Development and evaluation of the Cancer Symptom Management System: Symptom Management Improves your LifE (SMILE)-a randomized controlled trial

Purpose To develop a Cancer Symptom Management System: Symptom Management Improves your LifE (SMILE) and evaluate the effect and feasibility of the system in cancer symptom management. Methods The Cancer Symptom Management System: SMILE was developed, and a nonblinded, randomized controlled trial was conducted. Cancer patients starting adjuvant or palliative chemotherapy (CTx) were enrolled and randomized to control (symptom monitoring), experimental 1 (Exp 1; symptom monitoring + report), or experimental 2 (Exp 2; symptom monitoring + report + Oncology Nursing Society putting evidence into practice (ONS PEP)-guided evidence-based symptom management education) groups in a 1:2:2 ratio (N = 249). To evaluate whether symptom management education provided additional benefit to continuous symptom monitoring, the Exp 1 and Exp 2 groups were compared utilizing Mann-Whitney U test and generalized estimating equations (n = 199). Results Symptom severity (symptom total score) at each measurement point was not different among the three groups (p > .05). Fatigue and sleep disturbance changes were different between Exp 1 and Exp 2 among patients receiving adjuvant CTx (p = .042 and p = .008). Fatigue gradually decreased after a peak at the 1st CTx cycle in Exp 2, whereas Exp 1 experienced increasing fatigue until the 3rd CTx cycle. A gradual decrease in sleep disturbance was observed in Exp 2 after the 2nd CTx cycle, whereas Exp 1 experienced a steady increase in the symptom. Participants were willing to participate in symptom monitoring using the cancer symptom management system. Symptom management education was easy to follow and helpful. Conclusion The application of the Cancer Symptom Management System: SMILE incorporating ONS PEP-guided evidence-based symptom management education effectively managed fatigue and sleep disturbance after adjuvant CTx. The feasibility of the system has been demonstrated. Incorporating the system into electronic medical systems and integrating provider input will be necessary.