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

Study Timeline

• Study Start: 2020-12-17
• Primary Completion: 2021-09-19
• Study Completion: 2021-09-19
• Status Verified: 2023-06
• Study First Submitted: 2023-06-23
• Study First Submitted QC: 2023-06-23
• Last Update Submitted: 2023-06-23
• Study First Posted: 2023-07-03
• Last Update Posted: 2023-07-03

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

Name	Time	Method
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 Health	Baseline, 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 Thermometer	Baseline, 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.

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States