Superiority Trial Evaluating Digitalized Information Media for Patients With Advanced Sarcomas Receiving Systemic Treatment.
Phase 3 Superiority Trial Evaluating the Benefit of Dematerialized Information Media for Patients With Advanced Sarcomas Receiving Systemic Treatment for Metastatic or Locally Advanced Disease.
Centre Oscar Lambret
377 participants
May 29, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- Sarcomas of soft tissues or viscera ;
- Inoperable metastatic or locally advanced disease ;
- Indication for systemic treatment with pazopanib, trabectedine, eribulin, ifosfamide or dacarbazine monotherapy ;
- Patient covered by French social security ;
- Written, signed, informed consent ;
Exclusion Criteria6
- Prior inclusion in ePPS trial for a prior systemic treatment ;
- Poor understanding of French ;
- Difficulty accessing a computer ;
- Pregnant or nursing woman ;
- Person deprived of liberty or under guardianship ;
- Impossibility of undergoing medical follow-up for geographical, social or psychological reasons.
Interventions
Post-treatment support with standard support combined with dematerialized support
Locations(11)
View Full Details on ClinicalTrials.gov
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NCT06211257