Communication App to Manage Symptoms and Improve Adjuvant Endocrine Therapy Adherence

用于管理症状和提高辅助内分泌治疗依从性的通信应用程序

基本信息

批准号：
10242709
负责人：
Ilana Graetz
金额：
$ 38.09万
依托单位：
EMORY UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2017
资助国家：
美国
起止时间：
2017-09-15 至 2024-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/10242709
关键词：
Adherence Adverse effects Breast Cancer Patient Cancer Center Caring Cellular Phone Chemotherapy and/or radiation Client satisfaction Clinic Visits Communication Computers Control Groups Data Devices Electronic Health Record Enrollment Feedback Goals Health Health Care Costs Hospitalization Insurance Carriers Intervention Malignant Neoplasms Measures Medical Care Team Monitor Office Visits Oncology Operative Surgical Procedures Outcome Participant Patient Care Patient Care Team Patient Noncompliance Patient-Focused Outcomes Patients Pilot Projects Policy Maker Provider Quality of life Randomized Randomized Controlled Trials Recurrence Reporting Research Resources Risk Sampling Survival Rate Symptoms System Tablets Tennessee Testing Time Time Management Treatment outcome Urban Population Visit Woman adherence rate adjuvant endocrine therapy arm base black women cancer recurrence cancer risk clinical practice cost design experience health care service utilization hormone receptor-positive improved intervention effect malignant breast neoplasm medication compliance mortality mortality disparity patient-clinician communication pilot trial racial disparity real time monitoring side effect success symptom management therapy adherence three-arm study treatment as usual trend web-enabled

项目摘要

For women with hormone receptor-positive breast cancer, long-term use of adjuvant endocrine therapy (AET) significantly reduces the risk of hospitalizations, cancer recurrence and mortality, and increases quality of life. Despite the known benefits of AETs, many patients are nonadherent due to adverse side effects. Furthermore, lower adherence among black women may be contributing to the large and growing disparities in mortality outcomes. Real-time monitoring of treatment-related adverse symptoms and adherence could result in more effective management of symptoms, higher medication adherence, and ultimately lower recurrence and mortality. To date, however, only a few interventions have aimed to improve AET adherence, few have targeted symptom management as a means to improve adherence, and of these, none have found a statistically significant impact on adherence. Our proposed study will fill this research gap by testing a web- enabled app designed with the explicit goal of improving long-term AET adherence. Patient-reported symptoms will be integrated directly with the patient's electronic health record in order to improve patient-provider communication about AET adherence and related adverse symptoms outside of clinic visits. In a small pilot trial of the study app, we found that participants who had recently initiated a new AET and received weekly reminders to use the app reported significantly higher adherence to AETs at 8 weeks compared with a control group (91% vs. 68%, p=0.02). The proposed study builds on the success of our pilot study by: 1) expanding the intervention period to six months in order to capture later-onset adverse symptoms that are slower to develop; 2) following participants for one to three years, depending on enrollment year, to test longer-term effects of the intervention on medication adherence and other outcomes; and 3) including a larger sample powered to test multiple levels of the intervention. We will randomize 300 participants to one of three arms: 1) an “App” group (n=100) that will receive weekly reminders to use the PCM app; 2) an “App+Feedback” group (n=100) that will receive weekly reminders and personalized feedback based on their use of the app; or 3) a “Usual Care” group (n=100) that will receive usual care only. The app will include questions about AET adherence and adverse symptoms with built-in alerts sent to the patient's care team if any concerning symptoms or trends are reported. We hypothesize that monitoring symptoms and adherence with actionable alerts and tailored feedback reports to patients will result in timelier symptom management and higher long- term adherence to AET. By evaluating the impact of the intervention on a comprehensive set of measures, including AET adherence, patient outcomes, racial disparities and resource use-related costs, our study will provide valuable and actionable results for providers, policy makers, and insurers who strive to achieve the “Triple Aim” – reduce costs while improving health outcomes and the patient experience.

