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

Browse trials for

• Myeloproliferative Disorders 667
• Thrombocythemia, Essential 229
• Polycythemia Vera 278
• Primary Myelofibrosis 625

Keywords

• Myeloproliferative Neoplasms
• Essential Thrombocythemia
• Polycythemia Vera
• Myelofibrosis

Myeloproliferative Disorders

667 studies on the registry are indexed under Myeloproliferative Disorders; 110 are open to participants now.

This study's planned enrollment of 75 is above the median of 47 across 462 interventional studies indexed under Myeloproliferative Disorders.

Lead sponsor

Brigham and Women's Hospital is the lead sponsor of 1,267 studies on the registry; 228 are open to participants now.

Of its 116 completed or terminated interventional studies of FDA-regulated products, 65 (56%) have results posted.

Study arms

• Experimental
  WELL-MPN Digital App

  WELL-MPN app and usual care

  Behavioral: WELL-MPN Digital App

• No intervention
  Enhanced Usual Care

  Usual care and written literature about diet and physical activity guidelines in patients with cancer

Interventions

• BehavioralWELL-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 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.

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.

   Time frame: 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.

   Time frame: 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.

   Time frame: Enrollment to 16 weeks after enrollment.