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

Sponsor

Medical University Innsbruck (Other)

Overall Status

Recruiting

CT.gov ID

NCT05036863

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma	Behavioral: Weekly questionnaires

Detailed Description

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 Design

Study Type:

Observational

Anticipated Enrollment :

60 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Jul 1, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Patient rated feasibility and adequacy of the item lists and symptom monitoring program [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
Assessment completion rate [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.

Secondary Outcome Measures

Completeness of questionnaires [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
Frequency of clinical alerts in the system [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

ICF 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