Health TrialsbyHealthPanel

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

ConditionMyeloproliferative Neoplasms (MPNs)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorBrigham and Women's Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Unable to comprehend and speak English

Unable to provide informed consent

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: WELL-MPN Digital AppExperimental treatment 1 intervention
Group B: Enhanced Usual CareNo intervention 0 interventions

Trial outcomes

Primary outcomes

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.

Time frame
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.

Time frame
Enrollment to 16 weeks after enrollment

Secondary outcomes

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).

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
Enrollment to 16 weeks after enrollment.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brigham and Women's Hospital

Lead sponsor

Source ClinicalTrials.gov

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