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
Presenter Florian Strasser
Authors F. Strasser1, D. Blum2, D. Koeberle3, R. von Moos4, K. Ribi5, D.C. Betticher6, S. Aebi7, S. Hayoz8, J. Nadig9, S. Mauri10
  • 1Oncology And Palliative Medecine, Kantonsspital St. Gallen, CH-9007 - St. Gallen/CH
  • 2Department Of Cancer Research And Molecular Medicine, European Palliative Care Research Center Clinical, 7491 - Trondheim/NO
  • 3Dept. Oncology/hematology, Kantonsspital St. Gallen, CH-9007 - St. Gallen/CH
  • 4Medizinische Onkologie Und Hämatologie, Cantonal Hospital Graub, CH-7000 - Chur/CH
  • 5Ibcsg, IBCSG, Berne/CH
  • 6Oncology, Hospital Fribourg, Fribourg/CH
  • 7Medizinische Onkologie, Luzerner Kantonsspital, CH-6004 - Luzern/CH
  • 8Sakk, SAKK, Berne/CH
  • 9Intern Medicine, Oncology Buelach, Buelach/CH
  • 10Oncologia, IOSI Oncology Institute of Southern SwitzerlandOspedale Regionale di Lugano, sede Italiano, CH-6962 - Viganello/CH

Abstract

Background

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.