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Myeloproliferative Neoplasms (MPNs)WELL-MPNNCT07349134

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

A study testing WELL-MPN Digital App in people with Myeloproliferative Neoplasms (MPNs), run by Brigham and Women's Hospital at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record

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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myeloproliferative Neoplasms (MPNs)
What is being tested?
WELL-MPN Digital App
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteUnited States
Study dates
Jan 2027to Jul 2029
Phase
Interventional

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

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Mass General Brigham

    Boston, Massachusetts, 02115

    Chi-Joan How, 6177325190, jhow@bwh.harvard.edu

Other trials in United States

About this study

Official title: 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:

Read more

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

Being tested
WELL-MPN Digital App
Keywords
Myeloproliferative Neoplasms, Essential Thrombocythemia, Polycythemia Vera, Myelofibrosis
Medical subject headings
Myeloproliferative Disorders, Thrombocythemia, Essential, Polycythemia Vera, Primary Myelofibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WELL-MPN Digital AppBehavioural

    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.

Study groups in NCT07349134
Study groupRoleWhat they receive
WELL-MPN Digital AppExperimentalWELL-MPN app and usual care
Receives: Behavioral: WELL-MPN Digital App
Enhanced Usual CareNo interventionUsual care and written literature about diet and physical activity guidelines in patients with cancer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 years

  2. 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.

    Measured: Enrollment to 16 weeks after enrollment

Secondary outcomes (7)
  1. Healthy Eating Index calculated from the Automated Self-Administered Dietary Assessment Tool

    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).

    Measured: Enrollment to 16 weeks after enrollment.

  2. Mini Eating Assessment Tool (Mini-EAT) score

    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.

    Measured: Enrollment to 16 weeks after enrollment.

  3. Godin Leisure Time Exercise Questionnaire

    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.

    Measured: Enrollment to 16 weeks after enrollment.

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

    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.

    Measured: Enrollment to 16 weeks after enrollment.

  5. MPN Symptom Assessment Form (SAF) Total Symptom Score (TSS)

    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.

    Measured: Enrollment to 16 weeks after enrollment.

  6. Hospital Anxiety and Depression Scale (HADS-A and HADS-D):

    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.

    Measured: Enrollment to 16 weeks after enrollment.

  7. Functional Assessment of Cancer - General (FACT-G)

    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.

    Measured: Enrollment to 16 weeks after enrollment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jan 2026
  2. Study startJan 2027 (estimated)
  3. Primary completionJul 2029 (estimated)
  4. Study completionJul 2029 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07349134
Sponsor's protocol ID
25-805
Acronym
WELL-MPN
Status last verified
Jan 2026
First submitted
9 Jan 2026
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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