NCT03537222

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2018

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 15, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 25, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

October 10, 2018

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2021

Completed
Last Updated

October 14, 2021

Status Verified

October 1, 2021

Enrollment Period

2.8 years

First QC Date

May 15, 2018

Last Update Submit

October 5, 2021

Conditions

Keywords

quality of lifepsychometrics

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

MyPOS

Diagnostic Test: Myeloma Patient Outcome Scale (MyPOS)

Interventions

Patients complete the MyPOS questionnaire on quality of life

MyPOS

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with multiple myeloma

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Kantonsspital Aarau

Aarau, Canton of Zurich, 5001, Switzerland

Location

Kantonsspital Münsterlingen

Münsterlingen, Thurgau, 8596, Switzerland

Location

Onkozentrum Hirslanden

Zurich, 8032, Switzerland

Location

MeSH Terms

Conditions

Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Study Officials

  • Julia Dratva, Prof.Dr.med

    Zurich University of Applied Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of health sciences research unit

Study Record Dates

First Submitted

May 15, 2018

First Posted

May 25, 2018

Study Start

October 10, 2018

Primary Completion

July 31, 2021

Study Completion

July 31, 2021

Last Updated

October 14, 2021

Record last verified: 2021-10

Locations