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

NCT ID: NCT06041698

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-13

Study Completion Date

2025-01-17

Brief Summary

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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

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PRIMARY OBJECTIVES:

I. 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:

I. To examine the usability and satisfaction of the two implementation approaches of each patient's choice.

EXPLORATORY OBJECTIVE:

I. 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

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Multiple Myeloma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Group I (TXT-Chatbot )

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

Group Type EXPERIMENTAL

Planned Notification

Intervention Type OTHER

Receive text notification

Survey Administration

Intervention Type OTHER

Complete surveys

Behavioral Intervention

Intervention Type BEHAVIORAL

Participate in TXT-Chatbot

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Interview

Intervention Type OTHER

Ancillary studies

Group II (MyChart/Patient Portal)

Patients receive an email notification and complete surveys through MyChart/Patient Portal Q2W for 6 weeks.

Group Type EXPERIMENTAL

Survey Administration

Intervention Type OTHER

Complete surveys

Planned Notification

Intervention Type OTHER

Receive email notification

Behavioral Intervention

Intervention Type BEHAVIORAL

Participate in MyChart/Patient Portal

Electronic Health Record Review

Intervention Type OTHER

Ancillary studies

Interview

Intervention Type OTHER

Ancillary studies

Interventions

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Planned Notification

Receive text notification

Intervention Type OTHER

Survey Administration

Complete surveys

Intervention Type OTHER

Behavioral Intervention

Participate in TXT-Chatbot

Intervention Type BEHAVIORAL

Electronic Health Record Review

Ancillary studies

Intervention Type OTHER

Interview

Ancillary studies

Intervention Type OTHER

Survey Administration

Complete surveys

Intervention Type OTHER

Planned Notification

Receive email notification

Intervention Type OTHER

Behavioral Intervention

Participate in MyChart/Patient Portal

Intervention Type BEHAVIORAL

Electronic Health Record Review

Ancillary studies

Intervention Type OTHER

Interview

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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PlannedNotification Behavior Conditioning Therapy behavior modification Behavior or Life Style Modifications Behavior Therapy Behavioral Interventions Behavioral Modification BEHAVIORAL THERAPY Behavioral Treatment Behavioral Treatments PlannedNotification Behavior Conditioning Therapy behavior modification Behavior or Life Style Modifications Behavior Therapy Behavioral Interventions Behavioral Modification BEHAVIORAL THERAPY Behavioral Treatment Behavioral Treatments

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* \< 18 years of age
* Cognitive impairment documented in the electronic medical record (EMR)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Thomas Jefferson University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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JT 29004

Identifier Type: OTHER

Identifier Source: secondary_id

iRISID-2022-1329

Identifier Type: -

Identifier Source: org_study_id

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