NCT Number: NCT07200466
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
Interested in participating?
Request Info45 year and older
Female
Interventional
Not applicable
Rijnstate, Arnhem, Gelderland, Netherlands
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: from enrolment to surgery
Time frame: 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.
Time frame: 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
Time frame: from enrolment to 5-year post surgery
Time frame: 12 weeks after primary surgery
as measured by questionnaire: EORTC Quality of life questionnaire (QLQ) -C30
Time frame: 12 months after primary surgery
as measured by questionnaire: EORTC QLQ-C30
Time frame: 12 weeks after primary surgery
As measured by questionnaire: EORTC QLQ- Endometrial cancer (EN) 24
Time frame: 12 months after primary surgery
As measured by questionnaire: EORTC QLQ-EN24 and questionnaires about lymphoedema: EORTC IL76 & Lymphoedema quality of Life (LYMQOL)
Time frame: at baseline
Questionnaire at baseline
Time frame: 9 months after start of inclusions
Questionnaire at 9 months
Time frame: 18 months after start of inclusions
Questionnaire at 18 months
Time frame: 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.
Time frame: from enrolment to the end of inclusions
Time frame: 12 weeks after primary surgery
Charlson-index as reported by participants and as reported by clinician/researcher from patient records
Time frame: 12 weeks after primary surgery
Health Literacy as reported by participants through a questionnaire
Contact information is provided by the study sponsor or research team.
Hanny M.A. Pijnenborg, MD, PhD
CONTACT
Ruben C.G. Koek, MD / Drs
CONTACT
Radboud University Medical Center
Other
ENDORISK Clinical Implementation Study
Acronym: ENDORISK-I
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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