Burden of Disease and Living Situation in Desmoid Patients

NCT06258421 | Completed

• 1 other identifier: SR+BO-EK-388092023
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Desmoid Tumor; Quality of Life

Keywords

Health-related Quality of Life; Unmet needs; Return to normal life

Outcome Measures

Primary Outcomes (1)

• Health-related Quality of Life (EORTC C30)

  Health-Related Quality of Life Questionnaire

  baseline

Secondary Outcomes (3)

• The Brief Pain Inventory (BPI)

  baseline

• Reintegration to Normal Living (RNL) Index

  baseline

• Supportive Care Needs Survey

  baseline

Study Arms (1)

Desmoid Tumor Patients

People who have been diagnosed with a desmoid tumor after the age of 18

Other: No Intervention

Interventions

No Intervention OTHER

Observatory Study

Desmoid Tumor Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

People who have been diagnosed with a desmoid tumorafter the age of 18. Treatment at the Mannheim University Hospital or via SOS Desmoid e.V.

You may qualify if:

• Desmoid diagnosis (primary neoplasia, all stages)
• Age ≥18 years at diagnosis

You may not qualify if:

• Inability to complete a structured questionnaire (insufficient language skills; dementia)

Sponsors & Collaborators

• Technische Universität Dresden: lead
• SOS Desmoid e.V.: collaborator
• Universitätsmedizin Mannheim: collaborator

Study Sites (1)

Universitätsklinikum Carl-Gustav-Carus Dresden

Dresden, Saxony, 01307, Germany

Location

MeSH Terms

Conditions

Desmoid Tumors

Condition Hierarchy (Ancestors)

Fibroma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Martin Eichler, Dr., M.Sc. / PHD

  Universitätsklinikum Carl-Gustav-Carus Dresden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 14, 2024
• Study Start: October 1, 2023
• Primary Completion: August 31, 2024
• Study Completion: September 1, 2024
• Last Updated: August 24, 2025

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)