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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06041698
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Thomas Jefferson University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Multiple Myeloma
Additional Details

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.#46; 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.

Arms & Interventions

Arms

Experimental: Group I (TXT-Chatbot )

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

Experimental: Group II (MyChart/Patient Portal)

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

Interventions

Other: - Planned Notification

Receive text notification

Other: - Survey Administration

Complete surveys

Behavioral: - Behavioral Intervention

Participate in TXT-Chatbot

Other: - Electronic Health Record Review

Ancillary studies

Other: - Interview

Ancillary studies

Other: - Survey Administration

Complete surveys

Other: - Planned Notification

Receive email notification

Behavioral: - Behavioral Intervention

Participate in MyChart/Patient Portal

Other: - Electronic Health Record Review

Ancillary studies

Other: - Interview

Ancillary studies

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Philadelphia, Pennsylvania

Status

Recruiting

Address

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107

Site Contact

Kuang-Yi Wen, MD

Kuang-Yi.Wen@Jefferson.edu

215-503-4623