Individualised Endometrial Cancer Risk Stratification by Bayesian Prediction Model (ENDORISK), Optimizing Clinical Implementation
- Conditions
- Endometrial Cancer
- Registration Number
- NCT07200466
- Lead Sponsor
- Radboud University Medical Center
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 735
- Diagnosed with early stage (FIGO stage I-II) endometrial carcinoma (every grade permitted)
- Eligible for primary surgical treatment (neo-adjuvant therapy is permitted)
- Unable to give informed consent
- No understanding of Dutch language
- Rare types of endometrial cancer, such as endometrial stroma cell sarcoma
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Proportion of patients who decide to have lymph node status assessed in ENDORISK care compared to standard care. from enrolment to surgery Proportion of patients with lymph node metastases within patients undergoing lymph node staging (the positive predictive value) in ENDORISK care 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. 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
- Secondary Outcome Measures
Name Time Method 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 as measured by questionnaire: EORTC Quality of life questionnaire (QLQ) -C30
Health-related quality of life (HRQoL) compared to standard care 12 months after primary surgery as measured by questionnaire: EORTC QLQ-C30
Treatment-related morbidity compared to standard care 12 weeks after primary surgery As measured by questionnaire: EORTC QLQ- Endometrial cancer (EN) 24
Treatment related morbidity compared to standard care 12 months after primary surgery As measured by questionnaire: EORTC QLQ-EN24 and questionnaires about lymphoedema: EORTC IL76 \& Lymphoedema quality of Life (LYMQOL)
Clinicians' experiences with ENDORISK care Within 1 year of start of the inclusion period in their hospital. In depth interviews with a sample of participating clinicians to evaluate user experiences.
Impact of ENDORISK on regional care costs from enrolment to the end of inclusions
Trial Locations
- Locations (14)
Rijnstate
🇳🇱Arnhem, Gelderland, Netherlands
Slingeland Hospital
🇳🇱Doetinchem, Gelderland, Netherlands
Gelderse Vallei
🇳🇱Ede, Gelderland, Netherlands
Radboudumc
🇳🇱Nijmegen, Gelderland, Netherlands
Canisius Wilhelmina Ziekenhuis (CWZ)
🇳🇱Nijmegen, Gelderland, Netherlands
Streekziekenhuis Koningin Beatrix
🇳🇱Winterswijk, Gelderland, Netherlands
Jeroen Bosch Hospital
🇳🇱's-Hertogenbosch, North Brabant, Netherlands
Amphia
🇳🇱Breda, North Brabant, Netherlands
Catharina Hospital
🇳🇱Eindhoven, North Brabant, Netherlands
St. Anna Hospital
🇳🇱Geldrop, North Brabant, Netherlands
Scroll for more (4 remaining)Rijnstate🇳🇱Arnhem, Gelderland, NetherlandsTijmen Bonestroo, MD PhDPrincipal Investigator