Multiple MyelomaNCT06041698
Two Implementation Strategies for the Collection of Electronic Patient-Reported Outcomes Among Patients With Multiple Myeloma
A study testing Planned Notification, Survey Administration and Behavioral Intervention in people with Multiple Myeloma, run by Thomas Jefferson University at 1 site in United States.
Trial summary
This clinical trial evaluates satisfaction and engagement with a text messaging platform (TXT-Chatbot) compared to a patient portal system (MyChart/Patient Portal) for reporting symptoms among patients with multiple myeloma (MM). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Planned Notification, Survey Administration and Behavioral Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2023to 17 Jan 2025
- 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
- Diagnosis of MM
- Able to use TXT or have Internet access
- Can read and understand English
- If patients are undergoing an autologous stem cell transplant, they will be enrolled after their transplant
Who cannot join
- < 18 years of age
- Cognitive impairment documented in the electronic medical record (EMR)
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Testing Two Implementation Strategies in Collecting ePRO Among Multiple Myeloma Patients: ePRO4MM
This clinical trial evaluates satisfaction and engagement with a text messaging platform (TXT-Chatbot) compared to a patient portal system (MyChart/Patient Portal) for reporting symptoms among patients with multiple myeloma (MM). Multiple myeloma is the third most common hematologic (relating to the blood and blood-forming organs) cancer. Patients with MM typically receive continuous therapy from the time of diagnosis, which often comes with treatment-related toxicities. Symptom burden and health-related quality of life (HRQOL) for those with MM can be quite poor. Effects of MM and its treatment may impact HRQOL domains such as physical and emotional well-being, social functioning, and financial burden. Assessment of toxicities through patient-reported outcome (PRO) measures is critical and can generate information to help facilitate clinical decision making and follow up care. PROs are direct reports from patients about their health status. Compared with paper versions, electronic PROs (ePRO) allow patients to report their symptoms in real time outside of their clinic visit, facilitate direct data collection through the electronic health record, and enable clinicians to track symptoms long-term. The use of ePROs is associated with improved patient health outcomes, including better quality of life, reduced emergency department usage, and prolonged overall survival. The increased use of electronic communication technologies to capture PRO data long-term has been implemented through various methods including web-based, social media, text messages, mobile applications, and electronic portals. Text messaging is an accessible, though under-explored, communication channel for promoting ePRO collection. Information gathered from this study may help researchers understand MM patients' preferences for reporting symptoms via text message compared to a patient portal system.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the patients' preference of TXT-Chatbot approach versus MyChart/Patient Portal approach, considering their demographic information.
II. To evaluate each patient's adherence to the approach of his/her own choice by examining their utilization of the ePRO.
SECONDARY OBJECTIVE:
- To examine the usability and satisfaction of the two implementation approaches of each patient's choice.
EXPLORATORY OBJECTIVE:
- To explore and measure any differences in patients' preference of TXT-Chatbot approach versus MyChart/Patient Portal approach, as well as the number of completed of ePRO responses, in the course of 6 months, reported between race (African American versus [vs.] Caucasian) and approaches (Chatbot vs. MyChart/Patient Portal).
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients receive a text message notification and complete surveys through TXT-Chatbot once every two weeks (Q2W) for 6 months.
GROUP II: Patients receive an email notification and complete surveys through MyChart/Patient Portal Q2W for 6 months.
After completion of study intervention, patients are followed up for 30 days.
