Multiple Myeloma/Chronic Lymphocytic Leukemia Coach RCT

Multiple Myeloma Clinical Trial

Official title:

Blood Cancer Symptom Management App Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05928156
• Other study ID #: Pro00105025
• Status: Completed
• Phase: N/A
• Start date: December 17, 2020
• Est. completion date: September 19, 2021

Study information

• Verified date: June 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: September 19, 2021
• Est. primary completion date: September 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Lymphocytic Leukemia
• Leukemia
• Leukemia, Lymphocytic, Chronic, B-Cell
• Leukemia, Lymphoid
• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Other:
• Myeloma Coach or CLL Coach Mobile App
Symptom Tracking: Subjects will be asked to track their symptoms on a weekly basis, as well as given the opportunity to track these symptoms whenever they would like. Subjects will receive feedback tailored to their symptom severity with coaching on self management, including encouraging them to reach out to their health care team when symptoms are new, severe or increasing in severity. Subjects will also be able to look at graphs of symptom severity over time and share them with family and their health care team. Medication Adherence Reminders and Tracking, Activities - tools based on CBT (cognitive behavioral therapy) principles can be utilized at any time to manage emotional distress. Learn - information on cancer, its treatment, self managing physical and emotional symptoms, and supportive resources.
• Springboard Beyond Cancer informational website
Springboard Beyond Cancer (https://survivorship.cancer.gov) is designed to make it easy for those in treatment and post-treatment to access essential information to help them manage ongoing cancer-related symptoms, deal with stress, improve healthy behaviors, communicate better with healthcare teams, and seek support from friends and family.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Edmonton Symptom Assessment Scale (ESAS)	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.	Baseline, 4 weeks, 8 weeks
Primary	Change in NCCN Distress Thermometer	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.	Baseline, 4 weeks, 8 weeks
Primary	Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Short Form Global Health	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.	Baseline, 4 weeks, 8 weeks
Primary	Change in severity of PTSD related symptoms as measured by PTSD Checklist (PCL5)	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.	Baseline, 4 weeks, 8 weeks