The Evaluation of Health-related Quality of Life Issues Experienced by Patients With Desmoid-type Fibromatosis

Status: Enrolling by invitation
Location: See all (4) locations...
Intervention Type: Other
Study Type: Observational

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.

Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: No

• Aged 18 years and older

• Histopathological proven DTF, regardless of disease stage or treatment.

• Diagnosed between January 1990 and July 2020, with a visit to the hospital for their DTF (between October 2014 and July 2020)

• Sufficient Dutch language skills

• Competent to complete a questionnaire

• Written informed consent

Other Locations
3. Antoni van Leeuwenhoek Ziekenhuis (AVL) / The Netherlands Cancer Instituut , Amsterdam, The Netherlands
Radboud University Medical Center (MC), Nijmegen, The Netherlands
Erasmus MC Cancer Institute
United Kingdom
Royal Marsden NHS Foundation Trust
Time Frame
Start Date: August 6, 2020
Estimated Completion Date: May 1, 2021
Target number of participants: 156
Patients with histopathological proven DTF
C. Verhoef
Related Therapeutic Areas
Collaborators: The Netherlands Cancer Institute, Royal Marsden NHS Foundation Trust, Radboud University Medical Center
Leads: Erasmus Medical Center

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