Quality of Life in Patients With Multiple Myeloma-validation Study

October 5, 2021 updated by: Prof. Dr. med. Julia Dratva, Zurich University of Applied Sciences

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

58

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8032
        • Onkozentrum Hirslanden
    • Thurgau
      • Münsterlingen, Thurgau, Switzerland, 8596
        • Kantonsspital Münsterlingen
    • Zurich
      • Aarau, Zurich, Switzerland, 5001
        • Kantonsspital Aarau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with multiple myeloma

Description

Inclusion Criteria:

  • informed consent as documented by signature
  • confirmed histological diagnosis of multiple myeloma,
  • age ≥ 18 years,
  • mental capacity to give written informed consent

Exclusion Criteria:

  • inability to communicate in German
  • participation in another clinical study
  • more than one cancer diagnosis
  • mental illness (i.e. psychiatric diagnosis)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MyPOS
Diagnostic test: Myeloma Patient Outcome Scale (MyPOS)
Patients complete the MyPOS questionnaire on quality of life

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
upon enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zurich University of Applied Sciences

Collaborators

King's College London
Celgene Corporation
Kantonsspital Aarau
Klinik Hirslanden, Zurich
Kantonsspital Münsterlingen

Investigators

  • Principal Investigator: Julia Dratva, Prof.Dr.med, Zurich University of Applied Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 10, 2018

Primary Completion (ACTUAL)

July 31, 2021

Study Completion (ACTUAL)

July 31, 2021

Study Registration Dates

First Submitted

May 15, 2018

First Submitted That Met QC Criteria

May 15, 2018

First Posted (ACTUAL)

May 25, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 14, 2021

Last Update Submitted That Met QC Criteria

October 5, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 97107155001701

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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