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Quality of Life in Patients With Multiple Myeloma-validation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03537222
Recruitment Status : Recruiting
First Posted : May 25, 2018
Last Update Posted : August 14, 2019
Sponsor:
Collaborators:
Kantonsspital Münsterlingen
Kantonsspital Aarau
Klinik Hirslanden, Zurich
Celgene Corporation
King's College London
Information provided by (Responsible Party):
Prof. Dr. med. Julia Dratva, Zurich University of Applied Sciences

Brief 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.

Condition or disease Intervention/treatment
Multiple Myeloma Diagnostic Test: Myeloma Patient Outcome Scale (MyPOS)

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.

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Study Type : Observational
Estimated Enrollment : 210 participants
Observational Model: Other
Time Perspective: Cross-Sectional
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
Actual Study Start Date : October 10, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Multiple Myeloma

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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with multiple myeloma
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03537222


Contacts
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Contact: Julia Dratva, Prof.Dr.med. +41 58 934 63 72 julia.dratva@zhaw.ch
Contact: Szilvia Altwicker, Dr. +41 58 934 63 41 szilvia.altwicker-hamori@zhaw.ch

Locations
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Switzerland
Kantonsspital Münsterlingen Recruiting
Münsterlingen, Thurgau, Switzerland, 8596
Principal Investigator: Christian Taverna, Dr.med         
Kantonsspital Aarau Not yet recruiting
Aarau, Zurich, Switzerland, 5001
Principal Investigator: Mario Bargetzi, Prof. Dr.         
Onkozentrum Hirslanden Not yet recruiting
Zurich, Switzerland, 8032
Principal Investigator: Christoph Renner, Prof. Dr.         
Sponsors and Collaborators
Zurich University of Applied Sciences
Kantonsspital Münsterlingen
Kantonsspital Aarau
Klinik Hirslanden, Zurich
Celgene Corporation
King's College London
Investigators
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Principal Investigator: Julia Dratva, Prof.Dr.med Zurich University of Applied Sciences
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Responsible Party: Prof. Dr. med. Julia Dratva, Head of health sciences research unit, Zurich University of Applied Sciences
ClinicalTrials.gov Identifier: NCT03537222    
Other Study ID Numbers: 97107155001701
First Posted: May 25, 2018    Key Record Dates
Last Update Posted: August 14, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. med. Julia Dratva, Zurich University of Applied Sciences:
quality of life
psychometrics
Additional relevant MeSH terms:
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Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases