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通过癌症幸存者治疗后健康结局(POSTHOC)移动应用程序实现生存护理计划数字化:一项 II 期随机对照试验方案。

Digitizing Survivorship Care Plans Through the POST-Treatment Health Outcomes of Cancer Survivors (POSTHOC) Mobile App: Protocol for a Phase II Randomized Controlled Trial.

机构信息

Department of Pain and Translational Symptom Science, University of Maryland School of Nursing, Baltimore, MD, United States.

Cornell University, Ithaca, NY, United States.

出版信息

JMIR Res Protoc. 2024 Sep 5;13:e59222. doi: 10.2196/59222.


DOI:10.2196/59222
PMID:39235855
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11413545/
Abstract

BACKGROUND: Survivorship care plans (SCPs) are provided at the completion of cancer treatment to aid in the transition from active treatment to long-term survivorship. They describe the details of a patient's diagnosis and treatment and offer recommendations for follow-up appointments, referrals, and healthy behaviors. The plans are currently paper-based and become outdated as soon as a patient's health status changes. There is a need to digitize these plans to improve their accessibility, modifiability, and longevity. With current technology, SCPs can be linked to mobile devices and activity trackers so that patients can track health behaviors and compare them to their clinical goals, taking charge of their own health. OBJECTIVE: A mobile app, POSTHOC (POST-Treatment Health Outcomes of Cancer Survivors), that digitizes the SCP was developed, with goals of integrating it with wearable technologies and electronic medical records. Herein, we are conducting a randomized controlled trial that evaluates the POSTHOC app versus the traditional SCP on total symptom burden in the early posttreatment period. METHODS: We will recruit 54 patients who have recently completed curative therapy for cancer (any type) in person and remotely. They will be randomized 2:1, POSTHOC:usual care (unblinded). Those randomized to the POSTHOC group will receive their SCP via the app and will choose to focus on nutrition or exercise for the duration of the study based on their individual plan and personal preferences. Those randomized to the control group will get a paper-based plan. At baseline, 6 weeks, and 12 weeks, we will evaluate patient-reported outcomes, including total symptom burden (web-based questionnaire), diet (24-hour Automated Self-Administered [ASA24]), and physical activity (Fitbit Charge 6 [Google LLC]). We will also collect quantitative and qualitative feedback on the usability of the app from those in the POSTHOC arm to improve the app for future implementation studies, with a specific focus on patient-provider communication. For feasibility, we will calculate the percentage of patients who used the POSTHOC app at least 3 times per week. We will use linear mixed models to evaluate the effects of the POSTHOC app versus those of usual care on other outcomes at weeks 6 and 12. RESULTS: This trial is open to accrual in the University of Maryland Medical System as of March 2024, and as of July 3, 2024, a total of 20 participants have consented. CONCLUSIONS: This study is among the first to digitize the SCP in a mobile app and test the effects of a mobile health-delivered behavioral health intervention on symptom burden in cancer survivors. Our results will provide evidence about the effects of health self-management on symptoms. This knowledge will be integral to larger randomized controlled studies, integration with the electronic medical record, and nationwide implementation. TRIAL REGISTRATION: ClinicalTrials.gov NCT05499663; https://clinicaltrials.gov/ct2/show/NCT05499663. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/59222.

摘要

背景:生存护理计划 (SCP) 在癌症治疗完成后提供,以帮助从积极治疗过渡到长期生存。它们描述了患者诊断和治疗的详细信息,并提供了随访预约、转介和健康行为的建议。这些计划目前是基于纸张的,一旦患者的健康状况发生变化,就会过时。需要将这些计划数字化,以提高其可访问性、可修改性和寿命。通过当前技术,SCP 可以与移动设备和活动追踪器链接,以便患者可以跟踪健康行为,并将其与临床目标进行比较,从而掌控自己的健康。 目的:开发了一种名为 POSTHOC(癌症幸存者治疗后健康结果)的移动应用程序,用于数字化 SCP,其目标是将其与可穿戴技术和电子病历集成。在此,我们正在进行一项随机对照试验,评估 POSTHOC 应用程序与传统 SCP 在治疗后早期的总症状负担方面的效果。 方法:我们将亲自和远程招募 54 名最近完成癌症根治性治疗(任何类型)的患者。他们将按照 2:1 的比例随机分为 POSTHOC:常规护理(非盲)。随机分配到 POSTHOC 组的患者将通过应用程序获得他们的 SCP,并将根据他们的个人计划和个人偏好选择专注于营养或运动。随机分配到对照组的患者将获得纸质计划。在基线、6 周和 12 周时,我们将评估患者报告的结果,包括总症状负担(基于网络的问卷)、饮食(24 小时自动自我管理 [ASA24])和身体活动(Fitbit Charge 6 [Google LLC])。我们还将从 POSTHOC 组收集有关应用程序可用性的定量和定性反馈意见,以改进应用程序,为未来的实施研究提供信息,特别关注医患沟通。为了可行性,我们将计算至少每周使用 POSTHOC 应用程序 3 次的患者百分比。我们将使用线性混合模型评估 POSTHOC 应用程序与常规护理在第 6 周和第 12 周的其他结果上的效果。 结果:该试验自 2024 年 3 月起在马里兰大学医学系统开始招募,截至 2024 年 7 月 3 日,共有 20 名患者同意参加。 结论:这项研究是首次将 SCP 数字化到移动应用程序中,并测试移动健康提供的行为健康干预措施对癌症幸存者症状负担的影响。我们的研究结果将提供关于健康自我管理对症状影响的证据。这些知识对于更大规模的随机对照研究、与电子病历的整合以及全国范围内的实施至关重要。 试验注册:ClinicalTrials.gov NCT05499663; https://clinicaltrials.gov/ct2/show/NCT05499663. 国际注册报告标识符(IRRID):DERR1-10.2196/59222.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5c4c/11413545/81665d79f963/resprot_v13i1e59222_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5c4c/11413545/d1f6b095d82c/resprot_v13i1e59222_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5c4c/11413545/81665d79f963/resprot_v13i1e59222_fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5c4c/11413545/d1f6b095d82c/resprot_v13i1e59222_fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5c4c/11413545/81665d79f963/resprot_v13i1e59222_fig2.jpg

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J Med Internet Res. 2023-7-26

[3]
Framework to leverage physical therapists for the assessment and treatment of chemotherapy-induced peripheral neurotoxicity (CIPN).

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[4]
The Association between Survivorship Care Plans and Patient-Reported Satisfaction and Confidence with Follow-Up Cancer Care Provided by Primary Care Providers.

Curr Oncol. 2022-9-30

[5]
Time-restricted Eating to Address Cancer-related Fatigue among Cancer Survivors: A Single-arm Pilot Study.

J Integr Oncol. 2022

[6]
The Effects of a Mediterranean Diet Intervention on Cancer-Related Fatigue for Patients Undergoing Chemotherapy: A Pilot Randomized Controlled Trial.

Cancers (Basel). 2022-8-30

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JMIR Mhealth Uhealth. 2022-8-18

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