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Quality of Life of Patients With Desmoid-type Fibromatosis

NCT04289077 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 156

Last updated 2023-09-07

No results posted yet for this study

Summary

Rationale: Desmoid-type fibromatosis (DTF) is a rare, histologically benign, soft tissue tumour. Although incapable of metastasizing, the clinical course is unpredictable and can be aggressive because of local invasive growth. Various treatments are available including; surgical resection, radiotherapy, hormonal therapy and chemotherapy. Nowadays there is a trend towards a more conservative strategy with a wait and see policy because of high recurrence rates after surgical resection. Health-related quality of life (HRQL) is a corner stone in treatment choice and can be used during the disease for monitoring the impact of the disease on physical, psychological and social level. Additionally, HRQL can be in important endpoint for future clinical trials. Today, no HRQL-tools are available which capture the needs of DTF patients. The hypothesis is that patients with DTF have issues on several HRQL domains including physical, social and emotional well-being. For this reason we developed a list of items based on previous research. This study aims to evaluate HRQL issues experienced by DTF patients.

Purpose: Multi-centre, cross-sectional, observational study to measure HRQL of DTF patients and to evaluate the prevalence of the experienced problems.

Conditions

  • Desmoid Tumor
  • Desmoid-type Fibromatosis

Interventions

OTHER

Questionnaires

\- Baseline questionnaire, version 1.0, October 29 2019, (Dutch) - Health care utilization, version 1.0, October 29 2019, (Dutch) - Decision-making, version 1.0, October 29 2019, (Dutch) - EORTC QLQ-C30, version 3.0, (Dutch) - DTF-QoL, version 1.0, October

Sponsors & Collaborators

  • Radboud University Medical Center

    collaborator OTHER

  • The Netherlands Cancer Institute

    collaborator OTHER

  • Royal Marsden NHS Foundation Trust

    collaborator OTHER

  • Erasmus Medical Center

    lead OTHER

Principal Investigators

  • C. Verhoef, MD, PhD · Erasmus Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-06
Primary Completion
2021-02-01
Completion
2021-02-01

Countries

  • Netherlands
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04289077 on ClinicalTrials.gov