ENDORISK Clinical Implementation Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 735
- 试验地点
- 29
- 主要终点
- Proportion of patients who decide to have lymph node status assessed in ENDORISK care compared to standard care.
研究概览
简要总结
Rationale: Preoperative identification of patients at risk for lymph node metastasis (LNM) is challenging in endometrial cancer (EC). Therefore, a Bayesian network model called ENDORISK was developed and validated in three external cohorts to improve preoperative risk stratification. The next step is to implement and evaluate whether use of the model improves daily clinical practice. Objective: The ENDORISK implementation (ENDORISK-I) study aims to prospectively evaluate whether implementation of ENDORISK in daily clinical practice improves preoperative risk stratification. Study design: A stepped wedge non inferiority study in which two oncology regions will consecutively start implementation of ENDORISK with one year interval. The ENDORISK model will be filled in and used in preoperative treatment counselling. Results will be compared to current standard clinical care which is prospectively evaluated in both regions since March 2022 in the 'evaluation of care in endometrial cancer' study (2021-7400). Study population: all consecutive patients recently diagnosed with early stage EC who are eligible for surgical treatment, who understand Dutch and are able to fill in a digital or paper questionnaire can be included. Main study parameters/endpoints: The ENDORISK implementation (ENDORISK-I) study aims to prospectively evaluate implementation of ENDORISK in daily clinical practice by investigating:
- The proportion of identified LNM in patients with lymph node staging (positive predictive value (PPV)) compared to standard care
- Proportion of patients who decide to have lymph node status assessed in ENDORISK care compared to standard care
- Preoperative information provision for patients and shared-decision making with the use of ENDORISK compared to standard care
- Patients' disease- specific-, overall survival, and health-related quality of life compared to standard care
- Patients' and doctors' use of and experiences with the ENDORISK-model
- Impact of ENDORISK on regional care costs
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with early stage (FIGO stage I-II) endometrial carcinoma (every grade permitted)
- •Eligible for primary surgical treatment (neo-adjuvant therapy is permitted)
排除标准
- •Unable to give informed consent
- •No understanding of Dutch or English language
- •Rare types of endometrial cancer, such as endometrial stroma cell sarcoma
研究组 & 干预措施
Control
The control arm is a group of patients from our previous 'evaluation of care' study which underwent standard care for endometrial cancer between march of 2022 and the start of the ENDORISK-I study. This group serves as a control group for the intervention arm.
Intervention
The intervention group are patients receiving a personalized risk on lymph node metastases as predicted by the ENDORISK model, they also receive a treatment plan (hysterectomy + bilateral salpingo-oophorectomy with or without lymph node surgery) based on this personalized risk.
干预措施: ENDORISK personalized risk assesment for lymph node metastases in endometrial cancer. (Diagnostic Test)
结局指标
主要结局
Proportion of patients who decide to have lymph node status assessed in ENDORISK care compared to standard care.
时间窗: from enrolment to surgery
Proportion of patients with lymph node metastases within patients undergoing lymph node staging (the positive predictive value) in ENDORISK care
时间窗: From enrolment to time of surgery
The lymph node metastases in patients undergoing lymph node staging will be determined by pathology report on the surgical specimen. The positive predicting value will be compared to the positive predictive value of standard care.
Preoperative information provision for patients and shared-decision making with the use of ENDORISK compared to standard care, measured by questionnaires.
时间窗: From enrolment to 12 weeks post-operatively
Information provision score: Questionnaire EORTC Quality of Life Questionnaire (QLQ)-INFO25 with additional questions specific to ENDORISK use. Shared-decision making score: Shared Decision Making Questionnaire SDM-Q-9 with additional questions specific to ENDORISK use
次要结局
- Patients' 5-year disease- specific-, overall survival (DSS, OS), compared to standard care;(from enrolment to 5-year post surgery)
- Health related quality of life (HRQoL) compared to standard care(12 weeks after primary surgery)
- Health-related quality of life (HRQoL) compared to standard care(12 months after primary surgery)
- Treatment-related morbidity compared to standard care(12 weeks after primary surgery)
- Treatment related morbidity compared to standard care(12 months after primary surgery)
- Clinicians' experiences with ENDORISK care(Within 1 year of start of the inclusion period in their hospital.)
- Impact of ENDORISK on regional care costs(from enrolment to the end of inclusions)