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Not yet recruiting NCT07349134

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

No phase Interventional Myeloproliferative Neoplasms (MPNs)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: WELL-MPN Digital App.
Who it may be relevant to
Registry conditions: Myeloproliferative Neoplasms (MPNs). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

  • 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.

Primary outcome measures

  • 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]
  • 8-Item Client Satisfaction Scores (CSQ-8) [Time frame: Enrollment to 16 weeks after enrollment]
Secondary outcome measures (7)
  • 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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Mass General Brigham — Boston

Identifiers

NCT: NCT07349134 · 25-805

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