Quality of Life of Patients With Desmoid-type Fibromatosis (QUALIFIED)

Erasmus University

Status

Completed

Conditions

Desmoid Tumor

Desmoid-type Fibromatosis

Treatments

Other: Questionnaires

Study type

Observational

Funder types

Other

Identifiers

NCT04289077

MEC-2019-0816

Details and patient eligibility

About

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.

Full description

Objectives: The primary objective is to evaluate HRQoL problems in adult DTF patients. The secondary objectives are: 1) to compare the level of HRQoL of DTF patients to the general population, 2) to identify patient subgroups who are at risk for developing certain HRQoL problems, 3) to evaluate patient preferences regarding their health care needs for DTF.

Outline: All patients, aged above 18 years, with a histopathological proved DTF tumour and sufficient Dutch language skills who have received their last check-up in the hospital within the last five years (April 2014). Patients treated in one of the participating centres, will be asked to fill out a set of questionnaires (baseline questionnaire, health care utilization, decision making, EORTC QLQ-C30, DTF-specific questionnaire, and the EQ-5D-5L). Patients will only have to fill out these questionnaires once.

Enrollment

156 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Familial adenomatous polyposis (FAP)