Reducing Urban Cervical Cancer Disparities Using a Tailored mHealth Intervention to Enhance Colposcopy Attendance

使用量身定制的移动医疗干预措施来减少城市宫颈癌的差异，以提高阴道镜检查的出勤率

• 批准号: 10659894
• 负责人: SHAWNA V. HUDSON
• 金额: $ 70.91万
• 依托单位: RESEARCH INST OF FOX CHASE CAN CTR
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-15 至 2027-12-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10659894
• 关键词: Address; Adoption; Affect; Appointment; Appointments and Schedules; Attention; Behavior Therapy; Cancer Control; Cellular Phone; Cervical; Clinic; Cognitive; Colposcopy; Communication; Counseling; Databases; Dedications; Diagnosis; Diagnostic tests; Disparity; Dissemination and Implementation; Early Diagnosis; English Language; Ethnic Origin; Evidence based intervention; Exploration, Preparation, Implementation, and Sustainment; Feedback; Grain; Health; Health behavior; Health system; Healthcare; Healthcare Systems; Hybrids; Intervention; Intervention Studies; Interview; Language; Link; Longterm Follow-up; Low income; Malignant Neoplasms; Malignant neoplasm of cervix uteri; Medical Care Team; Methods; Minority Women; Modeling; Monitor; National Cancer Institute; Patient Monitoring; Patient Schedules; Patients; Physicians; Population; Protocols documentation; Race; Randomized; Randomized, Controlled Trials; Regimen; Research; Research Design; Resource-limited setting; Resources; Schedule; Sequential Multiple Assignment Randomized Trial; Site; Structure; Surveys; System; Target Populations; Telephone; Test Result; Testing; Text; Text Messaging; Time; Underserved Population; United States National Institutes of Health; Woman; cancer health disparity; cancer risk; cervical cancer prevention; contextual factors; disorder risk; disparity gap; effectiveness evaluation; effectiveness/implementation study; effectiveness/implementation trial; efficacy evaluation; evidence base; follow-up; health assessment; health literacy; implementation framework; implementation intervention; implementation outcomes; information processing; innovation; intervention effect; low health literacy; mHealth; member; mortality; novel; operation; primary outcome; programs; recruit; screening; secondary outcome; social; standard of care; telephone based; telephone coaching; theories; trial design; underserved minority; uptake

PROJECT SUMMARY/ABSTRACT Cervical cancer is one of the most preventable cancers and when diagnosed early and appropriately treated, the likelihood of survival is close to 100%. However, nonattendance at abnormal follow-up appointments reaches 63% among urban, underserved minority women. Cervical cancer prevention and timely diagnosis requires that patients be monitored over time. Existing intervention protocols to promote attendance have significant limitations given a limited focus on urban, underserved minority women and reduced sustainability in resource- limited settings. To fill this void, we propose a tailored mHealth intervention available in both English and Spanish targeting follow-up attendance for abnormal test feedback at 3 urban clinic sites serving predominately low- income minority women. We propose a hybrid Type 1 effectiveness-implementation trial that is theoretically- guided by the Cognitive-Social Health Information Processing model and the Exploration, Planning, Implementation and Sustainment Implementation Framework to operationalize and assess the efficacy of the Health Enhancement Resource System (HERS) intervention. HERS aims to increase patient follow-up after abnormal test results through text message-based barriers counseling for women and supplemental telephone- based Health Coaching for women who miss their appointment. Using a sequential, multiple assignment, randomized trial (SMART) design and stakeholder-engaged approach our aims are to: (1) conduct a randomized control trial (RCT) using the SMART design to evaluate the efficacy of HERS; (2) qualitatively assess the contextual factors (patient factors, healthcare team resources, and organizational factors) affecting HERS implementation outcomes and potential for scalability and sustainability; and (3) explore patient-level moderators of the relationship between the HERS intervention and attendance at the colposcopy appointment. Women (N=546) scheduled for initial or repeat colposcopy following an abnormal test result will be recruited and randomized to one of 2 conditions (HERS text messages or Standard of Care) and, through the SMART design, will remain in their assigned group or re-randomized to HERS or HERS + Health Coaching, depending on initial appointment attendance. The primary outcome is attendance at the baseline colposcopy and the secondary outcome is long-term follow-up at 12-months. Additional research questions will evaluate the best initial intervention (e.g., Standard of Care or HERS) for increasing attendance at the baseline and 12-month follow-up appointments. In-depth interviews with healthcare stakeholders and exit interviews with patients will assess the impact of team and healthcare system context on the HERS implementation. Finally, exploratory analyses seek to identify moderators of intervention effect (e.g., race/ethnicity, Spanish or English language, health literacy) at baseline and 12-month follow-up appointments to evaluate which patients should receive the HERS intervention as a first-line intervention rather than Standard of Care.

项目摘要/摘要 宫颈癌是最可预防的癌症之一，如果早期诊断并得到适当治疗， 存活率接近100%然而，在非正常的随访预约中， 63%的城市、服务不足的少数民族妇女。宫颈癌的预防和及时诊断需要， 患者需要长期观察。现有的促进出勤率的干预议定书具有重要意义， 由于对城市、服务不足的少数群体妇女的关注有限，资源的可持续性降低， 有限的设置。为了填补这一空白，我们提出了一个量身定制的mHealth干预，有英语和西班牙语两种版本。 针对3个城市诊所的异常检测反馈进行随访， 少数民族妇女。我们提出了一个混合型1有效性实施试验，理论上- 在认知社会健康信息处理模型和探索，规划， 执行和维持执行框架，以实施和评估 健康促进资源系统（HERS）干预。HERS旨在增加患者随访， 通过为妇女提供基于短信的障碍咨询和补充电话， 为错过预约的女性提供健康指导。使用连续的多重分配， 随机试验（SMART）设计和患者参与的方法，我们的目的是：（1）进行随机试验， 使用SMART设计的对照试验（RCT）来评价HERS的疗效;（2）定性评估HERS的 影响HERS的环境因素（患者因素、医疗团队资源和组织因素） 实施结果以及可扩展性和可持续性的潜力;（3）探索患者级别的主持人 HERS干预与阴道镜检查预约的关系。妇女 （N=546）将招募在异常检测结果后计划进行初次或重复阴道镜检查的患者， 随机分配至2种条件之一（HERS短信或标准治疗），通过SMART设计， 将留在其分配的组中或重新随机分配至HERS或HERS +健康指导组，具体取决于初始 预约出席。主要结局是基线阴道镜检查的出席率，次要结局是 结果是12个月的长期随访。额外的研究问题将评估最好的初始 干预（例如，标准治疗或HERS），以增加基线和12个月随访时的就诊率 约会.与医疗保健利益相关者的深入访谈和与患者的离职访谈将评估 团队和医疗保健系统环境对HERS实施的影响。最后，探索性分析寻求 为了识别干预效果的调节器（例如，种族/民族、西班牙语或英语、卫生知识）， 基线和12个月随访，以评估哪些患者应接受HERS干预 作为一线干预措施，而不是标准治疗。