leukoerythroblastosis, hematocrit <45%.	Baseline and Week 12 (end of program completion)