Burden of Disease and Living Situation in Desmoid Patients

Quality of Life Clinical Trial

— PROSa Desmoid  

Official title:

Burden of Disease and Living Situation in Desmoid Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06258421
• Other study ID #: SR+BO-EK-388092023
• Status: Recruiting
• Start date: October 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Technische Universität Dresden
• Contact: Rebekka Hoffmann, M.Sc. Psychology
• Phone: +4935145813546
• Email: rebekka.hoffmann[@]ukdd.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Desmoid Tumor
• Quality of Life

Intervention

Other:
• No Intervention
Observatory Study

Locations

Country	Name	City	State
Germany	Universitätsklinikum Carl-Gustav-Carus Dresden	Dresden	Saxony

Sponsors (3)

Lead Sponsor	Collaborator
Technische Universität Dresden	SOS Desmoid e.V., Universitätsmedizin Mannheim

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related Quality of Life (EORTC C30)	Health-Related Quality of Life Questionnaire	baseline
Secondary	The Brief Pain Inventory (BPI)	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.	baseline
Secondary	Reintegration to Normal Living (RNL) Index	Reintegration to normal living as a proxy to quality of life	baseline
Secondary	Supportive Care Needs Survey		baseline