Quality of Life in Patients With Multiple Myeloma-validation Study

Sponsor

Zurich University of Applied Sciences (Other)

Overall Status

Terminated

CT.gov ID

NCT03537222

Collaborator

Kantonsspital Münsterlingen (Other), Kantonsspital Aarau (Other), Klinik Hirslanden, Zurich (Other), Celgene Corporation (Industry), King's College London (Other)

Enrollment

Locations

33.7

Actual Duration (Months)

19.3

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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.

Study Design

Study Type:

Observational

Actual Enrollment :

58 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 :

Oct 10, 2018

Actual Primary Completion Date :

Jul 31, 2021

Actual Study Completion Date :

Jul 31, 2021

Arms and Interventions

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

Arm

Intervention/Treatment

MyPOS

Diagnostic Test: Myeloma Patient Outcome Scale (MyPOS)

Patients complete the MyPOS questionnaire on quality of life

Outcome Measures

Primary Outcome Measures

Psychometric properties of the culturally-adapted Swiss-German Myeloma Patient Outcome Scale (MyPOS) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kantonsspital Münsterlingen	Münsterlingen	Thurgau	Switzerland	8596
2	Kantonsspital Aarau	Aarau	Zurich	Switzerland	5001
3	Onkozentrum Hirslanden	Zurich		Switzerland	8032

Sponsors and Collaborators

Zurich University of Applied Sciences
Kantonsspital Münsterlingen
Kantonsspital Aarau
Klinik Hirslanden, Zurich
Celgene Corporation
King's College London

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

Last Update Posted:

Oct 14, 2021

Last Verified:

Oct 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Prof. Dr. med. Julia Dratva, Head of health sciences research unit, Zurich University of Applied Sciences

quality of life

psychometrics

Additional relevant MeSH terms:

Multiple Myeloma

Neoplasms, Plasma Cell

Study Results

No Results Posted as of Oct 14, 2021