NCT06867705 Randomized Controlled Trial of Remote Symptoms Monitoring With Resilience PRO Compared to Care As Usual Only
| NCT ID | NCT06867705 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Resilience |
| Condition | Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,458 participants |
| Start Date | 2025-04-01 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 1,458 participants in total. It began in 2025-04-01 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Florian Scotté, MD, PhD
PRINCIPAL INVESTIGATOR
Gustave Roussy, Cancer Campus, Grand Paris
Frequently Asked Questions
Who can join the NCT06867705 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06867705 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 1,458 participants.
Is NCT06867705 currently recruiting?
Yes, NCT06867705 is actively recruiting participants. Contact the research team at support@resilience.care for enrollment information.
Where is the NCT06867705 trial being conducted?
This trial is being conducted at Aix-en-Provence, France, Aix-en-Provence, France, Aurillac, France, Bayonne, France and 11 additional locations.
Who is sponsoring the NCT06867705 clinical trial?
NCT06867705 is sponsored by Resilience. The principal investigator is Florian Scotté, MD, PhD at Gustave Roussy, Cancer Campus, Grand Paris. The trial plans to enroll 1,458 participants.
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