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
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 or English language
Rare types of endometrial cancer, such as endometrial stroma cell sarcoma
Single group
ENDORISK personalized risk assesment for lymph node metastases in endometrial cancer.
Diagnostic testThe 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.
Proportion of patients who decide to have lymph node status assessed in ENDORISK care compared to standard care.
Proportion of patients with lymph node metastases within patients undergoing lymph node staging (the positive predictive value) in ENDORISK care
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.
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
Patients' 5-year disease- specific-, overall survival (DSS, OS), compared to standard care;
Health related quality of life (HRQoL) compared to standard care
as measured by questionnaire: EORTC Quality of life questionnaire (QLQ) -C30
Health-related quality of life (HRQoL) compared to standard care
as measured by questionnaire: EORTC QLQ-C30
Treatment-related morbidity compared to standard care
As measured by questionnaire: EORTC QLQ- Endometrial cancer (EN) 24
Charlson-index
Charlson-index as reported by participants and as reported by clinician/researcher from patient records
Health literacy
Health Literacy as reported by participants through a questionnaire
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Radboud University Medical Center
Lead sponsor
Elisabeth-TweeSteden Ziekenhuis
Collaborator
Amphia Hospital
Collaborator
Catharina Ziekenhuis Eindhoven
Collaborator
Elkerliek Hospital
Collaborator
St. Anna Ziekenhuis, Geldrop, Netherlands
Collaborator
Jeroen Bosch Ziekenhuis, s'-Hertogenbosch
Collaborator
Rijnstate Hospital
Collaborator
Canisius-Wilhelmina Hospital
Collaborator
Maxima Medical Center
Collaborator
Bernhoven Hospital
Collaborator
Maas Hospital Pantein
Collaborator
Slingeland Hospital
Collaborator
Streekziekenhuis Koningin Beatrix
Collaborator
Gelderse Vallei Hospital
Collaborator
Comprehensive Cancer Centre The Netherlands
Collaborator
Stichting PAMM
Collaborator
