WELL-MPN: A Digital Lifestyle App for Patients With MPNs

NCT07349134 | Not Yet Recruiting

• 1 other identifier: 25-805
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn whether a digital lifestyle app can help improve diet, physical activity, symptoms, emotional well-being, and quality of life in adults with myeloproliferative neoplasms (MPNs). The main questions it aims to answer are: Can people with MPNs use the WELL-MPN app? Does using the WELL-MPN app improve diet quality and physical activity? Does the WELL-MPN app improve MPN-related symptoms, anxiety and depression, confidence in managing health, and overall quality of life? Researchers will compare participants who use the WELL-MPN digital app with participants who receive written educational materials about diet and physical activity for people with cancer to see if the app leads to greater improvements in lifestyle behaviors, symptoms, and well-being. Participants will: Be randomly assigned to use the WELL-MPN app or receive written lifestyle education materials Use the assigned program or materials over the study period Complete surveys about diet, physical activity, symptoms, mood, confidence in self-care, and quality of life

Conditions

Myeloproliferative Neoplasms (MPNs)

Keywords

Myeloproliferative Neoplasms; Essential Thrombocythemia; Polycythemia Vera; Myelofibrosis

Outcome Measures

Primary Outcomes (2)

• Number of patients consented and enrolled onto the study, and number of patients who complete at least 2 out of 3 modules in the app.

  Primary outcome is feasibility, defined as ≥60% enrollment of eligible patients and ≥70% of patients randomized to the intervention group completing at least 2 out of 3 of app modules.

  2 years

• 8-Item Client Satisfaction Scores (CSQ-8)

  Acceptability of WELL-MPN as measured by CSQ-8 scores of WELL-MPN. The CSQ-8 is a self-report tool designed to measure patient satisfaction with a received intervention. It consists of 8 items rated on a 4-point Likert scale (from "quite dissatisfied" to "very satisfied"), with higher scores indicating greater satisfaction. WELL-MPN is considered acceptable if \>80% of participants on the WELL-MPN arm report a CSQ-8 score \>20.

  Enrollment to 16 weeks after enrollment

Secondary Outcomes (7)

• Healthy Eating Index calculated from the Automated Self-Administered Dietary Assessment Tool

  Enrollment to 16 weeks after enrollment.

• Mini Eating Assessment Tool (Mini-EAT) score

  Enrollment to 16 weeks after enrollment.

• Godin Leisure Time Exercise Questionnaire

  Enrollment to 16 weeks after enrollment.

• Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy Short Forms

  Enrollment to 16 weeks after enrollment.

• MPN Symptom Assessment Form (SAF) Total Symptom Score (TSS)

  Enrollment to 16 weeks after enrollment.

Study Arms (2)

WELL-MPN Digital App

EXPERIMENTAL

WELL-MPN app and usual care

Behavioral: WELL-MPN Digital App

Enhanced Usual Care

NO INTERVENTION

Usual care and written literature about diet and physical activity guidelines in patients with cancer

Interventions

WELL-MPN Digital App BEHAVIORAL

Patients randomized to the WELL-MPN arm will be given access to the WELL-MPN digital program (app) which provides lifestyle counseling through an iPad.

WELL-MPN Digital App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with a myeloproliferative neoplasm (MPN) by World Health Organization 2016 criteria
• Adult (age \>/= 18)
• Able to comprehend and speak English
• Able to provide informed consent

You may not qualify if:

• Unable to comprehend and speak English
• Unable to provide informed consent

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Mass General Brigham

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Myeloproliferative Disorders; Thrombocythemia, Essential; Polycythemia Vera; Primary Myelofibrosis

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; Blood Coagulation Disorders; Thrombocytosis; Blood Platelet Disorders; Hemorrhagic Disorders; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Chi-Joan How

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi-Joan How

CONTACT

617-732-5190; jhow@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 16, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: January 20, 2026

Record last verified: 2026-01

Locations

US (1)