Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT06867705
Status:
RECRUITING
Last Update Posted:
2025-08-01
First Post:
2025-02-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Randomized Controlled Trial of Remote Symptoms Monitoring With Resilience PRO Compared to Care As Usual Only
Sponsor:
Resilience
Organization:
Study Overview
Official Title:
Digital Monitoring With Patient-Reported Outcomes in Cancer Care: A Randomized Controlled Trial RC - 102 (Resilience Care - 102)
Status:
RECRUITING
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RC-102
Brief Summary:
The goal of this clinical trial is to learn if Resilience PRO, a digital solution performing remote symptoms monitoring, can improve the quality of life of patients with a diagnosis of cancer receiving systemic anticancer treatment.
The main question it aims to answer is:
\- Do patients with a diagnosis of cancer receiving systemic anticancer therapy and using Resilience PRO have an improved quality of life? Researchers will compare patients using Resilience PRO plus care as usual to patients receiving care as usual only.
Participants in the intervention arm will use Resilience PRO, a mobile phone application regularly asking participants about their symptoms. For clinically important symptoms, an alert is sent to the care team that can incorporate that information to timely adjust the care of the participants. Participants both in the control arm and in the intervention arm will further receive care as usual.
The main question it aims to answer is:
\- Do patients with a diagnosis of cancer receiving systemic anticancer therapy and using Resilience PRO have an improved quality of life? Researchers will compare patients using Resilience PRO plus care as usual to patients receiving care as usual only.
Participants in the intervention arm will use Resilience PRO, a mobile phone application regularly asking participants about their symptoms. For clinically important symptoms, an alert is sent to the care team that can incorporate that information to timely adjust the care of the participants. Participants both in the control arm and in the intervention arm will further receive care as usual.
Detailed Description:
Resilience PRO is a digital medical device (dMD CE marked, class IIa) that enables the remote monitoring of patients diagnosed with cancer receiving anticancer systemic therapy. Resilience PRO has been positively evaluated by the French health authorities (HAS, Haute Autorité de Santé) and is registered on the French LATM list (Liste des Activités de Télésurveillance Médicale).
Resilience PRO is a software medical device prescribed by cancer treating physicians to collect electronic patient-reported outcomes (ePRO). The Resilience PRO workflow comprises the following steps:
* Step 1. Collection of ePRO
* Step 2. Intelligent analysis and alerts
* Step 3. Adapted care
Resilience PRO is a software medical device prescribed by cancer treating physicians to collect electronic patient-reported outcomes (ePRO). The Resilience PRO workflow comprises the following steps:
* Step 1. Collection of ePRO
* Step 2. Intelligent analysis and alerts
* Step 3. Adapted care
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: