支持多发性骨髓瘤或慢性淋巴细胞白血病患者自我管理的移动应用程序:试点随机对照试验

IF 3.3 Q2 ONCOLOGY
JMIR Cancer Pub Date : 2023-07-06 DOI:10.2196/44533
Matthew R LeBlanc, Thomas W LeBlanc, Qing Yang, Jennifer McLaughlin, Kerry Irish, Sophia K Smith
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引用次数: 29

摘要

背景:血癌患者在整个癌症过程中都会经历严重的身体和情绪症状。目的:在前期工作的基础上,我们旨在开发一款应用程序,旨在帮助多发性骨髓瘤和慢性淋巴细胞白血病患者自我管理症状,并测试其可接受性和初步疗效。方法:我们根据临床医生和患者的意见开发了血癌教练应用程序。我们的双臂随机对照试验从杜克健康中心招募了参与者,并与肿瘤社会工作协会、白血病和淋巴瘤协会以及其他患者团体合作。参与者被随机分配到注意力控制组(Springboard Beyond Cancer网站)或血癌教练应用程序干预组。全自动血癌教练应用程序包括症状和痛苦跟踪,量身定制的反馈,药物提醒和依从性跟踪,多发性骨髓瘤和慢性淋巴细胞白血病教育资源,以及正念活动。通过血癌教练应用程序在基线、4周和8周收集两组患者报告的数据。感兴趣的结果是整体健康(患者报告的结果测量信息系统全球健康)、创伤后应激(DSM-5创伤后应激障碍清单)和癌症症状(埃德蒙顿症状评估系统修订版)。在干预组的参与者中,满意度调查和使用数据被用来评估可接受性。结果:在下载应用程序的180例患者中,49%(89例)的患者同意参与,40%(72例)的患者完成基线调查。在完成基线调查的患者中,53%(38人)完成了第4周的调查(干预16人,对照组22人),39%(28人)完成了第8周的调查(干预13人,对照组15人)。大多数参与者发现该应用程序至少在帮助控制症状(87%)、寻求帮助(87%)、提高资源意识(73%)方面中等有效,并报告对该应用程序总体满意(73%)。在为期8周的研究期间,参与者平均完成了248.5个应用程序任务。应用程序中最常用的功能是用药记录、痛苦追踪、指导冥想和症状追踪。在第4周或第8周,对照组和干预组在任何结果上没有显著差异。随着时间的推移,我们也没有看到干预组的显著改善。结论:我们的可行性试验结果很有希望,大多数参与者发现该应用程序有助于控制他们的症状,报告了对该应用程序的满意度,并且在几个重要领域有所帮助。然而,我们没有发现在2个月内症状明显减轻或整体身心健康得到改善。对于这项基于应用程序的研究来说,招聘和留住员工是一项挑战,其他人也有同样的经历。限制包括主要是白人和受过大学教育的样本。未来的研究将很好地包括自我效能的结果,针对那些有更多症状的人,并强调招聘和保留的多样性。试验注册:ClinicalTrials.gov NCT05928156;https://clinicaltrials.gov/study/NCT05928156。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

A Mobile App to Support Self-Management in Patients with Multiple Myeloma or Chronic Lymphocytic Leukemia: Pilot Randomized Controlled Trial.

A Mobile App to Support Self-Management in Patients with Multiple Myeloma or Chronic Lymphocytic Leukemia: Pilot Randomized Controlled Trial.

Background: Patients with blood cancer experience serious physical and emotional symptoms throughout their cancer journey.

Objective: Building on previous work, we aimed to develop an app designed to help patients with multiple myeloma and chronic lymphocytic leukemia self-manage symptoms and test it for acceptability and preliminary efficacy.

Methods: We developed our Blood Cancer Coach app with input from clinicians and patients. Our 2-armed randomized controlled pilot trial recruited participants from Duke Health and nationally in partnerships with the Association of Oncology Social Work, Leukemia and Lymphoma Society, and other patient groups. Participants were randomized to the attention control (Springboard Beyond Cancer website) arm or the Blood Cancer Coach app intervention arm. The fully automated Blood Cancer Coach app included symptom and distress tracking with tailored feedback, medication reminders and adherence tracking, multiple myeloma and chronic lymphocytic leukemia education resources, and mindfulness activities. Patient-reported data were collected at baseline, 4 weeks, and 8 weeks for both arms through the Blood Cancer Coach app. Outcomes of interest were global health (Patient Reported Outcomes Measurement Information System Global Health), posttraumatic stress (Posttraumatic Stress Disorder Checklist for DSM-5), and cancer symptoms (Edmonton Symptom Assessment System Revised). Among participants in the intervention arm, satisfaction surveys and usage data were used to evaluate acceptability.

Results: Among 180 patients who downloaded the app, 49% (89) of them consented to participate and 40% (72) of them completed baseline surveys. Of those who completed baseline surveys, 53% (38) of them completed week 4 surveys (16 intervention and 22 control) and 39% (28) of them completed week 8 surveys (13 intervention and 15 control). Most participants found the app at least moderately effective at helping manage symptoms (87%), feeling more comfortable seeking help (87%), increasing awareness of resources (73%), and reported being satisfied with the app overall (73%). Participants completed an average of 248.5 app tasks over the 8-week study period. The most used functions within the app were medication log, distress tracking, guided meditations, and symptom tracking. There were no significant differences between the control and intervention arms at week 4 or 8 on any outcomes. We also saw no significant improvement over time within the intervention arm.

Conclusions: The results of our feasibility pilot were promising in which most participants found the app to be helpful in managing their symptoms, reported satisfaction with the app, and that it was helpful in several important areas. We did not, however, find significantly reduced symptoms or improved global mental and physical health over 2 months. Recruitment and retention were challenging for this app-based study, an experience echoed by others. Limitations included a predominantly White and college educated sample. Future studies would do well to include self-efficacy outcomes, target those with more symptoms, and emphasize diversity in recruitment and retention.

Trial registration: ClinicalTrials.gov NCT05928156; https://clinicaltrials.gov/study/NCT05928156.

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来源期刊
JMIR Cancer
JMIR Cancer ONCOLOGY-
CiteScore
4.10
自引率
0.00%
发文量
64
审稿时长
12 weeks
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