Randomized Controlled Trial of Remote Symptoms Monitoring With Resilience PRO Compared to Care As Usual Only
ConditionCancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorResilience
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Resilience PRO
DeviceThe patient will use Resilience PRO remote symptoms monitoring.
Treatment groups
1,458 Participants
are divided into 2 treatment groupsGroup A: Remote Symptoms Monitoring with Resilience PROExperimental treatment 1 intervention
Group B: Usual care without Remote Symptoms MonitoringNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Health-Related quality of life
EORTC QLQ-C30
Time frame
3 monthsSecondary outcomes
1
Health-economic evaluation
The outcome is measured in QALYs. These are calculated from the EQ-5D-5L questionnaire scores.
Time frame
12 months2
Overall survival
Time frame
36 monthsOther outcomes
1
Experience from patients
Patient experience and usability of the RPM system survey (Patient-Reported Experience Measures PREMs)
Time frame
12 months2
Experience from HCP
Healthcare Professionals Experience survey.
Time frame
12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov