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

Primary Purpose

Multiple Myeloma

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Planned Notification
Survey Administration
Behavioral Intervention
Electronic Health Record Review
Interview
Survey Administration
Planned Notification
Behavioral Intervention
Electronic Health Record Review
Interview
Sponsored by
Thomas Jefferson University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Multiple Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Sidney Kimmel Cancer Center at Thomas Jefferson UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group I (TXT-Chatbot )

Group II (MyChart/Patient Portal)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Choice of TXT-Chatbot
The choice of implementation approaches will be summarized using percentages. Multivariable logistic regression analysis will be performed to explore the relationship between the choice of approaches and age, gender, etc.
Number of completed electronic Patient-Reported Outcome (ePRO) responses
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 versus Caucasian) and implementation approaches.

Secondary Outcome Measures

Overall Satisfaction Scores Using the Client Satisfaction Questionnaire (CSQ-8)
Participants will complete the Client Satisfaction Questionnaire (CSQ-8), a validated measure that elicits the client's perspective on the value of services received. The 8 items are rated on a 1-5 scale with higher scores indicating greater satisfaction. The overall satisfaction score will be summarized using means and standard deviations across the 8 items. The dichotomized satisfaction score (overall score ≥ 3.5) will be summarized using percentages . Multivariable (non-)linear and logistic regression models will be performed to explore the relationship between the endpoints and implementation approaches, age, gender, and other measures.

Full Information

First Posted
August 18, 2023
Last Updated
September 11, 2023
Sponsor
Thomas Jefferson University
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1. Study Identification

Unique Protocol Identification Number
NCT06041698
Brief Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 13, 2023 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Myeloma

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (TXT-Chatbot )
Arm Type
Experimental
Arm Description
Patients receive a text message notification and complete surveys through TXT-Chatbot Q2W for 6 months.
Arm Title
Group II (MyChart/Patient Portal)
Arm Type
Experimental
Arm Description
Patients receive an email notification and complete surveys through MyChart/Patient Portal Q2W for 6 weeks.
Intervention Type
Other
Intervention Name(s)
Planned Notification
Other Intervention Name(s)
PlannedNotification
Intervention Description
Receive text notification
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Complete surveys
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Intervention
Other Intervention Name(s)
Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, BEHAVIORAL THERAPY, Behavioral Treatment, Behavioral Treatments
Intervention Description
Participate in TXT-Chatbot
Intervention Type
Other
Intervention Name(s)
Electronic Health Record Review
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Interview
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Complete surveys
Intervention Type
Other
Intervention Name(s)
Planned Notification
Other Intervention Name(s)
PlannedNotification
Intervention Description
Receive email notification
Intervention Type
Behavioral
Intervention Name(s)
Behavioral Intervention
Other Intervention Name(s)
Behavior Conditioning Therapy, behavior modification, Behavior or Life Style Modifications, Behavior Therapy, Behavioral Interventions, Behavioral Modification, BEHAVIORAL THERAPY, Behavioral Treatment, Behavioral Treatments
Intervention Description
Participate in MyChart/Patient Portal
Intervention Type
Other
Intervention Name(s)
Electronic Health Record Review
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Interview
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Choice of TXT-Chatbot
Description
The choice of implementation approaches will be summarized using percentages. Multivariable logistic regression analysis will be performed to explore the relationship between the choice of approaches and age, gender, etc.
Time Frame
Up to 6 months
Title
Number of completed electronic Patient-Reported Outcome (ePRO) responses
Description
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 versus Caucasian) and implementation approaches.
Time Frame
Up to 6 months
Secondary Outcome Measure Information:
Title
Overall Satisfaction Scores Using the Client Satisfaction Questionnaire (CSQ-8)
Description
Participants will complete the Client Satisfaction Questionnaire (CSQ-8), a validated measure that elicits the client's perspective on the value of services received. The 8 items are rated on a 1-5 scale with higher scores indicating greater satisfaction. The overall satisfaction score will be summarized using means and standard deviations across the 8 items. The dichotomized satisfaction score (overall score ≥ 3.5) will be summarized using percentages . Multivariable (non-)linear and logistic regression models will be performed to explore the relationship between the endpoints and implementation approaches, age, gender, and other measures.
Time Frame
At 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kuang-Yi Wen, PhD
Phone
215-503-4623
Email
Kuang-Yi.Wen@Jefferson.edu
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuang-Yi Wen, MD
Phone
215-503-4623
Email
Kuang-Yi.Wen@Jefferson.edu

12. IPD Sharing Statement

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

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