Clinical trial NCT06041698: Two Implementation Strategies for the Collection of Electronic Patient-Reported Outcomes Among Patients With Multiple Myeloma
Official title: Testing Two Implementation Strategies in Collecting ePRO Among Multiple Myeloma Patients: ePRO4MM
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
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.
timeFrame: At 6 months
Secondary outcomes:
measure: The second endpoint is patients' satisfaction from survey at the end of the intervention.
timeFrame: At 6 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center at Thomas Jefferson University
state: Pennsylvania
Study officials:
References: