Multiple Myeloma/Chronic Lymphocytic Leukemia Coach RCT

NCT05928156 | Completed

• 1 other identifier: Pro00105025
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

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).

Conditions

Multiple Myeloma; Chronic Lymphocytic Leukemia

Keywords

MM; CLL

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (2)

Myeloma Coach or CLL Coach Mobile App

EXPERIMENTAL

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.

Other: Myeloma Coach or CLL Coach Mobile App

Springboard Beyond Cancer informational website

PLACEBO COMPARATOR

Other: Springboard Beyond Cancer informational website

Interventions

Myeloma Coach or CLL Coach Mobile App OTHER

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.

Myeloma Coach or CLL Coach Mobile App

Springboard Beyond Cancer informational website OTHER

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.

Springboard Beyond Cancer informational website

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University

Durham, North Carolina, 27708, United States

Location

Related Publications (1)

• LeBlanc MR, LeBlanc TW, Yang Q, McLaughlin J, Irish K, Smith SK. A Mobile App to Support Self-Management in Patients with Multiple Myeloma or Chronic Lymphocytic Leukemia: Pilot Randomized Controlled Trial. JMIR Cancer. 2023 Jul 6;9:e44533. doi: 10.2196/44533.

  PMID: 37410541 DERIVED

MeSH Terms

Conditions

Multiple Myeloma; Leukemia, Lymphocytic, Chronic, B-Cell

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases; Leukemia, B-Cell; Leukemia, Lymphoid; Leukemia; Lymphatic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2023
• First Posted: July 3, 2023
• Study Start: December 17, 2020
• Primary Completion: September 19, 2021
• Study Completion: September 19, 2021
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)