Clinical trial NCT04289077: Quality of Life of Patients With Desmoid-type Fibromatosis
Official title: The Evaluation of Health-related Quality of Life Issues Experienced by Patients With Desmoid-type Fibromatosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Desmoid Tumor
Desmoid-type Fibromatosis
Keywords: Health-related quality of life
Quality of life
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Radboud University Medical Center
name: The Netherlands Cancer Institute
name: Royal Marsden NHS Foundation Trust
First posted: 2020-02-28
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, aged ≥18 years, diagnosed with a histopathological proven DTF, regardless of disease stage and received treatment(s) who have received their last check-up of their DTF in one of the participating hospitals the hospital between October 2014 and July 2020.

Brief 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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire-Core-30; version 3.0)
timeFrame: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation.
measure: DTF-QoL questionnaire (Desmoid-type fibromatosis Quality of Life Questionnaire)
timeFrame: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation.
measure: EQ-5D-5L questionnaire (EuroQol five-dimensional questionnaire; version 1.0)
timeFrame: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation.
Secondary outcomes:
measure: EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire-Core-30; version 3.0)
timeFrame: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation.
measure: Baseline questionnaire (version 1.0)
timeFrame: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation.
measure: Healt care utilization questionnaire (version 1.0)
timeFrame: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation.
measure: Decision making questionnaire (version 1.0)
timeFrame: Participants have to fill out the questionnaire once and have to complete the questionnaire within 3 months after the invitation. A reminder for participation will be send one month after the initial invitation.
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: 3. Antoni van Leeuwenhoek Ziekenhuis (AVL) / The Netherlands Cancer Instituut , Amsterdam, The Netherlands
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center (MC), Nijmegen, The Netherlands
city: Rotterdam
country: Netherlands
facility: Erasmus MC Cancer Institute
city: London
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust
Study officials:
affiliation: Erasmus Medical Center
name: C. Verhoef, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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