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NCT Number: NCT06867705

Randomized Controlled Trial of Remote Symptoms Monitoring With Resilience PRO Compared to Care As Usual Only

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Centre Hospitalier du Pays d'Aix - Centre Hospitalier Intercommunal Aix-Pertuis, Aix-en-Provence, France

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age: Adults ≥ 18 years.
  • Informed Consent: Patient giving signed informed consent to participate in the RC - 102 clinical study.
  • Diagnosis: Patients with cancer at any stage.
  • Systemic Treatment
  • Remote Monitoring Eligibility: Access to a smartphone
  • Language: Ability to understand and communicate in the language(s) in which the trial is conducted.

Exclusion criteria

  • Age: Patients under 18 years of age.
  • Life Expectancy: Patients with a life expectancy of less than 6 months as estimated by the treating physician.
  • Concurrent remote monitoring
  • HSCT or CAR-T Therapy
  • Cognitive Impairment
  • Pregnancy or breastfeeding
  • Subject under administrative or judicial control

Treatment and study plan

Resilience PRO

Device

The patient will use Resilience PRO remote symptoms monitoring.

Primary outcomes

  1. Health-Related quality of life

    Time frame: 3 months

    EORTC QLQ-C30

Secondary outcomes

  1. Health-economic evaluation

    Time frame: 12 months

    The outcome is measured in QALYs. These are calculated from the EQ-5D-5L questionnaire scores.

  2. Overall survival

    Time frame: 36 months

Other outcomes

  1. Experience from patients

    Time frame: 12 months

    Patient experience and usability of the RPM system survey (Patient-Reported Experience Measures PREMs)

  2. Experience from HCP

    Time frame: 12 months

    Healthcare Professionals Experience survey.

Study contacts

Contact information is provided by the study sponsor or research team.

Resilience

CONTACT

[email protected]

+33 805 69 65 61

Sponsors and collaborators

Lead sponsor

Resilience

Industry

Collaborators

  • Sanoia
  • UNICANCER

Registry information

Official study title

Digital Monitoring With Patient-Reported Outcomes in Cancer Care: A Randomized Controlled Trial RC - 102 (Resilience Care - 102)

Acronym: RC-102

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Mar 10, 2025
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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