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Multiple Myeloma/Chronic Lymphocytic Leukemia Coach RCT

Primary Purpose

Multiple Myeloma, Chronic Lymphocytic Leukemia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Myeloma Coach or CLL Coach Mobile App
Springboard Beyond Cancer informational website
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Multiple Myeloma focused on measuring MM, CLL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Duke University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Myeloma Coach or CLL Coach Mobile App

Springboard Beyond Cancer informational website

Arm Description

Participants diagnosed with Multiple Myeloma will use the Myeloma Coach app and participants diagnosed with CLL (chronic lymphocytic leukemia) will use the the CLL Coach app. Pattern Health apps are built around "patterns" of scheduled activities. Users will encounter a list of activities to engage with for the day. There is also an option to complete activities in an ad hoc fashion.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
June 23, 2023
Last Updated
June 23, 2023
Sponsor
Duke University
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1. Study Identification

Unique Protocol Identification Number
NCT05928156
Brief Title
Multiple Myeloma/Chronic Lymphocytic Leukemia Coach RCT
Official Title
Blood Cancer Symptom Management App Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 17, 2020 (Actual)
Primary Completion Date
September 19, 2021 (Actual)
Study Completion Date
September 19, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma, Chronic Lymphocytic Leukemia
Keywords
MM, CLL

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Myeloma Coach or CLL Coach Mobile App
Arm Type
Experimental
Arm Description
Participants diagnosed with Multiple Myeloma will use the Myeloma Coach app and participants diagnosed with CLL (chronic lymphocytic leukemia) will use the the CLL Coach app. Pattern Health apps are built around "patterns" of scheduled activities. Users will encounter a list of activities to engage with for the day. There is also an option to complete activities in an ad hoc fashion.
Arm Title
Springboard Beyond Cancer informational website
Arm Type
Placebo Comparator
Intervention Type
Other
Intervention Name(s)
Myeloma Coach or CLL Coach Mobile App
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Springboard Beyond Cancer informational website
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Edmonton Symptom Assessment Scale (ESAS)
Description
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.
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change in NCCN Distress Thermometer
Description
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.
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Short Form Global Health
Description
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.
Time Frame
Baseline, 4 weeks, 8 weeks
Title
Change in severity of PTSD related symptoms as measured by PTSD Checklist (PCL5)
Description
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.
Time Frame
Baseline, 4 weeks, 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Duke University
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27708
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Multiple Myeloma/Chronic Lymphocytic Leukemia Coach RCT

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