Two Implementation Strategies for the Collection of Electronic Patient-Reported Outcomes Among Patients With Multiple Myeloma

NCT06041698 | Completed

• 2 other identifiers: iRISID-2022-1329JT 29004
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Multiple Myeloma

Outcome Measures

Primary Outcomes (1)

• 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.

  At 6 months

Secondary Outcomes (1)

• The second endpoint is patients' satisfaction from survey at the end of the intervention.

  At 6 months

Study Arms (2)

Group I (TXT-Chatbot )

EXPERIMENTAL

Patients receive a text message notification and complete surveys through TXT-Chatbot Q2W for 6 months.

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.

Other: Survey Administration; Other: Planned Notification; Behavioral: Behavioral Intervention; Other: Electronic Health Record Review; Other: Interview

Interventions

Planned Notification OTHER

Receive text notification

Also known as: PlannedNotification

Group I (TXT-Chatbot )

Survey Administration OTHER

Complete surveys

Group I (TXT-Chatbot )

Behavioral Intervention BEHAVIORAL

Participate in TXT-Chatbot

Also known as: Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, BEHAVIORAL THERAPY, Behavioral Treatment, Behavioral Treatments

Group I (TXT-Chatbot )

Electronic Health Record Review OTHER

Ancillary studies

Group I (TXT-Chatbot )

Interview OTHER

Ancillary studies

Group I (TXT-Chatbot )

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• \< 18 years of age
• Cognitive impairment documented in the electronic medical record (EMR)

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Behavior Therapy; Interviews as Topic

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

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: September 18, 2023
• Study Start: June 13, 2023
• Primary Completion: January 17, 2025
• Study Completion: January 17, 2025
• Last Updated: July 28, 2025

Record last verified: 2025-07

Locations

US (1)