Quality of Life in Patients With Multiple Myeloma-validation Study

Multiple Myeloma Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03537222
• Other study ID #: 97107155001701
• Status: Terminated
• Start date: October 10, 2018
• Est. completion date: July 31, 2021

Study information

• Verified date: October 2021
• Source: Zurich University of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: July 31, 2021
• Est. primary completion date: July 31, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Myeloma
• Neoplasms, Plasma Cell

Intervention

Diagnostic Test:
• Myeloma Patient Outcome Scale (MyPOS)
Patients complete the MyPOS questionnaire on quality of life

Locations

Country	Name	City	State
Switzerland	Kantonsspital Aarau	Aarau	Zurich
Switzerland	Kantonsspital Münsterlingen	Münsterlingen	Thurgau
Switzerland	Onkozentrum Hirslanden	Zurich

Sponsors (6)

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

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	upon enrollment