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Behavioral Intervention
Lifestyle Intervention for Myeloproliferative Disorder
N/A
Recruiting
Led By Gabriela Hobbs, MD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment to end of the 3 month follow-up of last patient enrolled
Awards & highlights
Study Summary
This trial aims to see if CLP can help patients with myeloproliferative disorders become more active and eat healthier.
Who is the study for?
This trial is for adults over 18 with myeloproliferative disorders (like ET, PV, pre-MF, MF, or MPN-NOS) who are low to intermediate-1 risk. They should be fairly active (ECOG status 0-1) and have at least one cardiovascular risk factor such as being overweight or having high blood pressure, cholesterol issues, diabetes/pre-diabetes/metabolic syndrome, or a history of heart disease.Check my eligibility
What is being tested?
The study tests the Cardiac Lifestyle Program (CLP), which lasts for 12 weeks and focuses on helping patients become more physically active and eat healthier. The program is tailored to each individual's needs.See study design
What are the potential side effects?
Since this intervention involves lifestyle changes like diet and exercise rather than medication, side effects may include muscle soreness from increased activity or changes in digestion due to dietary adjustments.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ enrollment to end of the 3 month follow-up of last patient enrolled
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment to end of the 3 month follow-up of last patient enrolled
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants that Complete at Least 9 Weeks of the 12 week Program
Secondary outcome measures
Change in FACIT-Fatigue Score from Baseline to Week 12
Change in HADS Score from Baseline to Week 12
Change in IPAQ Short Form Score from Baseline to Week 12
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Cardiac Lifestyle ProgramExperimental Treatment1 Intervention
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.
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,935 Previous Clinical Trials
13,198,611 Total Patients Enrolled
Gabriela Hobbs, MDPrincipal InvestigatorMassachusetts General Hospital
4 Previous Clinical Trials
130 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My myelofibrosis is classified as intermediate-2 or high-risk.I have been diagnosed with a specific blood disorder according to WHO 2016 criteria.I have a cardiovascular risk such as high BMI, high blood pressure, high cholesterol, diabetes, or a history of heart disease.I am fully active or can carry out light work.I need assistance with my daily activities due to my health condition.
Research Study Groups:
This trial has the following groups:- Group 1: Cardiac Lifestyle Program
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any current openings for those wishing to participate in this trial?
"Unfortunately, according to clinicaltrials.gov this trial is not presently accepting participants. The study was initially posted on October 1st 2023 and recently updated on May 1st 2023. Even though it has stopped enrolling patients for now, there are 3,877 other investigations inviting volunteers at the moment."
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