Using the symptom monitor in a randomized controlled trial: the effect on symptom prevalence and severity.

This randomized controlled trial investigated the effect of reporting physical symptoms by using a systematic symptom monitoring instrument, the Symptom Monitor, on symptom prevalence and severity among patients with cancer in the palliative phase. The overall objective was to achieve symptom relief through systematic and regular symptom reporting by patients themselves. One hundred forty-six patients with cancer in the palliative phase were randomized to either the intervention group (n = 69 with Symptom Monitor) or the control group (n = 77 without Symptom Monitor). Ten physical symptoms with regard to prevalence and severity were monitored. After 2 months, the prevalence of symptoms was lower in the intervention group compared to the control group (prevalent differences 2.1-24.3%) for 9 out of 10 symptoms (except coughing). The intervention group scored a statistically significantly lower prevalence in constipation and vomiting (prevalence differences 24.3% and 18.0%, respectively). In four symptoms (fatigue, lack of appetite, shortness of breath, and nausea), the intervention group had a lower, although not statistically significant, severity score (median differences 0.5-1). In four symptoms (pain, coughing, sleeplessness, and diarrhea), the severity score was the same in both groups (medians 2-4). In two symptoms (constipation and vomiting), the severity score was lower in the control group (median differences -1 and -2). A comparison between the study groups on improved, deteriorated, or steady-state cases showed that the severity score had deteriorated less for 8 out of 10 symptoms in a larger proportion of patients in the intervention group. Although statistical significance was not reached, the prevalence as well as severity of symptoms in the palliative phase of cancer can be influenced by using the Symptom Monitor.

RCT Entities:   Population Interventions Outcomes