Digestive Cancers
Conditions
Keywords
digestive cancer, Surgery, post-operative complication, remote monitoring
Brief summary
In France, digestive cancers are responsible for more than 40,000 deaths per year, or approximately 30% of cancer-related deaths. Surgery is central to the patient's journey, particularly their treatment, and postoperative complications, whether cardiovascular, respiratory, infectious, thromboembolic, or related to postoperative pain, remain common and can have a significant impact on patients' quality of life and long-term outcomes. The implementation of continuous monitoring contributes to optimizing the care pathway and is necessary to improve postoperative outcomes. Postoperatively, remote monitoring has proven its effectiveness in significantly reducing postoperative readmission rates, particularly among patients who have undergone colorectal surgery. It allows for rapid intervention in the event of frequent complications, thus preventing unnecessary hospitalizations. To date, no study has evaluated the efficacy and safety of such a remote monitoring tool compared to conventional management on the clinical and organizational consequences postoperatively. Maela® is an app that allows patients to complete a symptom tracking questionnaire using a mobile device for 90 days following surgery. Surgeons can track new alerts via the solution's web interface. The primary objective of the study is to evaluate the clinical efficacy of the Maela® medical remote monitoring device after elective digestive oncology surgery compared to conventional management.
Interventions
DEVICEMAELA
Patients will benefit from the Maela® solution from the surgical scheduling visit until 90 days (+/- 15 days) following surgery. Maela will be use by patient to answer online questionnaire, which will generate alerts based on the responses. If an alert is generated, the surgeon or their nurse may see the patient early and adapt the care. The management will be at the discretion of the healthcare professionals
Sponsors
Assistance Publique - Hôpitaux de Paris
Hôpital Lariboisière Fernand Widal
Hotel Dieu Hospital
MN Santé
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
This is a multicenter, national, prospective, open-label, controlled, and randomized clinical superiority study conducted at the Stepped Wedge Cluster Randomized Trial (SWT): * Control period: conventional care pathway in accordance with each center's usual management. * Intervention period: care pathway managed by the Maela® solution. Patients will benefit from the Maela® solution from the surgical scheduling visit until 90 days (+/- 15 days) following surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient aged 18 years and older 2. Patient scheduled for digestive oncology surgery: 1. Colectomy for cancer 2. Pancreatectomy for cancer 3. Hepatectomy for cancer 4. Proctectomy for cancer 5. Gastrectomy for cancer 6. Esophagectomy for cancer 3. At least 2 weeks between scheduling and surgery 4. Patient with a smartphone (iOS or Android environment), or living with family members/primary caregivers who have a smartphone with access to cellular data/Wi-Fi 5. Subject affiliated with or beneficiary of a health insurance plan 6. Subject who can read and understand French 7. Subject who has signed informed consent
Exclusion criteria
1. Patient already participating in an interventional clinical trial 2. Adult patient subject to a legal protection measure, guardianship, or deprived of liberty by a judicial or administrative decision 3. Patient unable to complete a questionnaire and without a close caregiver to support the use of the solution 4. Patient with a psychiatric disorder that would prevent them from giving informed consent or receiving optimal treatment and follow-up 5. Minor patient 6. Visually impaired patient 7. Patient with significant psychomotor disorders of the upper limbs 8. Patient with memory disorders 9. Patient without a mobile phone number 10. Patient without internet access 11. Pregnant or breastfeeding woman
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the clinical effectiveness of the Maela® medical remote monitoring device after scheduled digestive oncology surgery compared to conventional management | Day 90 post-surgery | Presence/absence at day 90 post-surgery defined as the composite of : * A grade III to IV complication according to the Clavien-Dindo classification AND/OR * A post-operative readmission related to surgery (defined by an unscheduled readmission and/or a visit to the emergency room). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the effectiveness of remote monitoring using the Maela® solution on post-operative consequences in patients following their oncodigestive surgery | Day 30 and day 90 post-surgery | Presence of at least one grade III to IV complication according to the Clavien-Dindo scale at Day 30 and day 90 post-surgery |
| Evaluate the impact of remote monitoring using the Maela® solution on patients' quality of life | D0, Day 30 and day 90 post-surgery | Change in quality-of-life score using the EORTC QLQ C30 questionnaire at inclusion, D30 and D90 |
| Assess the organizational impact linked to the deployment of the Maela® solution according to the HAS mapping | Day 90 post-surgery | Number of days spent outside the hospital (initial hospitalization and re-hospitalization) within 90 days following surgery |
| Evaluate the medical and economic benefit of patient monitoring with the Maela® solution | Day 90 post-surgery | Evaluate the medical and economic benefit of patient monitoring with the Maela® solution |
| Assess the satisfaction and usability of the solution by healthcare professionals during the two study periods and by patients in the experimental group | Day 30 and day 90 post-surgery | Monthly compliance rate for remote monitoring at D30 and D90, defined by the formula: Compliance rate = (Number of completed questionnaires / Total number of questionnaires) x 100 |
Countries
France
Outcome results
None listed