Chow Philip I, Showalter Shayna L, Gerber Matthew S, Kennedy Erin, Brenin David R, Schroen Anneke T, Mohr David C, Lattie Emily G, Cohn Wendy F
Center for Behavioral Health and Technology, Department of Psychiatry and Neurobehavioral Sciences, University of Virginia, Charlottesville, VA, United States.
Department of Surgery, University of Virginia, Charlottesville, VA, United States.
JMIR Res Protoc. 2019 Jan 14;8(1):e11452. doi: 10.2196/11452.
Over one-third of cancer patients experience clinically significant mental distress, and distress in caregivers can exceed that of the cancer patients for whom they care. There is an urgent need to identify scalable and cost-efficient ways of delivering mental health interventions to cancer patients and their loved ones.
The aim of this study is to describe the protocol to pilot a mobile app-based mental health intervention in breast cancer patients and caregivers.
The IntelliCare mental health apps are grounded in evidence-based research in psychology. They have not been examined in cancer populations. This pilot study will adopt a within-subject, pre-post study design to inform a potential phase III randomized controlled trial. A target sample of 50 individuals (with roughly equal numbers of patients and caregivers) at least 18 years of age and fluent in English will be recruited at a US National Cancer Institute designated clinical cancer center. Consent will be obtained in writing and a mobile phone will be provided if needed. Self-report surveys assessing mental health outcomes will be administered at a baseline session and after a 7-week intervention. Before using the apps, participants will receive a 30-min coaching call to explain their purpose and function. A 10-min coaching call 3 weeks later will check on user progress and address questions or barriers to use. Self-report and semistructured interviews with participants at the end of the study period will focus on user experience and suggestions for improving the apps and coaching in future studies.
This study is ongoing, and recruitment will be completed by the end of 2018.
Results from this study will inform how scalable mobile phone-delivered programs can be used to support breast cancer patients and their loved ones.
ClinicalTrials.gov NCT03488745; https://clinicaltrials.gov/ct2/show/NCT03488745.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/11452.
超过三分之一的癌症患者经历临床上显著的精神痛苦，而照顾者的痛苦可能超过他们所照顾的癌症患者。迫切需要确定可扩展且具有成本效益的方式，为癌症患者及其亲人提供心理健康干预。
本研究的目的是描述在乳腺癌患者及其照顾者中试点基于移动应用程序的心理健康干预的方案。
IntelliCare心理健康应用程序基于心理学的循证研究。它们尚未在癌症人群中进行过检验。这项试点研究将采用受试者内前后对照研究设计，为潜在的III期随机对照试验提供信息。将在美国国立癌症研究所指定的临床癌症中心招募50名至少18岁且英语流利的个体（患者和照顾者数量大致相等）作为目标样本。将获得书面同意，如有需要将提供一部手机。在基线期和7周干预后，将进行评估心理健康结果的自我报告调查。在使用应用程序之前，参与者将接受30分钟的指导电话，以解释其目的和功能。3周后进行10分钟的指导电话，检查用户进展情况并解决使用中的问题或障碍。在研究期结束时，对参与者进行自我报告和半结构化访谈，重点关注用户体验以及对未来研究中改进应用程序和指导的建议。
本研究正在进行中，招募工作将于2018年底完成。
本研究结果将为如何利用可扩展的手机应用程序来支持乳腺癌患者及其亲人提供信息。
ClinicalTrials.gov NCT03488745；https://clinicaltrials.gov/ct2/show/NCT03488745。
国际注册报告识别码（IRRID）：DERR1-10.2196/11452。
