NCT05036863

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 8, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

September 19, 2022

Status Verified

August 1, 2022

Enrollment Period

12 months

First QC Date

June 24, 2021

Last Update Submit

September 16, 2022

Conditions

Multiple Myeloma

Keywords

Patient reported outcomesSymptom monitoringFollow-upMultiple Myeloma

Outcome Measures

Primary Outcomes (2)

  • Patient rated feasibility and adequacy of the item lists and symptom monitoring program

    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

    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 Outcomes (2)

  • 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

  • Frequency of clinical alerts in the system

    All alerts generated during the study period (ie, at maximum 12 months)

Study Arms (1)

Patients with multiple myeloma

Behavioral: Weekly questionnaires

Interventions

Weekly questionnairesBEHAVIORAL

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.

Patients with multiple myeloma

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients with multiple myeloma who meet the inclusion criteria

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hämatologische Ambulanz - Tirol Kliniken

Innsbruck, Tyrol, 6020, Austria

Location

Related Publications (1)

  • Lehmann 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: 37606979DERIVED

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2021

First Posted

September 8, 2021

Study Start

July 1, 2021

Primary Completion

June 30, 2022

Study Completion

June 30, 2022

Last Updated

September 19, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)