1423O - Real-time electronic monitoring of patient-reported symptoms and syndromes (PRs): e-mosaic, a multicenter phase III study (SAKK 95/06)
|Date||01 October 2012|
|Event||ESMO Congress 2012|
|Session||Supportive and palliative care|
|Topics|| Supportive Care
F. Strasser1, D. Blum2, D. Koeberle3, R. von Moos4, K. Ribi5, D.C. Betticher6, S. Aebi7, S. Hayoz8, J. Nadig9, S. Mauri10
In incurable cancer patients (pts) chemotherapy (CTx) may be used by oncologists (ONC) to alleviate PRSS. We assessed if E-MOSAIC influences global quality of life (G-QOL) and patient care.Methods
In this prospective, cluster (ONC) randomized trial pts with defined PRSS starting a new line of palliative CTx with expected response rate ≤ 20% completed a mobile computer-based (E-MOSAIC) assessment (Edmonton Symptom [SYM] Assessment Scale, ≤3 additional SYM, nutritional intake, body weight, Karnofsky Score, medications for main PRSS) before 6 consecutive weekly visits. Eligible ONC received (Intervention [IA]) or not (control [CA]) the cumulative computer printout of their pts results. Primary endpoint (PE) was the difference (Δ) between baseline (BL) and week 6 in G-QOL (EORTC-QLQ-C30, #29&30). Sample size per arm was 84 pts from 20 ONC for 80% power to detect a 10 point Δ, significance level 5%. A planned interim analysis with 100 pts showed many for the PE non-evaluable pts: sample size was increased to 264 pts. Due to clustering, a mixed effects model adjusting for BL G-QOL and other preselected covariates was used. Secondary EP included SYM Distress (∑ 10 VAS, 0–10), pts-perceived ONC compassion (∑ 5 VAS, 0–100) and communication, coping, treatment burden and SYM management by nurse report.Results
In 8 centers, 84 ONC treated 264 pts (median 66y; overall survival IA 6.3, CA 5.4 mts) with various tumors. 102 pts (IA: 55; CA: 47) had uninterrupted (> 4/6 visits, same ONC) pat-ONC sequences, required for PE. The between-arm Δ of PE was 6.8 (p = 0.11) in favor of the IA. In a sensitivity analysis with ONC treating ≥2 pts (IA: 50; CA 39 pts) it was 9.0 (p = 0.07). BL G-QOL was the most influential factor (p < 0.01). Intention to treat analysis revealed improvement in SYM Distress (Δ BL-last study visit: IA -4.9 vs. CA 2.0, p= 0.003), compassion (Δ BL-week 6: IA: 18.9 vs. CA: 4.3), communication, treatment burden and coping in favor of the IA. More pts with high SYM had ONC management.Conclusion
Our intervention of real-time monitoring of PRSS, delivered to oncologist, clearly improved SYM distress with a trend to better SYM management, communication and Qol.
Further development is warranted.Disclosure
All authors have declared no conflicts of interest.