Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.
Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, Chicago, IL, United States of America.
Contemp Clin Trials. 2023 Apr;127:107121. doi: 10.1016/j.cct.2023.107121. Epub 2023 Feb 17.
Rates of clinically elevated depressive symptoms among ambulatory oncology patients are higher than in the general population and are associated with poorer health-related quality of life. Furthermore, a reduction in depressive symptoms may be associated with improved cancer survival. Several interventions have demonstrated efficacy in reducing oncologic depressive symptoms, including cognitive-behavioral stress management (CBSM). However, more work is needed to understand how to best implement CBSM into practice, such as through stepped-care approaches and digital health interventions linked to electronic health records (EHR). This manuscript presents the protocol of the My Well-Being Guide study, a pragmatic type 1 effectiveness-implementation hybrid study. This trial will test the effectiveness of My Well-Being Guide, a seven-week structured, CBSM-based digital health intervention designed to reduce depressive symptoms. This trial will also evaluate My Well-Being Guide's implementation across two health systems.
The final sample (N = 4561) will be oncology patients at Northwestern Medicine or University of Miami Health System who are ≥18 years of age; have a cancer diagnosis; elevated depressive symptoms on the Patient-Reported Outcomes Measurement Information System Depression; and primary language is English or Spanish. Data collection will occur at baseline, and 2-, 6-, and 12-months post baseline. Outcome domains include depressive symptoms and implementation evaluation.
This study may provide valuable data on the effectiveness of our depressive symptom management digital health intervention linked to the EHR and the scalability of digital health interventions in general.
在门诊肿瘤患者中，临床显著抑郁症状的发生率高于一般人群，且与较差的健康相关生活质量相关。此外，抑郁症状的减轻可能与改善癌症生存相关。一些干预措施已证明可有效减轻肿瘤患者的抑郁症状，包括认知行为应激管理（CBSM）。但是，仍需要更多的工作来了解如何将 CBSM 最好地付诸实践，例如通过阶梯式护理方法和与电子健康记录（EHR）相关的数字健康干预措施。本文介绍了 My Well-Being Guide 研究的方案，这是一项实用型 1 型有效性-实施混合研究。该试验将测试 My Well-Being Guide 的有效性，My Well-Being Guide 是一种基于 CBSM 的为期七周的结构化数字健康干预措施，旨在减轻抑郁症状。该试验还将评估 My Well-Being Guide 在两个医疗系统中的实施情况。
最终样本（N=4561）将是西北医学或迈阿密大学健康系统中≥18 岁的肿瘤科患者；有癌症诊断；患者报告的结果测量信息系统抑郁中有升高的抑郁症状；且主要语言为英语或西班牙语。数据采集将在基线时进行，并在基线后 2、6 和 12 个月进行。结果域包括抑郁症状和实施评估。
这项研究可能为我们与 EHR 相关的抑郁症状管理数字健康干预措施的有效性以及数字健康干预措施的总体可扩展性提供有价值的数据。
