Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

this group will benefit from standard care including: one surgical consultation, one anesthesia consultation, surgery followed by 2-4 days of hospitalization and most of the time 3 post-operative consultations (M1, M6, M12) during the first operative year

Preoperative and postoperative protocols will be applied for optimizing same-day discharge. Gynaecologists, anaesthetists, and nursing staff will work as a team. A specific anesthesia consultation will focus on ambulatory surgery management. A geriatric evaluation will be offered to women over 70 years old with a score ≤14 according to G8 screening tool. A dietetic evaluation will be offered to women with BMI ≥ 35. A nursing consultation will be offered, as patient and their family preparation prior to ambulatory surgery is important.

total hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy

ambulatory surgery

standard surgery

Geoffroy CANLORBE, MD

Lise ROCHAIX, MD PHD

To date, cost-utility, safety, and feasibility of ambulatory surgery versus traditional pathway in the management of endometrial cancer have never been prospectively assessed.

The investigators hypothesize that ambulatory surgery versus standard pathway in the management of endometrial cancer is both safe, feasible and may impact on patient health-related quality of life.

The main objective of the study is to assess the cost-utility of ambulatory surgery versus standard pathway in the management of endometrial cancer.

A total of 252 consecutive, eligible, consenting patients with a low- and intermediate-risk early stage endometrial cancer will be enrolled from various clinical practice sites within France and patient will randomly be assigned to one of the two surgical management pathways: ambulatory pathway versus standard pathway.

In developed countries, endometrial cancer is the fourth most common cancer in women. Women with stage I disease, representing almost 75% of cases, have an overall survival of 95%. According to the European guidelines, the standard surgical approach for stage I endometrial cancer consists of laparoscopic total hysterectomy and bilateral salpingo-oophorectomy with or without lymphadenectomy. For patients undergoing laparoscopic surgery for gynecological malignancies, most studies report average hospital stays of 1 day after surgery. Patients are commonly kept in the hospital following surgery for pain and nausea control, prolonged bladder catheterization, and observation for surgical complications. However, some recent retrospective studies show that same-day discharge for patients undergoing laparoscopic staging for endometrial cancer is feasible and safe, despite associated comorbidities (i.e., obesity, hypertension, diabetes) related to endometrial cancer.

A short hospital stay decreases the risk of exposure to hospital infections, causes less disruption to the patient's personal life, results in potential cost savings for patients and relatives, as well as for hospitals, and there is positive feedback regarding the social environment of patients as they return rapidly to daily activities and work.

To date, safety, feasibility and cost-utility of ambulatory surgery versus traditional pathway in the management of endometrial cancer have never been prospectively assessed.

The investigators hypothesize that ambulatory surgery versus standard pathway in the management of endometrial cancer is both safe, feasible and may impact on patient health-related quality of life.

The main objective of the study is to assess the cost-utility of ambulatory surgery versus standard pathway in the management of endometrial cancer.

A total of 252 consecutive, eligible, consenting patients with a low, intermediate- and high-risk early stage endometrial cancer will be enrolled from various clinical practice sites within France and patient will randomly be assigned to one of the two surgical management pathways: ambulatory pathway versus standard pathway.

Preoperative and postoperative protocols (including geriatric and dietetic evaluation, and anesthesia and nursing consultation) will be applied for optimizing same-day discharge of patients randomly assigned to ambulatory surgery.

Data will be collected in conjunction with usual care visit, 1 month after initial surgery.

The economic evaluation will closely follow the 2011 French National Authority for Health (HAS) economic evaluation guidelines and the evaluation proposal will have three complementary parts with a full cooperation between those involved in the evaluation:

First, the economic evaluation will focus on evaluating the cost-utility profile of ambulatory surgery in endometrial cancer in France. This economic evaluation will include a micro-costing study to estimate by direct observation the cost of resources used during the ambulatory pathway, and the total cost of patients' care in each group. The primary endpoint will be the incremental cost-utility ratio using the 30-day health related quality of life. It will be calculated for both groups using health-related quality of life (HRQoL) scores from the EQ-5D and converted to utility scores using French weights. QALYs will be computed at 30 days (primary analysis) using both mortality and HRQoL scores.

Second, the investigators will perform an analysis of patients' and professionals' preferences about ambulatory care pathways. These preferences will be analyzed in depth, using both surveys and recent tools developed in experimental economics. Health care professionals' views and preferences will be collected, using questionnaires and face-to-face interviews both at the beginning of the study (M0). Patients' preferences will be assessed using a Discrete Choice Experiment (DCE) method, which is increasingly used in health economics.

Third, a thorough analysis of the ethical and inequality aspects tied to the development of ambulatory surgery in endometrial cancer will be developed, following the methodological guidance issued in 2013 by the HAS. Special emphasis will be laid on equity issues in the measurement of patients' benefits, using a capability approach (ICECAP-A questionnaire).

Finally, another secondary objective will be to assess the safety and feasibility of ambulatory surgery versus traditional pathway in the management of endometrial cancer, and to validate biomarkers of high risk of nodal involvement in a translational study (complementary budget will be asked for this part).

a multicentre, prospective and randomised study

Cost-utility of Ambulatory Surgery in the Management of Endometrial Cancer(AMBU-ENDO)

Cost-utility, Safety and Feasibility of Ambulatory Surgery Versus Traditional Pathway in the Management of Endometrial Cancer: a Multicentre, Prospective and Randomised Study

It will be calculated for both groups using health-related quality of life (HRQoL) scores from the EQ-5D and converted to utility scores using French weights

QALYs will be computed using both mortality and HRQoL scores

Rate of women requiring overnight admission

Patients' preferences will be assessed using a Discrete Choice Experiment (DCE) method, which is increasingly used in health economics.

Ecole d'econmie de Paris (PSE)-Hospinnomics

Université Montpellier

Université de Rennes 1 CREM CNRS UMR 6211

Assistance Publique - Hôpitaux de Paris

Skin and Connective Tissue Diseases

Rare Diseases

Melanoma

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Participants diagnosed with stage II and stage III melanoma who have undergone surgery

Bristol-Myers Squibb

The purpose of this study is to understand the trade-offs that participants with surgically treated melanoma would be willing to make among key features and outcomes of adjuvant anti-cancer treatments or no adjuvant treatment / observation.

A Study of Adjuvant Melanoma Stakeholder Treatment Preferences

Adjuvant Melanoma Stakeholder Treatment Preference Study

Behaviors and Mental Disorders

Quality of Life

Ocular Melanoma

Intraocular Melanoma

Uveal melanoma patients treated with Ruthenium-106 plaque brachytherapy

Uveal melanoma patients treated with proton therapy

Uveal melanoma patients treated with enucleation

Collection of patient-reported outcomes concerning general and health-related quality of life and impact of uveal melanoma diagnosis

Quality of life questionnaires

Assessment of patient preferences for outcomes of proton therapy and enucleation

Discrete choice experiment

Assessment of shared decision-making from the perspective of the patient (by questionnaire), physician (by questionnaire) and a neutral observer (by audiotape), combined with patient-reported satisfaction and regret of the treatment decision (by questionnaire)

Shared decision-making analysis

Assessment of the impact of side-effects by questionnaire

Impact of side-effects analysis

Nanda Horeweg, MD PhD

Coen RN Rasch, MD PhD

Gré PM Luyten, MD PhD

Marina Marinkovic, MD

Arwen H Pieterse, PhD

Nanda Horeweg, Md PhD

PROQEM is a prospective cohort study among patients diagnosed with uveal melanoma to assess quality of life before and in the first five years after treatment.

PROQEM is a prospective observational cohort study wherein patients with uveal melanoma are registered at diagnosis and are requested to fill in an array of questionaires before treatment and at 3, 6, 12, 24, 36 and 60 months after treatment. A comprehensive overview of the impact of their disease and treatment on quality of life is obtained by systematic assessment of the psychological impact of the initial diagnosis, eye symptoms, physical, emotional, social and role functioning.

In addition, the PROQEM has a substudy called the PROQEM-pco (Preferences, Choices and Outcomes) for the subgroup of patients who are eligible for both proton therapy and enucleation. They are invited to participate in research on patient preferences and shared decision-making. The consultations wherein the treatment decision is made are audiotaped and data on perceived shared decision-making, preferences, decision satisfaction and -regret are collected by questionaires at baseline and in the first 36 months after treatment.

Prospective Registration Of Patient Data and Quality of Life in Eye Melanoma Patients

The PROQEM study adheres to the FAIR principles of data stewardship. Due to privacy regulations the data of the PROQEM study will not be made publicly accessible, but can be made available upon request.

Audiotape, iSHARE, satisfaction with decision scale, decision regret scale

Questionnaire specifically developed for uveal melanoma

Leiden University Medical Center

Senior researcher, department of radiation oncology

Discrete Choice Experiment (DCE)

To provide timely access to new treatments, some eligible drugs can be approved despite uncertainty surrounding the level of clinical benefit they offer patients.

It is not currently known if (and under which circumstances) the public would prefer to wait to access some new drugs in exchange for greater certainty surrounding their clinical benefit.

This study aims to elicit the preferences of the US public for wait times and clinical uncertainty of new drugs.

To elicit this information, in a survey format, respondents will be presented with a hypothetical scenario and asked to state their preferences for new treatments, each with different attributes.

Wait Time Preferences of the US Public for New Drugs: a Discrete Choice Experiment

Wait Time Preferences of the US Public for New Drugs With Uncertain Treatment Benefits: a Discrete Choice Experiment

Preferences for different treatment attributes (including clinical uncertainty and wait time), and trade-offs between these, using a study-specific Discrete Choice Experiment (DCE) Questionnaire. Preferences are measured on relative utility scale (arbitrary units, no min/max). Utility indicates preference e.g., higher values are more preferred (better).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Cost-utility of Ambulatory Surgery in the Management of Endometrial Cancer(AMBU-ENDO)	NCT03580421	Endometrial Can... Endometrial Can...	ambulatory surg... standard surger...	18 Years -	Assistance Publique - Hôpitaux de Paris
A Study of Adjuvant Melanoma Stakeholder Treatment Preferences	NCT05115006	Melanoma		18 Years -	Bristol-Myers Squibb
Prospective Registration Of Patient Data and Quality of Life in Eye Melanoma Patients	NCT05377957	Uveal Melanoma	Quality of life... Discrete choice... Shared decision... Impact of side-...	18 Years -	Leiden University Medical Center
Wait Time Preferences of the US Public for New Drugs: a Discrete Choice Experiment	NCT05936632	Cancer	Discrete Choice...	18 Years -	London School of Economics and Political Science
A Study of Adjuvant Melanoma Stakeholder Treatment Preferences	NCT05115006	Melanoma		18 Years -	Bristol-Myers Squibb
Prospective Registration Of Patient Data and Quality of Life in Eye Melanoma Patients	NCT05377957	Uveal Melanoma	Quality of life... Discrete choice... Shared decision... Impact of side-...	18 Years -	Leiden University Medical Center

Spots Global Cancer Trial Database for discrete choice experiment