The Evaluation of Health-related Quality of Life Issues Experienced by Patients With Desmoid-type Fibromatosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 4
- 主要终点
- EQ-5D-5L questionnaire (EuroQol five-dimensional questionnaire; version 1.0)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Familial adenomatous polyposis (FAP)
结局指标
主要结局
EQ-5D-5L questionnaire (EuroQol five-dimensional questionnaire; version 1.0)
时间窗: 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.
Measures health-related quality of life on five dimensions of health: mobility, self-care, usual activities, pain-discomfort, and anxiety/depression. Additionally two questions aim to rank a patients' health (scale 0-100, with 100 representing a better health). Each of the five dimensions can be divided into five levels of perceived problems: no problems (level 1), slight problems (level 2), moderate problems (level 3), severe problems (level 4) and extreme problems (level). Health states can be converted into single index values. The outcomes will be reported as frequency (proportion) of reported problems for each level and for each dimension. The Visual Analogue Scale (VAS) data will be presented as a mean value (SD). In case of skewed data, median values and IQR will be used.
DTF-QoL questionnaire (Desmoid-type fibromatosis Quality of Life Questionnaire)
时间窗: 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.
The scores for each item of the DTF-QoL will be calculated using a Likert scale from 1-4. The scores of each item will be calculated as mean ± SD, or as median (IQR). These scores (median or mean) will be reported per item.
EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire-Core-30; version 3.0)
时间窗: 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.
Each question will be scored: not at all (1), a little (2), quite a bit (3), very much (4). The scores of the EORTC-QLQ30 will be calculated using a Likert scale from 1-4. The scoring manual of the EORTC will be followed. After linear transformation, all scales and single item measures range in score from 0-100. Scores for each scale will be reported as mean (SD), or as median (IQR). A higher score on the functional scales and global quality of life means better functioning and HRQoL, whereas a higher score on the symptom scales means more complaints. The EORTC QLQ-C30 summary score will be calculated using the mean scores of the function scales and the reversed mean scores of the symptom scales and represented as the mean of the combined 13 QLQ-C30 scale scores (financial impact and global health status excluded). A higher summary score represented a better outcome.
次要结局
- EORTC QLQ-C30 questionnaire (European Organisation for Research and Treatment of Cancer, Quality of Life Questionnaire-Core-30; version 3.0)(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.)
- Baseline questionnaire (version 1.0)(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.)
- Decision making questionnaire (version 1.0)(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.)
- Healt care utilization questionnaire (version 1.0)(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.)
研究者
C. Verhoef
Prof. dr. C. Verhoef, MD, PhD
Erasmus Medical Center