SARC-Digital: interim analysis of the effectiveness of digital health interventions on the quality of life of metastatic sarcoma patients.

Abstract

e23018 Background: Patients with advanced or metastatic sarcoma face several challenges regarding their quality of life.SARC-Digital prospective randomized study aims to evaluate the effectiveness of digital health interventions on the quality of life of patients with advanced/metastatic sarcoma receiving any treatment. The statistical design requires 108 patients. This is an interim analysis. Methods: Patients use an online platform to self-report their quality of life through a questionnaire of 10 preselected side effects (SEs). In a 1:1 randomization, those on the control arm are reminded to inform their medical team of their SEs; those on the intervention arm receive personalized self-care material in addition to these reminders.The SEs in scope are related to daily and not urgent experiences. The material is based on evidence and best practices and does not constitute nor replace medical advice.For patients with 2 or more questionnaire submissions, the evaluation of each SE improvement is based on the most recent submission compared to all previous ones. Results: The study sites’geographic allocation and diversity (public, university and private hospitals) ensure representative population regarding patients’ socioeconomic status and digital skills. As of January 2025, 63 patients have enrolled in the study across 9 sites; 50 have submitted SE questionnaires at least once. Currently, 30% report no SE among the possible options; 26% report 1; 40% report 2-4. The most frequent SEs are fatigue, constipation, nausea (reported by 78%, 52% &50% of patients, respectively); the least frequent is lymphedema (10%). Fatigue has been the most frequent on a site level too (reported by 33%-100% of site-specific patients). 48 patients have submitted questionnaires at least twice, enabling improvement evaluation: Patients in the intervention arm experience higher rates of improvement of their SEs vs the control arm (71.52% vs 59.82%). Among the 10 SEs, patients in the intervention arm exhibit higher improvement in 8, equal in 1, and lower in 1 SE. Conclusions: Real-world data collected in this study showcase the substantial value of patient reported outcomes that capture the experience of metastatic sarcoma patients.Digital health interventions appear to have positive results for most of the side effects. The table illustrates SE frequency, and comparative improvement between the two arms. Side Effect Frequency (reported at least once) Improvement (Intervention Arm) Improvement (Control Arm) Percentage point difference: Intervention vs Control Fatigue 78% 47% 37% +10% Constipation 52% 77% 75% +2% Nausea 50% 92% 86% +6% Dry skin 48% 58% 75% -17% Mucositis 38% 64% 50% +14% Rash 30% 57% 57% +0% Vomiting 26% 90% 50% +40% Sexual dysfunction 18% 75% 60% +15% Neuropathy 16% 75% 50% +25% Lymphedema 10% 50% 33% +17%