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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
- Are there results?
- Not yet: the study is under way
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
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
- Conditions
- Myeloproliferative Neoplasms (MPNs)
- 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 group | Role | What they receive |
|---|---|---|
| WELL-MPN Digital App | Experimental | WELL-MPN app and usual care Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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.
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.
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.
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.
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.
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.
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.
- First posted16 Jan 2026
- Study startJan 2027 (estimated)
- Primary completionJul 2029 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myeloproliferative Neoplasms (MPNs)Studies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi-Joan How, MD, Brigham and Women's Hospital
- Investigators
- Chi-Joan How, Principal investigator, Massachusetts General Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Randomized Controlled Trial of a Digital Intervention to Promote Wellness, Empowerment, and Lifestyle Learning for Patients With Myeloproliferative Neoplasms (WELL-MPN)
- ClinicalTrials.gov ID
- NCT07349134
- Acronym / sponsor ID
- WELL-MPN / 25-805
- Conditions
- Myeloproliferative Neoplasms (MPNs)
- Keywords
- Myeloproliferative Neoplasms, Essential Thrombocythemia, Polycythemia Vera, Myelofibrosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jul 2029 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WELL-MPN Digital App | Experimental | Behavioral: WELL-MPN Digital AppWELL-MPN app and usual care |
| Enhanced Usual Care | No intervention | –Usual care and written literature about diet and physical activity guidelines in patients with cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Unable to comprehend and speak English
- Unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WELL-MPN Digital AppPatients randomized to the WELL-MPN arm will be given access to the WELL-MPN digital program (app) which provides lifestyle counseling through an iPad. | Behavioural | WELL-MPN Digital App |
Primary outcome
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.
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.
7 secondary outcomes
Healthy Eating Index calculated from the Automated Self-Administered Dietary Assessment Tool
Time frame: Enrollment to 16 weeks after enrollment.
Mini Eating Assessment Tool (Mini-EAT) score
Time frame: Enrollment to 16 weeks after enrollment.
Godin Leisure Time Exercise Questionnaire
Time frame: 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.
MPN Symptom Assessment Form (SAF) Total Symptom Score (TSS)
Time frame: Enrollment to 16 weeks after enrollment.
Hospital Anxiety and Depression Scale (HADS-A and HADS-D):
Time frame: Enrollment to 16 weeks after enrollment.
Functional Assessment of Cancer - General (FACT-G)
Time frame: Enrollment to 16 weeks after enrollment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
Related trials for Myeloproliferative Neoplasms (MPNs)
RecruitingPhase 1
A Phase 1 Study of PRT12396 in Participants With Select Myeloproliferative Neoplasms
Polycythemia Vera (PV), Myelofibrosis (MF)
RecruitingPhase 1
A Study to Evaluate DMR-001 in Participants With CALR-mutant Myeloproliferative Neoplasms
Myeloproliferative Neoplasms (MPNs)
Active, not recruitingPhase 1
Study of Oral LY3410738 in Patients With Advanced Hematologic Malignancies With IDH1 or IDH2 Mutations
Acute Myeloid Leukemia (AML), Myelodysplastic Syndrome (MDS)
RecruitingObservational study
MPN PROGRESSion Registry: Observational Study Tracking Symptoms, Treatments, and Disease Progression in People With Myeloproliferative Neoplasms (MPNs)
Polycythemia Vera, ET (Essential Thrombocythemia)
Not yet recruitingObservational study
Clinical Significance of Leukocyte Cell Population Data in Patients With Myeloproliferative Neoplasms (MPNs)
Myeloproliferative Neoplasms (MPNs)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chi-Joan How principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chi-Joan How (617-732-5190, jhow@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.