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

Primary Purpose

Myeloproliferative Disorders, Leukemia

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiac Lifestyle Program
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Myeloproliferative Disorders focused on measuring Myeloproliferative Disorders, Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Brigham and Women's Hospital
  • Dana-Farber Cancer Institute
  • Massachusetts General Hospital Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cardiac Lifestyle Program

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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%.

Full Information

First Posted
April 10, 2023
Last Updated
May 1, 2023
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05842603
Brief Title
I Can Move With Purpose Now! A Pilot Lifestyle Intervention Study in Myeloproliferative Neoplasm Patients
Official Title
I Can Move With Purpose Now! A Pilot Lifestyle Intervention Study in Myeloproliferative Neoplasm Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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)
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myeloproliferative Disorders, Leukemia
Keywords
Myeloproliferative Disorders, Leukemia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cardiac Lifestyle Program
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cardiac Lifestyle Program
Intervention Description
12-week, tailored nutrition and physical activity program comprised of virtual and in-person classes.
Primary Outcome Measure Information:
Title
Number of Participants that Complete at Least 9 Weeks of the 12 week Program
Description
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.
Time Frame
Enrollment to end of the 3 month follow-up of last patient enrolled
Secondary Outcome Measure Information:
Title
Change in MPN SAF-TSS Score from Baseline to Week 12
Description
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.
Time Frame
Baseline and Week 12 (end of program completion)
Title
Change in FACIT-Fatigue Score from Baseline to Week 12
Description
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.
Time Frame
Baseline and Week 12 (end of program completion)
Title
Change in HADS Score from Baseline to Week 12
Description
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.
Time Frame
Baseline and Week 12 (end of program completion)
Title
Change in IPAQ Short Form Score from Baseline to Week 12
Description
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.
Time Frame
Baseline and Week 12 (end of program completion)
Title
Changes in Healthy Eating Index (HEI) Score from Baseline to Week 12
Description
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.
Time Frame
Baseline and Week 12 (end of program completion)
Title
Hematologic Response Rate
Description
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%.
Time Frame
Baseline and Week 12 (end of program completion)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriela Hobbs, MD
Phone
617-724-1124
Email
ghobbs@partners.org
First Name & Middle Initial & Last Name or Official Title & Degree
Gabriella Hobbs, MD
Phone
617-724-1124
Email
ghobbs@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriela Hobbs, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriela Hobbs, MD
Phone
617-724-1124
Email
ghobbs@partners.org
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriela Hobbs, MD
Phone
617-724-1124
Email
ghobbs@partners.org
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gabriela Hobbs, MD
Phone
617-724-1124
Email
ghobbs@partners.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication
IPD Sharing Access Criteria
Contact the Partners Innovations team at http://www.partners.org/innovation.

Learn more about this trial

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

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