Burden of Disease and Living Situation in Desmoid Patients (PROSa Desmoid)

February 13, 2024 updated by: Technische Universität Dresden

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Germany
    • Saxony
      • Dresden, Saxony, Germany, 01307
        • Recruiting
        • Universitätsklinikum Carl-Gustav-Carus Dresden
        • Contact:
        • Principal Investigator:
          • Martin Eichler, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Desmoid Tumor Patients
People who have been diagnosed with a desmoid tumor after the age of 18
Other: No Intervention
Observatory Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related Quality of Life (EORTC C30)
Time Frame: baseline
Health-Related Quality of Life Questionnaire
baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
baseline
Reintegration to Normal Living (RNL) Index
Time Frame: baseline
Reintegration to normal living as a proxy to quality of life
baseline
Supportive Care Needs Survey
Time Frame: baseline
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Technische Universität Dresden

Collaborators

Universitätsmedizin Mannheim
SOS Desmoid e.V.

Investigators

  • Principal Investigator: Martin Eichler, Dr., M.Sc. / PHD, Universitätsklinikum Carl-Gustav-Carus Dresden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

January 24, 2024

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Actual)

February 14, 2024

Study Record Updates

Last Update Posted (Actual)

February 14, 2024

Last Update Submitted That Met QC Criteria

February 13, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SR+BO-EK-388092023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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