PROSa Desmoid
Burden of Disease and Living Situation in Desmoid Patients
Rekrutierend
NCT-Nummer:
NCT06258421
Studienbeginn:
Oktober 2023
Letztes Update:
14.02.2024
Wirkstoff:
-
Indikation (Clinical Trials):
Fibromatosis, Aggressive
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
Technische Universität Dresden
Collaborator:
SOS Desmoid e.V., Universitätsmedizin Mannheim,
Studienleiter
Martin Eichler, Dr., M.Sc. / PHD
Principal Investigator
Universitätsklinikum Carl-Gustav-Carus Dresden
Kontakt
Rebekka Hoffmann, M.Sc. Psychology
Kontakt:
Phone: +4935145813546
E-Mail: rebekka.hoffmann@ukdd.de» Kontaktdaten anzeigen
Martin Eichler, Dr., PHD
Kontakt:
Phone: +4935145819057
E-Mail: martin.eichler@ukdd.de» Kontaktdaten anzeigen
Brief Summary:
The main aim of the study is to assess the situation and quality of life of desmoid patients.
Impaired areas of quality of life and the associated factors are to be identified. The survey
is planned as a cross-sectional study (patient survey).
Prevalent and incident desmoid patients will be identified at the University Hospital
Mannheim and checked for eligibility. Quality of life and patient-reported data are collected
by means of written questionnaires. Medical data is collected from patient files in the
clinics. The aim is to include 100 patients. Descriptive analyses of the variables collected
and regression models are planned as statistical analysis.
Inclusion Criteria:
- Desmoid diagnosis (primary neoplasia, all stages)
- Age ≥18 years at diagnosis
Exclusion Criteria:
- Inability to complete a structured questionnaire (insufficient language skills;
dementia)
Primary outcome:
1. Health-related Quality of Life (EORTC C30) (Time Frame - baseline):
Health-Related Quality of Life Questionnaire
Secondary outcome:
1. The Brief Pain Inventory (BPI) (Time Frame - baseline):
The BPI scale defines pain as follows: Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain.
2. Reintegration to Normal Living (RNL) Index (Time Frame - baseline):
Reintegration to normal living as a proxy to quality of life
3. Supportive Care Needs Survey (Time Frame - baseline)
- No Intervention:
Observatory Study
Quelle: ClinicalTrials.gov
Sie können folgenden Inhalt einem Kollegen empfehlen:
"Burden of Disease and Living Situation in Desmoid Patients"
Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.
Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!
