Burden of Disease and Living Situation in Desmoid Patients

Recruiting

• Conditions: Desmoid Tumor; Quality of Life
• Interventions: Other: No Intervention

• Registration Number: NCT06258421
• Lead Sponsor: Technische Universität Dresden

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-01
• Study First Submitted: 2024-01-24
• Status Verified: 2024-02
• Primary Completion: 2024-02
• Study First Submitted QC: 2024-02-13
• Last Update Submitted: 2024-02-13
• Study First Posted: 2024-02-14
• Last Update Posted: 2024-02-14
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Desmoid Tumor Patients	No Intervention	People who have been diagnosed with a desmoid tumor after the age of 18

Primary Outcome Measures

Name	Time	Method
Health-related Quality of Life (EORTC C30)	baseline	Health-Related Quality of Life Questionnaire

Secondary Outcome Measures

Name	Time	Method
The Brief Pain Inventory (BPI)	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.
Reintegration to Normal Living (RNL) Index	baseline	Reintegration to normal living as a proxy to quality of life
Supportive Care Needs Survey	baseline

Trial Locations

Locations (1)

Universitätsklinikum Carl-Gustav-Carus Dresden; 🇩🇪 Dresden, Saxony, Germany