Feasibility Study of an ePRO Monitoring for Patients With Multiple Myeloma and Development of Item Lists

September 16, 2022 updated by: Medical University Innsbruck

Feasibility Study of a Electronic Patient-Reported Outcome (ePRO) Monitoring for Patients With Multiple Myeloma and Development and Evaluation of Treatment-specific Item Lists

The trial is a feasibility study of a patient-reported outcome (PRO) monitoring for patients with multiple myeloma. Patients will report weekly PROs during treatment at our outpatient unit. The trial will describe the development of treatment-specific item lists to adequately capture relevant symptoms during therapy, evaluate the feasibility of the weekly symptom monitoring, and evaluate the healthcare professional usage of the system in clinical practice.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The trial is a feasibility study of a patient-reported outcome (PRO) monitoring for patients with multiple myeloma. Patients will report weekly PROs during treatment at our outpatient unit. The trial will describe the development of treatment-specific item lists to adequately capture relevant symptoms during therapy, evaluate the feasibility of the weekly symptom monitoring, and evaluate the healthcare professional usage of the system in clinical practice.

The item lists will supplement an already established patient-reported outcome measure (PROM) implementation for the Austrian Myeloma Registry (AMR) at the Department of Hematology in Innsbruck. For the development of the treatment-specific item lists, a review of the literature for symptoms reported in clinical trials of the respective treatment regimens will be conducted. Then, a consensus panel of multiple stakeholders will discuss the symptoms and relevant issues for each treatment group. In an iterative process, the item lists will be developed to capture the most relevant and clinically important symptoms during active therapy to maximize clinical usage.

The observational part of the trial will then test the feasibility of the electronic symptom monitoring and the treatment-specific item lists. Patients will be recruited who are already participating in a routine care patient-reported outcome monitoring. They will be given access to the web-based patient portal and asked to complete weekly assessments using the treatment-specific item lists. In larger intervals (every 6 weeks), they will also be asked to complete a larger questionnaire battery using the EORTC QLQ-C30 and the treatment-specific module (EORTC QLQ-MY20). In the patient portal, patients will also be able to review their own results and receive feedback and self-management advice. Patients will also receive reminders to remind them to use the patient portal.

For healthcare professionals, the system will display the results of the PROMs and trigger alerts if patients reach thresholds for clinical importance. A clinical nurse will monitor the recently completed PROMs and contact patients who exceed the thresholds.

Patients will stay on the symptom monitoring as long as they receive active treatment. They may be excluded if they move to stationary care, depending on their health status or if they want to end the monitoring. The feasibility of the weekly monitoring and items lists will be evaluated and patient feedback to the patient portal and item lists will be recorded and analysed.

Study Type

Observational

Enrollment (Actual)

39

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Hämatologische Ambulanz - Tirol Kliniken

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients with multiple myeloma who meet the inclusion criteria

Description

Inclusion Criteria:

  • Informed consent form signed
  • sufficient language proficiency in German
  • no overt cognitive impairments
  • reporting to use the internet at least once a month
  • able to log into a website using an individualized username and password (tested when patients are introduced to the patient portal)
  • patients are currently receiving active therapy for the treatment of their multiple myeloma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with multiple myeloma
Behavioral: Weekly questionnaires
Patients will complete weekly symptom monitoring PROMs. If a symptom exceeds the thresholds for clinical importance, a registered nurse will contact the patient, confirm the symptoms and coordinate the further clinical procedure in line with standard practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient rated feasibility and adequacy of the item lists and symptom monitoring program
Time Frame: 6 weeks after inclusion of the patient or after the patient used the portal 3 times, whichever came first
assessed via a questionnaire, after six weeks in the program or after using the portal 3 times (whichever occurs first); ratings are provided on a 1 to 4 scale ("not at all" to "very much", higher scores are better); the evaluation questionnaire was created for the study
6 weeks after inclusion of the patient or after the patient used the portal 3 times, whichever came first
Assessment completion rate
Time Frame: From the inclusion of the patient until the end of the study (ie, at maximum 12 months) or until the patient withdraws, whichever came first
Calculated as the number of completed assessments divided by the number of expected assessments.
From the inclusion of the patient until the end of the study (ie, at maximum 12 months) or until the patient withdraws, whichever came first

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completeness of questionnaires
Time Frame: From the inclusion of the patient until the end of the study (ie, at maximum 12 months) or until the patient withdraws, whichever came first
Number of missing items in the symptom item sets
From the inclusion of the patient until the end of the study (ie, at maximum 12 months) or until the patient withdraws, whichever came first
Frequency of clinical alerts in the system
Time Frame: All alerts generated during the study period (ie, at maximum 12 months)
The frequency of clinical alerts in the system (appropriateness of thresholds) and the interventions that were taken in response to the alerts will be investigated
All alerts generated during the study period (ie, at maximum 12 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University Innsbruck

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

June 24, 2021

First Submitted That Met QC Criteria

September 7, 2021

First Posted (Actual)

September 8, 2021

Study Record Updates

Last Update Posted (Actual)

September 19, 2022

Last Update Submitted That Met QC Criteria

September 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SymOn[2021]

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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