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Completed

NCT Number: NCT05928156

Multiple Myeloma/Chronic Lymphocytic Leukemia Coach RCT

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27708, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Edmonton Symptom Assessment Scale (ESAS)

    Time frame: 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.

  2. Change in NCCN Distress Thermometer

    Time frame: 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.

  3. Change in PROMIS (Patient-Reported Outcomes Measurement Information System) Short Form Global Health

    Time frame: 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.

  4. Change in severity of PTSD related symptoms as measured by PTSD Checklist (PCL5)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Blood Cancer Symptom Management App Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 3, 2023
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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