Multiple MyelomaNCT05928156
Multiple Myeloma/Chronic Lymphocytic Leukemia Coach RCT
A study testing Myeloma Coach or CLL Coach Mobile App and Springboard Beyond Cancer informational website in people with Multiple Myeloma and Chronic Lymphocytic Leukemia, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma, Chronic Lymphocytic Leukemia
- What is being tested?
- Myeloma Coach or CLL Coach Mobile App and Springboard Beyond Cancer informational website
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 77 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Dec 2020to 19 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Blood Cancer Symptom Management App Randomized Controlled Trial
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
- Being tested
- Myeloma Coach or CLL Coach Mobile App, Springboard Beyond Cancer informational website
- Keywords
- MM, CLL
- Medical subject headings
- Multiple Myeloma, Leukemia, Lymphocytic, Chronic, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myeloma Coach or CLL Coach Mobile AppOther
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 websiteOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Myeloma Coach or CLL Coach Mobile App |
| Springboard Beyond Cancer informational website | Placebo comparator | Not described Receives: Other: Springboard Beyond Cancer informational website |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 4 weeks, 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start17 Dec 2020
- Primary completion19 Sep 2021
- Study completion19 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928156
- Sponsor's protocol ID
- Pro00105025
- Status last verified
- Jun 2023
- First submitted
- 23 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37410541
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Cancer Symptom Management App Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05928156
- Acronym / sponsor ID
- Pro00105025
- Conditions
- Multiple Myeloma, Chronic Lymphocytic Leukemia
- Keywords
- MM, CLL
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 17 Dec 2020 (actual)
- Primary completion
- 19 Sep 2021 (actual)
- Study completion
- 19 Sep 2021 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Myeloma Coach or CLL Coach Mobile App | Experimental | Other: Myeloma Coach or CLL Coach Mobile AppParticipants 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. |
| Springboard Beyond Cancer informational website | Placebo comparator | Other: Springboard Beyond Cancer informational website |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Myeloma Coach or CLL Coach Mobile AppSymptom 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. | Other | Myeloma Coach or CLL Coach Mobile App |
| Springboard Beyond Cancer informational websiteSpringboard 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. | Other | Springboard Beyond Cancer informational website |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Derived from this study: PubMed 37410541LeBlanc 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Myeloma Coach or CLL Coach Mobile App and Springboard Beyond Cancer informational website in people with Multiple Myeloma and Chronic Lymphocytic Leukemia, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Edmonton Symptom Assessment Scale (ESAS) (time frame: Baseline, 4 weeks, 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05928156, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.