Multiple MyelomaNCT03537222
Quality of Life in Patients With Multiple Myeloma-validation Study
An observational study of Multiple Myeloma, run by Zurich University of Applied Sciences at 3 sites in Switzerland.
Trial summary
In this study, the Myeloma Patient Outcome Scale (MyPOS) will be translated from English to German. This translated version will be quantitatively and qualitatively validated with patients with multiple myeloma. 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?
- Myeloma Patient Outcome Scale (MyPOS)
- How many people
- 58 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 10 Oct 2018to 31 Jul 2021
- 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: Patients with multiple myeloma
Who may be able to join
- informed consent as documented by signature
- confirmed histological diagnosis of multiple myeloma,
- age ≥ 18 years,
- mental capacity to give written informed consent
Who cannot join
- inability to communicate in German
- participation in another clinical study
- more than one cancer diagnosis
- mental illness (i.e. psychiatric diagnosis)
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Kantonsspital Aarau
Aarau, Canton of Zurich, 5001
Kantonsspital Münsterlingen
Münsterlingen, Thurgau, 8596
Onkozentrum Hirslanden
Zurich, 8032
About this study
Official title: Validation of the Myeloma Patient Outcome Scale (MyPOS) Assessing the Quality of Life in Patients With Multiple Myeloma in the German Speaking Part of Switzerland
In this study, the Myeloma Patient Outcome Scale (MyPOS) will be translated from English to German. This translated version will be quantitatively and qualitatively validated with patients with multiple myeloma.
Read the detailed description
Patients with multiple myeloma (N=10) will be interviewed in the qualitative phase about their comprehension of the translated MyPOS. The questionnaire will be revised according to the results of the interviews. This culturally adapted Swiss-German MyPOS will be assessed in the quantitative phase for its' psychometric properties with 200 patients with multiple myeloma.
- Conditions
- Multiple Myeloma
- Being tested
- Myeloma Patient Outcome Scale (MyPOS)
- Keywords
- quality of life, psychometrics
- Medical subject headings
- Multiple Myeloma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Myeloma Patient Outcome Scale (MyPOS)Diagnostic test
Patients complete the MyPOS questionnaire on quality of life
| Study group | Role | What they receive |
|---|---|---|
| MyPOS | Not described Receives: Diagnostic Test: Myeloma Patient Outcome Scale (MyPOS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychometric properties of the culturally-adapted Swiss-German Myeloma Patient Outcome Scale (MyPOS)
The primary outcome will be the scores on each item of the culturally-adapted Swiss-German MyPOS. Items are scored on a five-point Likert scale. For the analysis, the three subscales "Symptoms" (range: 0-52), "Emotions" (range:0-68) and "Healthcare Support" (range: 0-12) are assessed as well as the MyPOS total score (range: 0-132 ) by summing up the item scores ranging from 0-4. Higher scores reflect worse quality of life.
The scores will be used to evaluate the psychometric properties of the culturally-adapted Swiss-German MyPOS:
- Structural validity,
- Internal consistency,
- Construct validity,
- Convergent and divergent validity.
Measured: upon enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2018
- Study start10 Oct 2018
- Primary completion31 Jul 2021
- Study completion31 Jul 2021
Why it stopped: Not enough participants and study funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple MyelomaStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zurich University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Kantonsspital Münsterlingen, Kantonsspital Aarau, Klinik Hirslanden, Zurich, Celgene Corporation, King's College London
- Responsible party
- Principal investigator, Prof. Dr. med. Julia Dratva, Zurich University of Applied Sciences
- Investigators
- Julia Dratva, Prof.Dr.med, Principal investigator, Zurich University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03537222
- Sponsor's protocol ID
- 97107155001701
- Status last verified
- Oct 2021
- First submitted
- 15 May 2018
- Last updated
- 14 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Myeloma Patient Outcome Scale (MyPOS) Assessing the Quality of Life in Patients With Multiple Myeloma in the German Speaking Part of Switzerland
- ClinicalTrials.gov ID
- NCT03537222
- Acronym / sponsor ID
- 97107155001701
- Conditions
- Multiple Myeloma
- Keywords
- quality of life, psychometrics
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not enough participants and study funding
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Zurich University of Applied SciencesUniversity, hospital or other
- Collaborators
- Kantonsspital Münsterlingen, Kantonsspital Aarau, Klinik Hirslanden, Zurich, Celgene Corporation, King's College London
- Study start
- 10 Oct 2018 (actual)
- Primary completion
- 31 Jul 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 25 May 2018 (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.
In this study, the Myeloma Patient Outcome Scale (MyPOS) will be translated from English to German. This translated version will be quantitatively and qualitatively validated with patients with multiple myeloma.
Detailed description
Patients with multiple myeloma (N=10) will be interviewed in the qualitative phase about their comprehension of the translated MyPOS. The questionnaire will be revised according to the results of the interviews. This culturally adapted Swiss-German MyPOS will be assessed in the quantitative phase for its' psychometric properties with 200 patients with multiple myeloma.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MyPOS | – | Diagnostic Test: Myeloma Patient Outcome Scale (MyPOS) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with multiple myeloma
Key inclusion criteria (4 listed)
- informed consent as documented by signature
- confirmed histological diagnosis of multiple myeloma,
- age ≥ 18 years,
- mental capacity to give written informed consent
Key exclusion criteria (4 listed)
- inability to communicate in German
- participation in another clinical study
- more than one cancer diagnosis
- mental illness (i.e. psychiatric diagnosis)
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 |
|---|---|---|
| Myeloma Patient Outcome Scale (MyPOS)Patients complete the MyPOS questionnaire on quality of life | Diagnostic test | MyPOS |
Primary outcome
Psychometric properties of the culturally-adapted Swiss-German Myeloma Patient Outcome Scale (MyPOS)
Time frame: upon enrollment
The primary outcome will be the scores on each item of the culturally-adapted Swiss-German MyPOS. Items are scored on a five-point Likert scale. For the analysis, the three subscales "Symptoms" (range: 0-52), "Emotions" (range:0-68) and "Healthcare Support" (range: 0-12) are assessed as well as the MyPOS total score (range: 0-132 ) by summing up the item scores ranging from 0-4. Higher scores reflect worse quality of life. The scores will be used to evaluate the psychometric properties of the culturally-adapted Swiss-German MyPOS: * Structural validity, * Internal consistency, * Construct validity, * Convergent and divergent validity.
Results and safety
The study was stopped early (reason given: Not enough participants and study funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
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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.
Julia Dratva, Prof.Dr.med principal investigator
Zurich University of Applied Sciences
3 sites 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 Zurich University of Applied Sciences at 3 sites in Switzerland.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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 was stopped early (reason given: Not enough participants and study funding). Results are not available in the source record.
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?
Psychometric properties of the culturally-adapted Swiss-German Myeloma Patient Outcome Scale (MyPOS) (time frame: upon enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2021.