Abstract 142TiP
Background
Quality of life (QoL) has emerged as an important endpoint in clinical trials of cancer therapies. Patient-reported outcomes (PRO) are used to monitor symptoms and health-related QoL. PROs have generated population-based data to the advantage of future patients. Recently, electronic systems have enabled real-time PRO collection, feedback to patients and self-management. CareAcross is a digital platform dedicated to support cancer patients. It has captured the most common symptoms and treatment-related toxicities (TRT) in patients treated for breast, lung, colorectal and prostate cancer in several European countries. Digital interventions through this platform for the different symptoms were found to be beneficial. Sarcoma patients experience more functional impairment, disability and psychosocial distress due to the complexity of treatment and the location of their tumors. Remote monitoring and digital interventions to address the different symptoms of these patients could be beneficial.
Trial Design
This prospective randomized study aims to assess the impact of digital health interventions on improvement of TRT and sarcoma-related symptoms (SRS) in Greece. Secondary endpoints comprise: the impact of improvement of TRT on overall survival, the difference between improvement of TRT and SRS, and patient satisfaction with the digital platform. Recruitment started in September 2023; we plan to enrol 108 patients. Patients regularly report their side-effects, and are randomized into 2 arms. Patients in arm A receive generic information, and recommendation to stay in touch with their clinicians. Patients in arm B receive personalized support based on their treatment and symptoms, consisting of simple, patient-friendly textual material. Patients will be followed up for at least 4 months after inclusion, and up to 6 months. Primary endpoint will be analyzed 6 months after the last patient inclusion. Inclusion criteria are: age of ≥ 18 years, advanced sarcoma, ability to operate in a digital environment, under standard of care treatment (systemic or local) of any line or planned within the next month.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Hellenic Group of Sarcoma and Rare Cancers.
Funding
Has not received any funding.
Disclosure
All authors have declared no conflicts of interest.