Myeloproliferative DisordersNCT05842603
I Can Move With Purpose Now! A Pilot Lifestyle Intervention Study in Myeloproliferative Neoplasm Patients
A study testing Cardiac Lifestyle Program in people with Myeloproliferative Disorders and Leukemia, run by Massachusetts General Hospital at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Disorders, Leukemia
- What is being tested?
- Cardiac Lifestyle Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Mar 2024to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- -≥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.
Who cannot join
- -- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites, 3 recruiting
- Recruiting
Brigham and Women's Hospital
Boston, Massachusetts, 02215
Gabriela Hobbs, MD, 617-724-1124, ghobbs@partners.org
- Not yet recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Gabriela Hobbs, MD, 617-724-1124, ghobbs@partners.org
- Recruiting
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02215
Gabriela Hobbs, MD, 617-724-1124, ghobbs@partners.org
About this study
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)
Read the detailed 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.
- Conditions
- Myeloproliferative Disorders, Leukemia
- Being tested
- Cardiac Lifestyle Program
- Keywords
- Myeloproliferative Disorders, Leukemia
- Medical subject headings
- Myeloproliferative Disorders, Leukemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Lifestyle ProgramBehavioural
12-week, tailored nutrition and physical activity program comprised of virtual and in-person classes.
| Study group | Role | What they receive |
|---|---|---|
| Cardiac Lifestyle Program | Experimental | 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. Receives: Behavioral: Cardiac Lifestyle Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Enrollment to end of the 3 month follow-up of last patient enrolled
Secondary outcomes (6)
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.
Measured: Baseline and Week 12 (end of program completion)
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.
Measured: Baseline and Week 12 (end of program completion)
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.
Measured: Baseline and Week 12 (end of program completion)
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.
Measured: Baseline and Week 12 (end of program completion)
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.
Measured: Baseline and Week 12 (end of program completion)
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%.
Measured: Baseline and Week 12 (end of program completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 Mar 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative DisordersStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriela Hobbs, Massachusetts General Hospital
- Investigators
- Gabriela Hobbs, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842603
- Sponsor's protocol ID
- 22-692
- Status last verified
- Sep 2025
- First submitted
- 10 Apr 2023
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I Can Move With Purpose Now! A Pilot Lifestyle Intervention Study in Myeloproliferative Neoplasm Patients
- ClinicalTrials.gov ID
- NCT05842603
- Acronym / sponsor ID
- 22-692
- Conditions
- Myeloproliferative Disorders, Leukemia
- Keywords
- Myeloproliferative Disorders, Leukemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Detailed 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiac Lifestyle Program | Experimental | Behavioral: Cardiac Lifestyle ProgramParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- -≥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.
Key exclusion criteria (3 listed)
- -- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Lifestyle Program12-week, tailored nutrition and physical activity program comprised of virtual and in-person classes. | Behavioural | Cardiac Lifestyle Program |
Primary outcome
Number of Participants that Complete at Least 9 Weeks of the 12 week Program
Time frame: 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.
6 secondary outcomes
Change in MPN SAF-TSS Score from Baseline to Week 12
Time frame: Baseline and Week 12 (end of program completion)
Change in FACIT-Fatigue Score from Baseline to Week 12
Time frame: Baseline and Week 12 (end of program completion)
Change in HADS Score from Baseline to Week 12
Time frame: Baseline and Week 12 (end of program completion)
Change in IPAQ Short Form Score from Baseline to Week 12
Time frame: Baseline and Week 12 (end of program completion)
Changes in Healthy Eating Index (HEI) Score from Baseline to Week 12
Time frame: Baseline and Week 12 (end of program completion)
Hematologic Response Rate
Time frame: Baseline and Week 12 (end of program completion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: [contact information for Sponsor Investigator or designee]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gabriela Hobbs, MD principal investigator
Massachusetts General Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiac Lifestyle Program in people with Myeloproliferative Disorders and Leukemia, run by Massachusetts General Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriela Hobbs, MD (617-724-1124, ghobbs@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants that Complete at Least 9 Weeks of the 12 week Program (time frame: Enrollment to end of the 3 month follow-up of last patient enrolled). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.