An eHealth symptom and complication management program for cancer patients with newly created ostomies and their caregivers (Alliance): a pilot feasibility randomized trial.
An eHealth symptom and complication management program for cancer patients with newly created ostomies and their caregivers (Alliance): a pilot feasibility randomized trial.
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DOI：
10.1186/s12885-023-10919-x
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发表时间：
2023-06-10
期刊：
影响因子：
3.8
通讯作者：
Song, Lixin
中科院分区：
文献类型：
--
作者：
Xu, Shenmeng;Tan, Xianming;Ma, Chunxuan;McElyea, Rebecca S. S.;Shieh, Karl;Stover, Angela M. M.;Smith, Angela;Stitzenberg, Karyn;Basch, Ethan;Song, Lixin
新造口的癌症患者面临着降低生活质量（QOL）并增加发病率和死亡率的并发症。这项概念验证研究检查了在造口后护理过渡期间名为“患者报告结局-知情症状管理系统”（PRISMS）的电子健康计划的可行性、可用性、可接受性和初步疗效。我们在23名接受根治性手术治疗的膀胱癌和结直肠癌患者及其护理人员中进行了一项2组试点随机对照试验。在基线评估QOL、一般症状和护理者负担后，参与者被随机分配到PRISMS（n = 16对）或常规护理（UC）（n = 7对）。在60天的干预期后，参与者完成了随访调查和退出后访谈。我们使用描述性统计和t检验来分析数据。我们实现了86.21%的招聘率和73.91%的留存率。在使用系统和生物识别设备的PRISMS参与者中（n = 14，87.50%），46.43%在研究期间使用设备≥ 50天。与会者报告说，PRISMS是有用和可以接受的。与UC患者相比，PRISMS患者的社会幸福感评分随着时间的推移而下降，并且身体和情感幸福感呈上升趋势; PRISMS护理人员的护理负担下降幅度更大。PRISMS的招募和保留率与现有的以家庭为基础的干预研究相当。PRISMS是一种有用且可接受的多层次干预措施，有可能改善需要造口护理的癌症患者及其护理人员在手术后护理过渡期间的健康结果。需要一个足够有力的RCT来测试其效果。ClinicalTrial.gov ID：NCT 04492007。注册日期：30/07/2020。在线版本包含补充材料，可通过10.1186/s12885-023-10919-x获得。
Cancer patients with newly created ostomies face complications that reduce quality of life (QOL) and increase morbidity and mortality. This proof-of-concept study examined the feasibility, usability, acceptability, and initial efficacy of an eHealth program titled the “Patient Reported Outcomes-Informed Symptom Management System” (PRISMS) during post-ostomy creation care transition. We conducted a 2-arm pilot randomized controlled trial among 23 patients who received surgical treatment with curative intent for bladder and colorectal cancer and their caregivers. After assessing QOL, general symptoms, and caregiver burden at baseline, participants were randomly assigned to PRISMS (n = 16 dyads) or usual care (UC) (n = 7 dyads). After a 60-day intervention period, participants completed a follow-up survey and post-exit interview. We used descriptive statistics and t-tests to analyze the data. We achieved an 86.21% recruitment rate and a 73.91% retention rate. Among the PRISMS participants who used the system and biometric devices (n = 14, 87.50%), 46.43% used the devices for ≥ 50 days during the study period. Participants reported PRISMS as useful and acceptable. Compared to their UC counterparts, PRISMS patient social well-being scores decreased over time and had an increased trend of physical and emotional well-being; PRISMS caregivers experienced a greater decrease in caregiver burden. PRISMS recruitment and retention rates were comparable to existing family-based intervention studies. PRISMS is a useful and acceptable multilevel intervention with the potential to improve the health outcomes of cancer patients needing ostomy care and their caregivers during post-surgery care transition. A sufficiently powered RCT is needed to test its effects. ClinicalTrial.gov ID: NCT04492007. Registration date: 30/07/2020. The online version contains supplementary material available at 10.1186/s12885-023-10919-x.
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