对于患有激素受体阳性乳腺癌的女性，长期使用辅助内分泌治疗（AET）显着降低住院、癌症复发和死亡率的风险，并提高生活质量。尽管 AET 具有已知的益处，但许多患者由于不良副作用而不依从。黑人妇女的依从性较低可能导致死亡率差异巨大且不断扩大实时监测与治疗相关的不良症状和依从性可能会带来更多结果。有效管理症状，提高用药依从性，最终降低复发率和然而，迄今为止，只有少数干预措施旨在提高 AET 依从性，很少有干预措施能够做到这一点。有针对性的症状管理作为提高依从性的一种手段，其中，没有人发现我们提出的研究将通过测试网络来填补这一研究空白。启用的应用程序设计的明确目标是改善长期 AET 依从性。将直接与患者的电子健康记录集成，以改善患者提供者在一次小型试点中就 AET 依从性和相关不良症状进行沟通。在研究应用程序的试用中，我们发现最近发起新 AET 并每周接受一次的参与者使用该应用程序的提醒报告显示，与对照组相比，第 8 周时对 AET 的依从性显着提高组（91% vs. 68%，p=0.02）。拟议的研究建立在我们试点研究成功的基础上：1）扩大了范围。干预期为六个月，以便捕捉较晚发生的不良症状 2) 根据入学年份，跟踪参与者一到三年，以进行长期测试干预对药物依从性和其他结果的影响；3) 包括更大的样本我们将随机将 300 名参与者分配到三个组之一：1) “应用程序”组 (n=100) 将每周收到使用 PCM 应用程序的提醒 2) “应用程序 + 反馈”组； (n=100) 将根据应用程序的使用情况收到每周提醒和个性化反馈；或 3) 仅接受常规护理的“常规护理”组 (n=100) 该应用程序将包含有关 AET 的问题。依从性和不良症状，如有任何问题，内置警报会发送给患者的护理团队我们力争通过可操作的方式监测症状和依从性。向患者发出警报和量身定制的反馈报告将导致更及时的症状管理和更高的长期治疗效果长期坚持 AET 通过评估干预措施对一系列综合措施的影响，包括 AET 依从性、患者结果、种族差异和资源使用相关成本，我们的研究将为努力实现以下目标的提供商、政策制定者和保险公司提供有价值且可行的结果 “三重目标”——降低成本，同时改善健康结果和患者体验。

项目成果

期刊论文数量（8）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

An examination of health care utilization during the COVID-19 pandemic among women with early-stage hormone receptor-positive breast cancer.

DOI：
10.1186/s12913-022-08705-9
发表时间：
2022-11-23
期刊：
BMC HEALTH SERVICES RESEARCH
影响因子：
2.8
作者：
Paladino, Andrew J.;Pebley, Kinsey;Kocak, Mehmet;Krukowski, Rebecca A.;Waters, Teresa M.;Vidal, Gregory;Schwartzberg, Lee S.;Curry, Andrea N.;Graetz, Ilana
通讯作者：
Graetz, Ilana

"I don't just say, Hi! I'm gay": Sexual Orientation Disclosures in Oncology Clinic Settings Among Sexual Minority Women Treated for Breast Cancer in the U.S. South.

“我不只是说，嗨！我是同性恋”：美国南部接受乳腺癌治疗的性少数女性肿瘤诊所的性取向披露。

DOI：
10.1016/j.soncn.2023.151452
发表时间：
2023
期刊：
Seminars in oncology nursing
影响因子：
2.2
作者：
Anderson,JaneaneN;Paladino,AndrewJ;Robles,Andrew;Krukowski,RebeccaA;Graetz,Ilana
通讯作者：
Graetz,Ilana

The Importance of Lay Summaries for Improving Science Communication.

DOI：
10.1093/abm/kaad027
发表时间：
2023-06
期刊：
Annals of behavioral medicine : a publication of the Society of Behavioral Medicine
影响因子：
0
作者：
Carly M. Goldstein;R. Krukowski
通讯作者：
Carly M. Goldstein;R. Krukowski

"Nobody Will Tell You. You've Got to Ask!": An Examination of Patient-Provider Communication Needs and Preferences among Black and White Women with Early-Stage Breast Cancer.

DOI：
10.1080/10410236.2020.1751383
发表时间：
2021-10
期刊：
Health communication
影响因子：
3.9
作者：
Anderson JN;Graff JC;Krukowski RA;Schwartzberg L;Vidal GA;Waters TM;Paladino AJ;Jones TN;Blue R;Kocak M;Graetz I
通讯作者：
Graetz I