- Conditions
- Multiple Myeloma
- Being tested
- Planned Notification, Survey Administration, Behavioral Intervention, Electronic Health Record Review, Interview
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Planned NotificationOther
Also called PlannedNotification
Receive text notification
Survey AdministrationOther
Complete surveys
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior Therapy
Participate in TXT-Chatbot
Electronic Health Record ReviewOther
Ancillary studies
InterviewOther
Ancillary studies
Survey AdministrationOther
Complete surveys
Planned NotificationOther
Also called PlannedNotification
Receive email notification
Behavioral InterventionBehavioural
Also called Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior Therapy
Participate in MyChart/Patient Portal
Electronic Health Record ReviewOther
Ancillary studies
InterviewOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Group I (TXT-Chatbot ) | Experimental | Patients receive a text message notification and complete surveys through TXT-Chatbot Q2W for 6 months. Receives: Other: Planned Notification; Other: Survey Administration; Behavioral: Behavioral Intervention; Other: Electronic Health Record Review; Other: Interview |
| Group II (MyChart/Patient Portal) | Experimental | Patients receive an email notification and complete surveys through MyChart/Patient Portal Q2W for 6 weeks. Receives: Other: Survey Administration; Other: Planned Notification; Behavioral: Behavioral Intervention; Other: Electronic Health Record Review; Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is the number of completed ePRO responses, assessed in the course of 6 months, based on group. This is a numeric endpoint.
This is a numeric endpoint.
For the primary analysis, the number of completed ePRO responses, over the course of 6 months, will be summarized using means and standard deviations, for the two implementation approaches. Multivariable Poisson regression analysis will be performed to explore the relationship between this endpoint and implementation approaches, age, gender, etc., with special consideration of the interaction between race (African American vs. Caucasian) and implementation approaches.
Measured: At 6 months
Secondary outcomes (1)
The second endpoint is patients' satisfaction from survey at the end of the intervention.
The survey contains six (6) questions with Likert scale of responses (very dissatisfied, dissatisfied, neutral, satisfied, very satisfied). A score of 1-5 is assigned to the Likert scales. The overall satisfaction score is defined as the average of scores of the six questions. This is considered as a numeric endpoint.
For the secondary analysis, the overall satisfaction score with be summarized using means and standard deviations for the two choices of approaches. The dichotomized satisfaction score (overall score >= 3.5) will be summarized using percentages for the two approaches. Multivariable (non-)linear and logistic regression models will be performed to explore the relationship between the endpoints and implementation approaches, age, gender, etc.
Measured: At 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start13 Jun 2023
- Primary completion17 Jan 2025
- Study completion17 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06041698
- Sponsor's protocol ID
- iRISID-2022-1329
- Other IDs
- JT 29004
- Status last verified
- Jul 2025
- First submitted
- 18 Aug 2023
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing Two Implementation Strategies in Collecting ePRO Among Multiple Myeloma Patients: ePRO4MM
- ClinicalTrials.gov ID
- NCT06041698
- Acronym / sponsor ID
- iRISID-2022-1329
- Conditions
- Multiple Myeloma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 13 Jun 2023 (actual)
- Primary completion
- 17 Jan 2025 (actual)
- Study completion
- 17 Jan 2025 (actual)
- First posted
- 18 Sep 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.
This clinical trial evaluates satisfaction and engagement with a text messaging platform (TXT-Chatbot) compared to a patient portal system (MyChart/Patient Portal) for reporting symptoms among patients with multiple myeloma (MM). Multiple myeloma is the third most common hematologic (relating to the blood and blood-forming organs) cancer. Patients with MM typically receive continuous therapy from the time of diagnosis, which often comes with treatment-related toxicities. Symptom burden and health-related quality of life (HRQOL) for those with MM can be quite poor. Effects of MM and its treatment may impact HRQOL domains such as physical and emotional well-being, social functioning, and financial burden. Assessment of toxicities through patient-reported outcome (PRO) measures is critical and can generate information to help facilitate clinical decision making and follow up care. PROs are direct reports from patients about their health status. Compared with paper versions, electronic PROs (ePRO) allow patients to report their symptoms in real time outside of their clinic visit, facilitate direct data collection through the electronic health record, and enable clinicians to track symptoms long-term. The use of ePROs is associated with improved patient health outcomes, including better quality of life, reduced emergency department usage, and prolonged overall survival. The increased use of electronic communication technologies to capture PRO data long-term has been implemented through various methods including web-based, social media, text messages, mobile applications, and electronic portals. Text messaging is an accessible, though under-explored, communication channel for promoting ePRO collection. Information gathered from this study may help researchers understand MM patients' preferences for reporting symptoms via text message compared to a patient portal system.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the patients' preference of TXT-Chatbot approach versus MyChart/Patient Portal approach, considering their demographic information.
