Development and Testing of Pain Guard: A Randomized Trial Among Chinese Cancer Patients (Preprint)

2018 ◽  
Author(s):  
Jing Yang ◽  
Lizhu Weng ◽  
Hongfu Cai ◽  
Zhijian Hu ◽  
Na Li ◽  
...  

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

2018 ◽  
Author(s):  
Jing Yang ◽  
Lizhu Weng ◽  
Zhikui Chen ◽  
Hongfu Cai ◽  
Xiaoyan Lin ◽  
...  

BACKGROUND The incidence of cancer pain increases in discharged patients because of discontinued standard treatments and reductions in medication adherence. Motivated by the need for better pain management in discharged patients, we developed a mobile phone app (Pain Guard) to provide continuous treatment information and feedback to discharged cancer patients suffering from pain. OBJECTIVE The aim was to design, construct, and test the Pain Guard app in patients managing cancer pain, evaluate the total remission rate of pain and the improvement in quality of life (QoL) to improve pain management for cancer pain patients, and assess patient acceptance of the app. METHODS This randomized controlled double-arm study involved 58 patients with cancer pain symptoms. Participants were randomly assigned to a group receiving care through the Pain Guard app (n=31) or to a control group (n=27) who received 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. The system’s usability, feasibility, app compliance, and satisfaction were also assessed. Our primary outcome was remission rate of pain, and secondary outcomes were medication adherence, improvements in QoL, frequency of breakthrough cancer pain (BTcP), incidence of adverse reactions, and satisfaction of patients. RESULTS All participants (N=58) successfully completed the study. There were no significant differences in baseline pain scores or baseline QoL scores between groups. 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<.001). The frequency of BTcP in the app group was considerably lower than that in the control group (P<.001). The rate of medication adherence in the trial group was considerably higher than that in the control group (P<.001). Improvements in global QoL scores in the trial group were also significantly higher than those in the control group (P<.001). The incidence of adverse reactions in the trial group (7/31) was lower than that in the control group (12/27), especially constipation, with significant differences (P=.01). 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, 5 (16%) indicated that they were somewhat satisfied, 2 (6%) indicated neutral feelings, and 1 (3%) indicated that they were somewhat dissatisfied; no participants indicated that they were very dissatisfied. CONCLUSIONS Pain Guard was effective for the management of pain in discharged patients with cancer pain, and its operability was effective and easily accepted by patients. CLINICALTRIAL Chinese Clinical Trials Registry ChiCTR1800016066; http://www.chictr.org.cn/showproj.aspx?proj=27153


2020 ◽  
Vol 50 (5) ◽  
pp. 581-585
Author(s):  
Yehuan Liu ◽  
Beibei Lin

Abstract Context Pain is one of the most common and intolerable symptoms in cancer patients. But cancer pain control is still negative in China. Objectives This paper explores the application of quality control circle in the treatment of cancer pain in inpatients to improve the quality of life of patients with cancer pain. Method Established a quality control circle group to analyze the current status of cancer pain control in inpatients with moderate cancer pain, set goals, formulate corresponding countermeasures and implement and review them in stages. The plan-do-check-act method was cyclically applied. The Brief Pain Inventory was used to evaluate the cancer pain status of patients with cancer pain hospitalized before (January to April 2016) and after (September to December 2016) the implementation of quality control circle activities. Results The pain control effect of the observation group was significantly better than that of the control group. The mean (standard deviation) of pain severity and pain interference in the observation group were significantly lower than those in the control group (6.21 [2.86] vs 4.31 [2.25], 10.54 [4.10] vs 7.25 [3.77]). There was significant difference after the implementation of quality control circle (P &lt; 0.01). Conclusion Quality control circle activities are used to manage patients with cancer pain, to improve the situation of pain control and to improve the quality of life of patients. This management tool and method is worthy of clinical promotion and application.


BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e032889
Author(s):  
Solveigh Paola Lingens ◽  
Georgia Schilling ◽  
Julia Harms ◽  
Holger Schulz ◽  
Christiane Bleich

IntroductionIn recent years, medical treatment for cancer has improved, thereby increasing the life expectancy of patients with cancer. Hence, the focus in healthcare shifted towards analysing treatments that offer to decrease distress and improve the quality of life of patients with cancer. The psychological burden of patients with cancer originates from all kinds of psychosocial challenges related to diagnosis and treatment. Cancer counselling centres (CCounCs) try to address these concerns. However, the current literature lacks research on the effectiveness of CCounCs. This study aims to assess the effectiveness of CCounCs with regard to distress and other relevant psychosocial variables (quality of life, anxietyand so on).Methods and analysisThis prospective observational study with a non-randomised control group has three measurement points: before the first counselling session (baseline, t0) and at 2 weeks and 3 months after baseline (t1, t2). Patients and their relatives who seek counselling between December 2018 and November 2020 and have sufficient German language skills will be included. The control group will be recruited at clinics and oncological outpatient centres in Hamburg. Propensity scoring will be applied to adjust for differences between the control and intervention groups at baseline. Sociodemographic data, medical data and counselling concerns are measured at baseline. Distress (distress thermometer), quality of life (Short Form-8 Health Survey, European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire-Core 30), anxiety (Generalized AnxietyDisorder-7), depression (Patient HealthQuestionnaire-9) and further psychosocial variables are assessed at all time points. With a total of 787 participants, differences between the intervention and control groups of a small effect size (f=0.10) can be detected with a power of 80%.Ethics and disseminationThe study was registered prior to data collection with the German Registration of Clinical Trials in September 2018. Ethical approval was received by the local psychological ethical committee of the Center for Psychosocial Medicine at the University Medical Centre Hamburg-Eppendorf in August 2018. The results will be published in peer-reviewed journals.Trial registration numberDRKS00015516; Pre-results.


Neurosurgery ◽  
2017 ◽  
Vol 83 (1) ◽  
pp. 146-153 ◽  
Author(s):  
Pierre-Yves Borius ◽  
Stéphanie Ranque Garnier ◽  
Karine Baumstarck ◽  
Frédéric Castinetti ◽  
Anne Donnet ◽  
...  

Abstract BACKGROUND Hypophysectomy performed by craniotomy or percutaneous techniques leads to complete pain relief in more than 70% to 80% of cases for opioid refractory cancer pain. Radiosurgery could be an interesting alternative approach to reduce complications. OBJECTIVE To assess the analgesic efficacy compared with standard of care is the primary goal. The secondary objectives are to assess ophthalmic and endocrine tolerance, drug consumption, quality of life, and mechanisms of analgesic action. METHODS The trial is multicenter, randomized, prospective, and open-label with 2 parallel groups. This concerns patients in palliative care suffering from nociceptive or mixed cancer pain, refractory to standard opioid therapy. Participants will be randomly assigned to the control group receiving standards of care for pain according to recommendations, or to the experimental group receiving a pituitary GammaKnife (Elekta, Stockholm, Sweden) radiosurgery (160 Gy delivered in pituitary gland) associated with standards of care. Evaluation assessments will be taken at baseline, day0, day4, day7, day14, day28, day45, month3, and month6. EXPECTED OUTCOMES We could expect pain improvement in 70% to 90% of cases at day4. In addition we will assess the safety of pituitary radiosurgery in a vulnerable population. The secondary endpoints could show decay of opioid consumption, good patient satisfaction, and improvement of the quality of life. DISCUSSION The design of this study is potentially the most appropriate to demonstrate the efficacy and safety of radiosurgery for this new indication. New recommendations could be obtained in order to improve pain relief and quality of life.


2019 ◽  
Vol 35 (3) ◽  
Author(s):  
Jing Li ◽  
Jinzhi Ji ◽  
Fuyan Liu ◽  
Lingling Wang

