Clinical trial · Observational
Feasibility Study of an ePRO Monitoring for Patients With Multiple Myeloma and Development of Item Lists
Feasibility Study of a Electronic Patient-Reported Outcome (ePRO) Monitoring for Patients With Multiple Myeloma and Development and Evaluation of Treatment-specific Item Lists
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Multiple Myeloma | Multiple Myeloma | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Weekly questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with multiple myeloma
- interventionNames
- Behavioral: Weekly questionnaires
Primary outcomes (2)
- measure
- Patient rated feasibility and adequacy of the item lists and symptom monitoring program
- timeFrame
- 6 weeks after inclusion of the patient or after the patient used the portal 3 times, whichever came first
- description
- 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
- measure
- Assessment completion rate
- timeFrame
- 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
- description
- Calculated as the number of completed assessments divided by the number of expected assessments.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLehmann J, de Ligt KM, Tipelius S, Giesinger JM, Sztankay M, Voigt S, van de Poll-Franse LV, Rumpold G, Weger R, Willenbacher E, Willenbacher W, Holzner B. Adherence to Patient-Reported Symptom Monitoring and Subsequent Clinical Interventions for Patients With Multiple Myeloma in Outpatient Care: Longitudinal Observational Study. J Med Internet Res. 2023 Aug 22;25:e46017. doi: 10.2196/46017. PMID 37606979