II. To evaluate each patient's adherence to the approach of his/her own choice by examining their utilization of the ePRO.
SECONDARY OBJECTIVE:
- To examine the usability and satisfaction of the two implementation approaches of each patient's choice.
EXPLORATORY OBJECTIVE:
- To explore and measure any differences in patients' preference of TXT-Chatbot approach versus MyChart/Patient Portal approach, as well as the number of completed of ePRO responses, in the course of 6 months, reported between race (African American versus [vs.] Caucasian) and approaches (Chatbot vs. MyChart/Patient Portal).
OUTLINE: Patients are assigned to 1 of 2 groups.
GROUP I: Patients receive a text message notification and complete surveys through TXT-Chatbot once every two weeks (Q2W) for 6 months.
GROUP II: Patients receive an email notification and complete surveys through MyChart/Patient Portal Q2W for 6 months.
After completion of study intervention, patients are followed up for 30 days.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I (TXT-Chatbot ) | Experimental | Other: Planned Notification, Other: Survey Administration, Behavioral: Behavioral Intervention, Other: Electronic Health Record Review, Other: InterviewPatients receive a text message notification and complete surveys through TXT-Chatbot Q2W for 6 months. |
| Group II (MyChart/Patient Portal) | Experimental | Other: Survey Administration, Other: Planned Notification, Behavioral: Behavioral Intervention, Other: Electronic Health Record Review, Other: InterviewPatients receive an email notification and complete surveys through MyChart/Patient Portal Q2W for 6 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of MM
- Able to use TXT or have Internet access
- Can read and understand English
- If patients are undergoing an autologous stem cell transplant, they will be enrolled after their transplant
Key exclusion criteria (2 listed)
- < 18 years of age
- Cognitive impairment documented in the electronic medical record (EMR)
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 |
|---|---|---|
| Planned NotificationAlso: PlannedNotificationReceive text notification | Other | Group I (TXT-Chatbot ) |
| Survey AdministrationComplete surveys | Other | Group I (TXT-Chatbot ) |
| Behavioral InterventionAlso: Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior TherapyParticipate in TXT-Chatbot | Behavioural | Group I (TXT-Chatbot ) |
| Electronic Health Record ReviewAncillary studies | Other | Group I (TXT-Chatbot ) |
| InterviewAncillary studies | Other | Group I (TXT-Chatbot ) |
| Survey AdministrationComplete surveys | Other | Group II (MyChart/Patient Portal) |
| Planned NotificationAlso: PlannedNotificationReceive email notification | Other | Group II (MyChart/Patient Portal) |
| Behavioral InterventionAlso: Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior TherapyParticipate in MyChart/Patient Portal | Behavioural | Group II (MyChart/Patient Portal) |
| Electronic Health Record ReviewAncillary studies | Other | Group II (MyChart/Patient Portal) |
| InterviewAncillary studies | Other | Group II (MyChart/Patient Portal) |
Primary outcome
The primary endpoint is the number of completed ePRO responses, assessed in the course of 6 months, based on group. This is a numeric endpoint.
Time frame: At 6 months
This is a numeric endpoint. For the primary analysis, the number of completed ePRO responses, over the course of 6 months, will be summarized using means and standard deviations, for the two implementation approaches. Multivariable Poisson regression analysis will be performed to explore the relationship between this endpoint and implementation approaches, age, gender, etc., with special consideration of the interaction between race (African American vs. Caucasian) and implementation approaches.
1 secondary outcome
The second endpoint is patients' satisfaction from survey at the end of the intervention.
Time frame: At 6 months
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 28 Jul 2025.
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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 Planned Notification, Survey Administration and Behavioral Intervention in people with Multiple Myeloma, run by Thomas Jefferson 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 4 inclusion and 2 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 28 Jul 2025. 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. 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?
The primary endpoint is the number of completed ePRO responses, assessed in the course of 6 months, based on group. This is a numeric endpoint. (time frame: At 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2025.