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

January 16, 2026 updated by: Chi-Joan How, MD, Brigham and Women's Hospital

Pilot Randomized Controlled Trial of a Digital Intervention to Promote Wellness, Empowerment, and Lifestyle Learning for Patients With Myeloproliferative Neoplasms (WELL-MPN)

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WELL-MPN Digital App
WELL-MPN app and usual care
Behavioral: WELL-MPN Digital App
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.
No Intervention: Enhanced Usual Care
Usual care and written literature about diet and physical activity guidelines in patients with cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 2 years
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)
Time Frame: Enrollment to 16 weeks after enrollment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healthy Eating Index calculated from the Automated Self-Administered Dietary Assessment Tool
Time Frame: Enrollment to 16 weeks after enrollment.
Diet quality will be compared between control and WELL-MPN patients. The ASA24 is a free 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 a measure of dietary quality that addresses compliance with the 2015 United States Department of Agriculture dietary guidelines (scores range from 0 to 100, with higher scores indicating greater alignment with dietary guidelines).
Enrollment to 16 weeks after enrollment.
Mini Eating Assessment Tool (Mini-EAT) score
Time Frame: Enrollment to 16 weeks after enrollment.
Diet quality will be compared between control and WELL-MPN patients. The Mini-EAT is a 9-item validated brief dietary screener designed for greater ease of administration compared to the ASA-24 but has strong correlation with the HEI. Responses generate a score ranging from 0 to 54, with higher scores reflecting greater adherence to healthy dietary patterns aligned with the Dietary Guidelines for Americans.
Enrollment to 16 weeks after enrollment.
Godin Leisure Time Exercise Questionnaire
Time Frame: Enrollment to 16 weeks after enrollment.
Physical activity will be compared between control and WELL-MPN patients. The Godin Leisure Time Exercise Questionnaire is a brief, self-reported tool used to assess a person's usual physical activity during their free time.It consists of three questions asking information on the number of times one engages in mild, moderate, and strenuous physical activity of at least 15-minute durations in a typical week. Higher scores indicate greater physical activity, with scores of less than 14 units indicating insufficient / sedentary activity.
Enrollment to 16 weeks after enrollment.
Patient-Reported Outcomes Measurement Information System (PROMIS) Self-Efficacy Short Forms
Time Frame: Enrollment to 16 weeks after enrollment.
Self-efficacy will be compared between control and WELL-MPN patients. The PROMIS Self-Efficacy Short Forms include 4-item scales across domains such as managing daily activities, symptoms, medications, emotions, and social interactions. Each item is rated on a 5-point Likert scale, with higher scores indicating greater self-efficacy.
Enrollment to 16 weeks after enrollment.
MPN Symptom Assessment Form (SAF) Total Symptom Score (TSS)
Time Frame: Enrollment to 16 weeks after enrollment.
MPN symptom scores will be compared between control and WELL-MPN patients. The MPN SAF TSS is a 10-item questionnaire assessing the most representative and clinically relevant MPN symptoms (concentration, early satiety, inactivity, night sweats, itching, bone pain, abdominal discomfort, weight loss, fever), and includes a "worst fatigue" question from the Brief Fatigue Inventory. Each subscale ranges from 0 (absent / as good as it can be) to 10 (worst imaginable / as bad as it can be), and scores are computed as the average of the observed items multiplied by 10 to achieve a 0 to 100 scale.
Enrollment to 16 weeks after enrollment.
Hospital Anxiety and Depression Scale (HADS-A and HADS-D):
Time Frame: Enrollment to 16 weeks after enrollment.
Psychological distress will be compared between controls and WELL-MPN patients. The 14-item HADS consists of two 7-item subscales assessing anxiety and depression symptoms in the past week. Each subscale ranges from 0 (no distress) to 21 (maximum distress), with higher scores indicating worse distress. Subscale scores > 8 indicate clinically significant distress; scores can be further interpreted as follows: 8-10 indicates mild distress, 11-14 indicates moderate distress, and 15-21 indicates severe distress.
Enrollment to 16 weeks after enrollment.
Functional Assessment of Cancer - General (FACT-G)
Time Frame: Enrollment to 16 weeks after enrollment.
Quality of life will be compared between controls and WELL-MPN patients. The FACT-G consists of four subscales assessing well-being across four domains (physical, functional, emotional, and social). Subscale scores include Functional Well-Being (0-28), Social Well-Being (0-28), Emotional Well-Being (0-24), and Functional Well-Being (0-28) with higher scores reflecting better well-being in each domain.
Enrollment to 16 weeks after enrollment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Chi-Joan How, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

January 9, 2026

First Submitted That Met QC Criteria

January 9, 2026

First Posted (Estimated)

January 16, 2026

Study Record Updates

Last Update Posted (Actual)

January 20, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-805

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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