Development and evaluation of the Cancer Symptom Management System: Symptom Management Improves your LifE (SMILE)—a randomized controlled trial
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.
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).
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.
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.
KeywordsCancer Chemotherapy Symptom assessment Symptom management system Patient education
The current study was supported by the Basic Science Research Program through the National Research Foundation of Korea, funded by the Ministry of Education, Science, and Technology (2015R1A1A1A05001342) and a Chungnam National University Research Grant (2018-0543-01).
Compliance with ethical standards
The study was approved by the institutional review board of the participating hospital (approval number: 4-2015-0610). The study was conducted in accordance with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards.
Conflict of interest
The authors declare that they have no conflicts of interest.
- 3.Berry DL, Hong F, Halpenny B, Partridge A, Fox E, Fann JR, Wolpin S, Lober WB, Bush N, Parvathaneni U, Amtmann D, Ford R (2014) The electronic self report assessment and intervention for cancer: promoting patient verbal reporting of symptom and quality of life issues in a randomized controlled trial. BMC Cancer 14:513CrossRefGoogle Scholar
- 9.Abernethy AP, Herndon JE 2nd, Wheeler JL, Day JM, Hood L, Patwardhan M, Shaw H, Lyerly HK (2009) Feasibility and acceptability to patients of a longitudinal system for evaluating cancer-related symptoms and quality of life: pilot study of an e/Tablet data-collection system in academic oncology. J Pain Symptom Manag 37:1027–1038CrossRefGoogle Scholar
- 15.Ruland CM, Holte HH, Roislien J, Heaven C, Hamilton GA, Kristiansen J, Sandbaek H, Kvaloy SO, Hasund L, Ellison MC (2010) Effects of a computer-supported interactive tailored patient assessment tool on patient care, symptom distress, and patients’ need for symptom management support: a randomized clinical trial. J Am Med Inform Assoc 17:403–410CrossRefGoogle Scholar
- 19.Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D (2016) Symptom monitoring with patient-reported outcomes during routine cancer treatment: a randomized controlled trial. J Clin Oncol 34:557–565CrossRefGoogle Scholar
- 20.Maguire R, Ream E, Richardson A, Connaghan J, Johnston B, Kotronoulas G, Pedersen V, McPhelim J, Pattison N, Smith A, Webster L, Taylor A, Kearney N (2015) Development of a novel remote patient monitoring system: the advanced symptom management system for radiotherapy to improve the symptom experience of patients with lung cancer receiving radiotherapy. Cancer Nurs 38:E37–E47CrossRefGoogle Scholar
- 22.Oncology Nursing Society (2018) Putting evidence into practice (PEP). Oncology Nursing Society. https://www.ons.org/practice-resources/pep. Assessed 7 Oct 2016
- 23.Reeve BB, Mitchell SA, Dueck AC, Basch E, Cella D, Reilly CM, Minasian LM, Denicoff AM, O’Mara AM, Fisch MJ, Chauhan C, Aaronson NK, Coens C, Bruner DW (2014) Recommended patient-reported core set of symptoms to measure in adult cancer treatment trials. J Natl Cancer Inst 106:dju129CrossRefGoogle Scholar
- 25.Cleeland CS, Mendoza TR, Wang XS, Chou C, Harle MT, Morrissey M, Engstrom MC (2000) Assessing symptom distress in cancer patients: the M.D. Anderson Symptom Inventory Cancer, vol 89, pp 1634–1646Google Scholar
- 27.Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC et al (1993) The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst 85:365–376CrossRefGoogle Scholar
- 30.Yamaguchi T, Morita T, Nitto A, Takahashi N, Miyamoto S, Nishie H, Matsuoka J, Sakurai H, Ishihara T, Tarumi Y, Ogawa A (2016) Establishing cutoff points for defining symptom severity using the Edmonton symptom assessment system-revised Japanese version. J Pain Symptom Manag 51:292–297CrossRefGoogle Scholar