Objective: To investigate the clinical efficacy of insulin glargine combined with acarbose in the treatment of elderly patients with diabetes. Methods: One hundred and forty-four elderly patients with diabetes who received treatment between December 2016 and December 2017 in Binzhou People’s Hospital, China, were selected and divided into a control group and an observation group, 72 each, using random number table. The control group was treated with insulin glargine, while the observation group was treated with insulin glargine combined with acarbose. The therapeutic effect, improvement of quality of life and adverse reactions were compared between the two groups. Results: After treatment, fasting blood glucose (FBG), 2h postprandial blood glucose (PBG) and glycosylated hemoglobin (Hb Alc) of the two groups were lower than those before treatment, and the decrease degree of the observation group was significantly larger than that of the control group (P<0.05). The time needed for blood glucose reaching the standard level and daily insulin dosage of the observation group were significantly lower than that of the control group, and the differences were statistically significant (P<0.05). SF-36 scale score of the observation group was significantly better than the control group, and the difference was statistically significant (P<0.05). There was no significant difference in the incidence of adverse reactions between the two groups (P>0.05). Conclusion: The combination of insulin Glargine and Acarbose can significantly control the blood glucose level of elderly patients with diabetes, improve the biochemical indicators, and enhance the quality of life. It is worth promotion in clinical practice. doi: https://doi.org/10.12669/pjms.35.3.86 How to cite this:Li J, Ji J, Liu F, Wang L. Insulin Glargine and Acarbose in the treatment of elderly patients with diabetes. Pak J Med Sci. 2019;35(3):---------. doi: https://doi.org/10.12669/pjms.35.3.86 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


2020 ◽  
pp. 629-633
Author(s):  
Marie Fallon

Pain occurs in more than 50% of patients with advanced disease, interferes with daily functioning and quality of life, and is very often undertreated. Patients can find it difficult to articulate the character of their pains, but it is important to determine whether it is somatic, neuropathic, or visceral since this has important implications for management. For most patients with cancer pain, a three-step approach combining simple or opioid analgesia (depending on severity) along with an adjuvant analgesic (depending on cause) will result in good pain relief, but the challenge is to achieve good pain relief without unacceptable adverse effects.


2020 ◽  
Vol 38 (15_suppl) ◽  
pp. e24149-e24149
Author(s):  
Yong Liu ◽  
Qing Li ◽  
Yang Yu ◽  
Jie Jun Wang ◽  
Han Ping Shi

e24149 Background: The efficacy and safety of low-dose fentanyl transdermal patch (TDF) in the treatment of opioid-naive patients with moderate-to-severe cancer pain has no tyet been confirmed. There are little international studies, and none in mainland China. The aim of this study was to explore the effect and tolerability of low dose of TDF in opioid-naive patients with Chinese moderate-to-severe cancer pain, and evaluate the influence on quality of life and cognitive function. Methods: A prospective, single-arm, non-randomized, open-label, multicenter trial was conducted with 285 opioid-naivepatients with moderate-to-severe cancer pain in 14 tertiary hospitals in mainland China. The initial analgesic dose of TDF was 12.5 µg/h, pain assessment (pain score, pain relief and pain response rate) was performed every 3 days for a total of 9 cycles.Adverse reactions and events were monitored over 24 days. In the meantime, quality of life and cognitive function of patient were evaluated with EORTC QLQ-C30 and MMSE. Results: 285 patients with 267(92.00%) completed the trial were enrolled. The average age was 60 (range 28-87) and the average effective therapeutic dose was 6.3±6.08mg.The total pain relief rate was 98.12% (mean pain score ±SD, 5.7±0.89 vs 3.9±1.28; P < 0.001). The efficacy of low-dose TDF on pain relief was consistent in groups separated by gender (p < 0.001), age (p < 0.001), types of cancer (p < 0.001), and baseline pain intensity (p < 0.001). There were 79 patients (29.59%) in the low-dose subgroup, and the pain response rate of the low-dose subgroup was better than other dose groups within one week (p = 0.0018).The adverse effects were mild. The most common adverse reactions are constipation 7.87%, followed by nausea 11.24%, vomiting 4.12%, drowsiness 1.87% and urine retention 1.5%.There was no difference in the incidence of adverse reactions between the low-dose subgroup and the other groups (p > 0.05). Meanwhile, TDF improved the quality of life of patients with moderate-to-severe cancer pain (mean± SD: 46.44±16.96 vs. 67.04±18.02;p < 0.05), without impairing cognitive function(mean ±SD, 29.13±1.54 vs. 28.98±1.99; p > 0.05). Conclusions: Low-dose TDF is effective for opioid-naive patients with moderate-to-severe cancer pain. Adverse reactions are mild and the quality of life of patients is improvedwith little losson cognitive function. Further randomized controlled studies are warranted to investigate the value of low-dose TDF in the treatment of opioid intolerant cancer pain. Clinical trial information: ChiCTR-ONC-17014080 .


Sign in / Sign up

Export Citation Format

Share Document