MedPath

Multiple Myeloma/Chronic Lymphocytic Leukemia Coach RCT

Not Applicable
Completed
Conditions
Multiple Myeloma
Chronic Lymphocytic Leukemia
Registration Number
NCT05928156
Lead Sponsor
Duke University
Brief Summary

The purpose of this study is to test the effectiveness of evidence-informed mobile apps, Myeloma Coach and CLL Coach. These apps have been developed to help manage the physical and emotional symptoms experienced by multiple myeloma and chronic lymphocytic leukemia survivors. This study hopes to determine if a mobile app is a useful tool to help people manage commonly reported symptoms related to Multiple Myeloma (MM) and chronic lymphocytic leukemia (CLL).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
77
Inclusion Criteria
  • Be at least 18 years of age;
  • Be a resident of the United States of America;
  • Be able to read and write English
  • Consistent access to the internet via a smartphone, tablet or computer
  • Have a diagnosis of multiple myeloma or chronic lymphocytic leukemia
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Change in Edmonton Symptom Assessment Scale (ESAS)Baseline, 4 weeks, 8 weeks

The ESAS is a validated 10 item survey index used to assessed symptoms. The total ranges from 0 to 60, with a higher score indicating higher physical symptom burden.

Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Short Form Global HealthBaseline, 4 weeks, 8 weeks

This validated 10 item survey captures a person's self assessment of their global physical and global mental health. The possible score ranges from 0 to 20 points in each case. 0 points represent the patient's most severe physical and/or mental impairment, while 20 points represent the best possible state of health.

Change in NCCN Distress ThermometerBaseline, 4 weeks, 8 weeks

The NCCN Distress Thermometer (DT) is a one-item, 11-point Likert scale represented on a visual graphic of a thermometer that ranges from 0 (no distress) to 10 (extreme distress), with which patients indicate their level of distress over the course of the week prior to assessment.

Change in severity of PTSD related symptoms as measured by PTSD Checklist (PCL5)Baseline, 4 weeks, 8 weeks

This validated 20 item measure has been used extensively in research. Scores consist of a total symptom severity score (from 0 to 80) from four subscales: Re-experiencing (items 1-5 - max score = 20), Avoidance (items 6-7 - max score = 8), Negative alterations in cognition and mood (items 8-14 - max score = 28), and Hyper-arousal (items 15-20 - max score = 24). Higher scores represent higher severity.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Duke University

🇺🇸

Durham, North Carolina, United States

Duke University
🇺🇸Durham, North Carolina, United States

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