Development and Testing of Pain Guard: A Randomized Trial Among Chinese Cancer Patients (Preprint)
Authors: Yang Jing , Weng Lizhu , Cai Hongfu , Hu Zhijian , Li Na , Lin Bijuan , Zheng Bin , Du Bin , Liu Maobai , Zhuang Qian , Zheng Zhiyuan 
Published: October 2018

BACKGROUND

The incidence and degree of cancer pain often progresses in discharged patients because of discontinued standard treatments and reductions in medication compliance. Motivated by the need for better pain management in discharged patients, our research team developed a mobile phone application (Pain Guard) for providing continuous treatment for discharged patients suffering from pain.

OBJECTIVE

We aimed to design, construct, and test the Pain Guard in patients managing cancer pain, and evaluate the total remission rate of pain and improvement in quality of life (QoL), in order to realize convergence management of patients within and outside the hospital. The system’s usability, feasibility, compliance, and satisfaction were also assessed.

METHODS

This randomized controlled double-arm study involved 58 patients with cancer pain symptoms. Participants were randomly assigned into the group receiving care through the Pain Guard and the control group receiving only traditional pharmaceutical care. In a pretest, participants were rated using a baseline cancer pain assessment and QoL evaluation. During treatment, the consumption levels of analgesic drugs were recorded every week. After a 4-week study period, another round of cancer pain assessment and QoL evaluation was conducted. Our primary outcome was remission rate of pain, and secondary outcomes were compliance with medication, improvements in QoL, frequency of breakthrough cancer pain (BTcP), incidence of adverse reactions, and satisfaction of patients.

RESULTS

All participants (58 patients) successfully completed the study. There were no significant differences in baseline pain score or baseline QoL scores between groups (P>0.1). At the end of the study, the rate of pain remission in the trial group was significantly higher than that in the control group (P<0.01). The frequency of BTcP in the trial group was considerably lower than that in the control group (P<0.01). The rate of medication compliance in the trial group was considerably higher than that in the control group (P<0.01). Improvements in QoL scores in the trial group were also significantly higher than those in the control group (P<0.01). The incidence of adverse reactions in the trial group (7/31) was much lower than that in the control group (12/27). The 31 participants in the trial group completed a satisfaction survey regarding Pain Guard: 23 (74%) indicated that they were satisfied with receiving pharmaceutical care by Pain Guard, 8 (26%) indicated that they were somewhat satisfied, 2 (6%) indicated neutral feelings, 1 (3%) indicated that they were somewhat dissatisfied, and no participants indicated that they were very dissatisfied.

CONCLUSIONS

Pain Guard can effectively resolve the management dislocation of patients with cancer pain at home, control pain steadily, reduce the incidence of adverse reactions, improve patient compliance, and significantly improve patients’ quality of life. Additionally, Pain Guard operability is good and easily accepted by patients.

CLINICALTRIAL

identifier: ChiCTR1800016066