{"title":"Advanced Messaging Intervention for Medication Adherence and Clinical Outcomes Among Patients With Cancer: Randomized Controlled Trial.","authors":"Chen-Xu Ni, Wen-Jie Lu, Min Ni, Fang Huang, Dong-Jie Li, Fu-Ming Shen","doi":"10.2196/44612","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Medication adherence is crucial for improving clinical outcomes in the treatment of patients with cancer. The lack of adherence and adverse drug reactions can reduce the effectiveness of cancer therapy including the quality of life. The commonly used intervention methods for medication adherence continue to evolve, and the age of fifth-generation (5G) messaging has arrived.</p><p><strong>Objective: </strong>In this study, we conducted a prospective, pilot randomized controlled trial to evaluate the effect of 5G messaging on medication adherence and clinical outcomes among patients with cancer in China.</p><p><strong>Methods: </strong>The research population was patients with nonsmall cell lung cancer undergoing pemetrexed chemotherapy who require regular folic acid (FA) and vitamin B12 supplements. The intervention and control groups were assigned to 5G messaging and second-generation (2G) messaging, respectively. The patients' medication adherence and quality of life were assessed at baseline and 1-month and 3-month time points. Moreover, the chemotherapy-related hematologic or nonhematologic toxicities, as well as the serum levels of FA and vitamin B12, were measured.</p><p><strong>Results: </strong>Of the 567 patients assessed for eligibility between January and May 2021, a total of 154 (27.2%) patients were included. Overall, 80 were randomized to the control group and 74 to the intervention group. The odds of adherence in the 5G messaging intervention group were significantly higher than the control group at the 1-month (62/69, 90% vs 56/74, 76%; adjusted odds ratio 2.67, 95% CI 1.02-7.71) and 3-month (50/60, 83% vs 48/64, 75%; adjusted odds ratio 2.36, 95% CI 1.00-5.23) time points. Correspondingly, the FA and vitamin B12 serum levels of patients in the 5G messaging group were higher than those of the control group. Regarding hematologic toxicities, only the incidence of leukopenia in the intervention group was lower than that in the control group (25/80, 31% in the control group vs 12/74, 16% in the intervention group; P=.04). There were no differences in nonhematologic toxicities and quality of life between the 2 groups.</p><p><strong>Conclusions: </strong>In summary, we conclude that compared with conventional 2G text-based messaging, a 5G messaging intervention can better improve medication adherence and clinical outcome among patients with cancer.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry ChiCTR2200058188; https://www.chictr.org.cn/showproj.html?proj=164489.</p>","PeriodicalId":45538,"journal":{"name":"JMIR Cancer","volume":null,"pages":null},"PeriodicalIF":3.3000,"publicationDate":"2023-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10502590/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"JMIR Cancer","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.2196/44612","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Medication adherence is crucial for improving clinical outcomes in the treatment of patients with cancer. The lack of adherence and adverse drug reactions can reduce the effectiveness of cancer therapy including the quality of life. The commonly used intervention methods for medication adherence continue to evolve, and the age of fifth-generation (5G) messaging has arrived.
Objective: In this study, we conducted a prospective, pilot randomized controlled trial to evaluate the effect of 5G messaging on medication adherence and clinical outcomes among patients with cancer in China.
Methods: The research population was patients with nonsmall cell lung cancer undergoing pemetrexed chemotherapy who require regular folic acid (FA) and vitamin B12 supplements. The intervention and control groups were assigned to 5G messaging and second-generation (2G) messaging, respectively. The patients' medication adherence and quality of life were assessed at baseline and 1-month and 3-month time points. Moreover, the chemotherapy-related hematologic or nonhematologic toxicities, as well as the serum levels of FA and vitamin B12, were measured.
Results: Of the 567 patients assessed for eligibility between January and May 2021, a total of 154 (27.2%) patients were included. Overall, 80 were randomized to the control group and 74 to the intervention group. The odds of adherence in the 5G messaging intervention group were significantly higher than the control group at the 1-month (62/69, 90% vs 56/74, 76%; adjusted odds ratio 2.67, 95% CI 1.02-7.71) and 3-month (50/60, 83% vs 48/64, 75%; adjusted odds ratio 2.36, 95% CI 1.00-5.23) time points. Correspondingly, the FA and vitamin B12 serum levels of patients in the 5G messaging group were higher than those of the control group. Regarding hematologic toxicities, only the incidence of leukopenia in the intervention group was lower than that in the control group (25/80, 31% in the control group vs 12/74, 16% in the intervention group; P=.04). There were no differences in nonhematologic toxicities and quality of life between the 2 groups.
Conclusions: In summary, we conclude that compared with conventional 2G text-based messaging, a 5G messaging intervention can better improve medication adherence and clinical outcome among patients with cancer.
Trial registration: Chinese Clinical Trial Registry ChiCTR2200058188; https://www.chictr.org.cn/showproj.html?proj=164489.
背景:药物依从性对改善癌症患者治疗的临床结果至关重要。缺乏依从性和药物不良反应会降低癌症治疗的有效性,包括生活质量。常用的药物依从性干预方法不断发展,第五代(5G)消息传递时代已经到来。目的:在本研究中,我们进行了一项前瞻性、先导性随机对照试验,以评估5G信息对中国癌症患者药物依从性和临床结局的影响。方法:研究人群为接受培美曲塞化疗且需要定期补充叶酸(FA)和维生素B12的非小细胞肺癌患者。干预组和对照组分别被分配到5G消息传递和第二代(2G)消息传递。在基线、1个月和3个月时间点评估患者的药物依从性和生活质量。此外,还测量了化疗相关的血液学或非血液学毒性,以及血清FA和维生素B12水平。结果:在2021年1月至5月期间评估的567例患者中,共有154例(27.2%)患者被纳入。总的来说,80人被随机分配到对照组,74人被随机分配到干预组。5G短信干预组患者1个月的依从率显著高于对照组(62/69,90% vs 56/74, 76%;调整优势比2.67,95% CI 1.02-7.71)和3个月(50/60,83% vs 48/64, 75%;校正优势比2.36,95% CI 1.00-5.23)时间点。相应的,5G短信组患者血清FA和维生素B12水平均高于对照组。在血液学毒性方面,只有干预组白细胞减少发生率低于对照组(对照组为25/ 80,31 %,干预组为12/ 74,16 %;P = .04点)。两组患者的非血液学毒性及生活质量均无差异。结论:综上所述,我们得出结论,与传统的2G短信相比,5G短信干预可以更好地改善癌症患者的药物依从性和临床结果。试验注册:中国临床试验注册中心ChiCTR2200058188;https://www.chictr.org.cn/showproj.html?proj=164489。