Kapoor Akshat, Nambisan Priya
Consumer Health Informatics Lab, Department of Health Services and Information Management, East Carolina University, Greenville, NC, United States.
Department of Health Informatics and Administration, University of Wisconsin-Milwaukee, Milwaukee, WI, United States.
JMIR Res Protoc. 2020 Dec 4;9(12):e23414. doi: 10.2196/23414.
Breast cancer is the most common form of cancer among American women, accounting for 23% of all cancer survivors nationally. Yet, the availability of adequate resources and tools for supporting breast cancer survivors has not kept up with the rapid advancement in treatment options, resulting in unmet supportive care needs, particularly among low-income and minority populations. This study explores an alternative means of delivering breast cancer survivorship care plans (SCPs), with the aim of improving survivor morbidity, patient knowledge, and self-management of treatment-related symptoms, as well as addressing inconsistencies in follow-up care visits.
The overall goal of this study is to improve the uptake of SCP recommendations via an educational intervention for breast cancer survivors, to improve treatment-related morbidity, patient knowledge, self-management, and adherence to follow-up visits. The specific aims of the study are to (1) evaluate the feasibility of the online SCP, and (2) assess the impact of the online SCP on survivorship outcomes.
We will enroll 50 breast cancer survivors who have completed initial breast cancer treatment into a 2-armed, randomized, waitlist-controlled pilot trial, and collect data at baseline and 6 months. For the first aim, we will use mixed methods, including surveys and personal interviews among the intervention group, to determine the feasibility of providing an online, interactive SCP (called ACESO) based on the survivors' online user experience and their short-term adoption. For the secondary aim, we will compare the 2 groups to assess the primary outcomes of survivor knowledge, self-efficacy for self-management, perceived peer support, and adherence to SCP-recommended posttreatment follow-up visits to oncology and primary care; and the secondary outcomes of treatment-related morbidity (body weight, fatigue, depression, anxiety, sexual function, distress, and sleep quality). We assess these outcomes by using measurements from validated instruments with robust psychometric properties.
We have developed and refined the online breast cancer survivorship plan, ACESO, with consultation from breast cancer oncologists, nurses, and survivors. Approval for the study protocol has been obtained from the Institutional Review Board. An advisory board has also been established to provide oversight and recommendations on the conduct of the study. The study will be completed over a period of 2 years.
The results of this pilot study will inform the feasibility and design of a larger-scale pragmatic trial to evaluate the impact of an online breast cancer SCP on treatment-related morbidity and self-efficacy for self-management.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/23414.
乳腺癌是美国女性中最常见的癌症形式，占全国所有癌症幸存者的23%。然而，用于支持乳腺癌幸存者的充足资源和工具的可用性并未跟上治疗选择的快速发展，导致未满足的支持性护理需求，特别是在低收入和少数族裔人群中。本研究探索了一种提供乳腺癌幸存者护理计划（SCP）的替代方法，旨在改善幸存者的发病率、患者知识以及与治疗相关症状的自我管理，并解决后续护理就诊中的不一致问题。
本研究的总体目标是通过对乳腺癌幸存者的教育干预来提高SCP建议的采纳率，以改善与治疗相关的发病率、患者知识、自我管理以及对后续就诊的依从性。该研究的具体目标是：（1）评估在线SCP的可行性；（2）评估在线SCP对幸存者结局的影响。
我们将招募50名已完成乳腺癌初始治疗的幸存者，纳入一项双臂、随机、等待名单对照的试点试验，并在基线和6个月时收集数据。对于第一个目标，我们将使用混合方法，包括对干预组进行调查和个人访谈，以根据幸存者的在线用户体验及其短期采用情况来确定提供基于网络的交互式SCP（称为ACESO）的可行性。对于第二个目标，我们将比较两组，以评估幸存者知识、自我管理的自我效能感、感知到的同伴支持以及对SCP推荐的肿瘤学和初级保健后续就诊的依从性等主要结局；以及与治疗相关的发病率（体重、疲劳、抑郁、焦虑、性功能、痛苦和睡眠质量）等次要结局。我们通过使用具有强大心理测量特性的经过验证的工具进行测量来评估这些结局。
我们在乳腺癌肿瘤学家、护士和幸存者的咨询下，开发并完善了在线乳腺癌幸存者计划ACESO。研究方案已获得机构审查委员会的批准。还设立了一个咨询委员会，以对研究的开展提供监督和建议。该研究将在2年内完成。
这项试点研究的结果将为评估在线乳腺癌SCP对与治疗相关的发病率和自我管理自我效能感的影响的更大规模实用试验的可行性和设计提供信息。
国际注册报告识别码（IRRID）：PRR1-10.
