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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)
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cardiac Lifestyle Program | Experimental | Participants will complete study procedures as follows:
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|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac Lifestyle Program | Behavioral | 12-week, tailored nutrition and physical activity program comprised of virtual and in-person classes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
-≥18 years of age
Exclusion Criteria:
-- MF patients with intermediate-2 or high-risk disease by DIPSS
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gabriela Hobbs, MD | Contact | 617-724-1124 | ghobbs@partners.org | |
| Gabriella Hobbs, MD | Contact | 617-724-1124 | ghobbs@partners.org |
| Name | Affiliation | Role |
|---|---|---|
| Gabriela Hobbs, MD | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Recruiting | Boston | Massachusetts | 02215 | United States |
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.
Data can be shared no earlier than 1 year following the date of publication
Contact the Partners Innovations team at http://www.partners.org/innovation.
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| ID | Term |
|---|---|
| D009196 | Myeloproliferative Disorders |
| D007938 | Leukemia |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009370 | Neoplasms by Histologic Type |
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| 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) |
| 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) |
| 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) |
| 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) |
| 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) |
| Dana-Farber Cancer Institute | Not yet recruiting | Boston | Massachusetts | 02215 | United States |
|
| Massachusetts General Hospital Cancer Center | Recruiting | Boston | Massachusetts | 02215 | United States |
|
| D009369 | Neoplasms |