Multiple MyelomaNCT05036863
Feasibility Study of an ePRO Monitoring for Patients With Multiple Myeloma and Development of Item Lists
An observational study of Multiple Myeloma, run by Medical University Innsbruck at 1 site in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Myeloma
- What is being tested?
- Weekly questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 39 participants
- Where
- 1 siteAustria
- Study dates
- 1 Jul 2021to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All patients with multiple myeloma who meet the inclusion criteria
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Multiple Myeloma
- Being tested
- Weekly questionnaires
- Keywords
- Patient reported outcomes, Symptom monitoring, Follow-up, Multiple Myeloma
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly questionnairesBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with multiple myeloma | Not described Receives: Behavioral: Weekly questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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
Number of missing items in the symptom item sets
Measured: 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
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
Measured: All alerts generated during the study period (ie, at maximum 12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2021
- Study start1 Jul 2021
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- More trials run by Medical University InnsbruckThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05036863
- Sponsor's protocol ID
- SymOn[2021]
- Status last verified
- Aug 2022
- First submitted
- 24 Jun 2021
- Last updated
- 19 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37606979
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05036863
- Acronym / sponsor ID
- SymOn[2021]
- Conditions
- Multiple Myeloma
- Keywords
- Patient reported outcomes, Symptom monitoring, Follow-up, Multiple Myeloma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 8 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with multiple myeloma | – | Behavioral: Weekly questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients with multiple myeloma who meet the inclusion criteria
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Weekly questionnairesPatients 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. | Behavioural | Patients with multiple myeloma |
Primary outcome
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
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.
2 secondary outcomes
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
Frequency of clinical alerts in the system
Time frame: All alerts generated during the study period (ie, at maximum 12 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2022.
- Derived from this study: PubMed 37606979Lehmann 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.
- Individual participant dataSharing planned: No
Related trials for Multiple Myeloma
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Myeloma, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05036863, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2022.