Evaluating a digital care plan for patients with advanced sarcomas on second-line treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the effectiveness of a dematerialised personalised care plan (PCP) compared to standard care for patients with advanced sarcomas receiving second-line treatment. Participants will be randomly assigned to either an experimental group, which receives the dematerialised PCP alongside standard care, or a control group that receives only the standard PCP. The study will monitor patients until the end of their second-line treatment, the initiation of a new treatment, or a follow-up period of 24 months. The primary outcome will focus on the incidence of severe adverse events during the first three months of treatment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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.

Where it's running

• Centre Léon Bérard
  Lyon, Auvergne-Rhône-Alpes, France Recruiting
• CHU Jean Minjoz
  Besançon, Bourgogne-Franche-Comté, France Recruiting
• Centre Paul Strauss
  Strasbourg, Grand Est, France Recruiting
• Centre Oscar Lambret
  Lille, Hauts-de-France, France Recruiting
• CHU de Poitiers
  Poitiers, New Aquitaine, France Recruiting
• Institut de Cancérologie de l'Ouest
  Saint-Herblain, Pays de la Loire Region, France Recruiting

Study contacts

• Principal investigator: Diane PANNIER, MD — Centre Oscar Lambret
• Study coordinator: PANNIER Diane, DR
• Email: d-pannier@o-lambret.fr
• Phone: 03.20.29.59.59

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.