Superiority Trial Evaluating Digitalized Information Media for Patients With Advanced Sarcomas Receiving Systemic Treatment.

Condition(s) studied

Investigational drug(s) / intervention(s)

Dematerialized Personalized Care Plan (ePCP): Post-treatment support with standard support combined with dematerialized support

Study summary

ePPS-2202 is a study designed to evaluate the benefits of a dematerialised personalised care plan (PCP) compared to standard information/PCP for patients with advanced sarcomas receiving systemic treatment.

Participants will be randomised to an experimental group or a control group. Patients in the experimental group will receive the dematerialised PCP in addition to the standard PCP while patients in the control group will receive the standard PCP alone.

All patients will be followed until the end of second-line treatment, the start of a new line of treatment, or until the 24-month follow-up.

Eligibility

Primary outcome measure(s)

• Severe toxicity in the first 3 months of treatment — 3 months
  Severe toxicity will be assessed through the reporting of adverse events (AE). Will be considered as an AE all indesirable medical event regardless of the cause, occurring between randomisation and the end of treatment + 30days or the start of a new systemic anti-cancer treatment or the 24-month follow-up. All AE grade ≥ 3 according to Common Terminology Criteria for Adverse Events v5.0 scale (NCI-CTCAE) will be considered severe.

Trial sites (11)

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