Randomized Trial of In-Home Cervical Cancer Screening in Underscreened Women

对筛查不足的女性进行家庭宫颈癌筛查的随机试验

基本信息

批准号：
8503223
负责人：
RACHEL L. WINER
金额：
$ 65.87万
依托单位：
UNIVERSITY OF WASHINGTON
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-04-24 至 2018-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8503223
关键词：
Adherence Age Age-Years Attitude Behavioral Sciences Cancerous Carcinoma in Situ Cervical Cervical Cancer Screening Chronic Disease Clinic Clinical Clinical Trials Cytology Data Diagnosis Early Diagnosis Early treatment Effectiveness of Interventions Ethnic Origin FDA approved Female Guidelines HPV-High Risk Health High Risk Woman Histologic Home environment Human Papillomavirus Infection Insurance Integrated Delivery of Health Care Intervention Interview Mails Malignant neoplasm of cervix uteri Managed Care Measures Medical center Morbidity - disease rate Neoplasms Obesity Outcome Pap smear Patients Predictive Value Primary Health Care Provider Quality of Care Race Randomized Randomized Controlled Trials Recommendation Research Personnel Research Priority Residencies Rural Sampling Services Socioeconomic Status Surveys System Test Result Testing Texas Time Triage Universities Washington Woman aged arm base cancer prevention cervical cancer prevention compare effectiveness cost effective cost effectiveness design disability evidence base experience follow-up human old age (65+)improved innovation interest mortality novel strategies prevention service primary outcome programs public health relevance randomized trial screening secondary outcome tobacco screening treatment as usual uptake

项目摘要

DESCRIPTION (provided by applicant): Over half of all cervical cancers in the U.S. are diagnosed in unscreened or under screened women. New national guidelines identify increasing screening uptake as the number one priority for reducing cervical cancer-related morbidity and mortality. Innovative screening strategies that eliminate the need for clinic-based screening could be highly effective in improving screening compliance while maintaining high-quality care. There is growing interest in using high-risk (hr) HPV screening followed by cytology-based triage of women with hrHPV as a primary screening strategy, with studies suggesting that such a strategy could be both cost- effective and sensitive for detecting cervical neoplasia. If samples for hrHPV screening could be self-collected at home (with in-clinic follow-up of hrHPV-positive women), the need for in-clinic screening could be eliminated for a majority of women. We propose a large, pragmatic randomized controlled trial within Group Health (a large integrated health care delivery system in Washington State) to compare effectiveness of two programmatic approaches to increasing cervical cancer screening among overdue women aged 30-65 years. The first approach (control arm) is usual care at Group Health, which consists of patient- and provider-level services to promote adherence to Pap screening, and the second approach (intervention arm) includes usual care plus a mailed in-home hrHPV screening kit. Primary outcomes are early detection and treatment of cervical neoplasia and secondary outcomes are cervical cancer screening uptake, predictors of screening, and patient experiences and attitudes towards in-home hrHPV testing and follow-up of hrHPV+ results (measured through surveys and interviews). We will identify all 30 to 65 year old female enrollees who are overdue for routine Pap screening (no Pap test within the last 3.4 years). We will randomize 7,200 to in-home hrHPV screening and the remainder (~10,400) to usual care. Compared to usual care, we hypothesize that in-home hrHPV screening will enhance early detection and treatment of cervical neoplasia and improve compliance with screening. The trial will provide definitive evidence-based data on the impact of an in-home hrHPV screening program in a real-world clinical setting.

描述（由申请人提供）：在美国的所有宫颈癌中，有一半以上是在未经筛查或筛查的妇女中诊断出的。新的国家指南确定筛查吸收的增加是降低与宫颈癌相关的发病率和死亡率的首要任务。消除基于诊所的筛查需求的创新筛查策略在维持高质量护理的同时，可以非常有效地提高筛查合规性。对使用高风险（HR）HPV筛查，然后是基于细胞学的HRHPV妇女作为主要筛查策略的三叶草的兴趣越来越大，研究表明，这种策略既可以具有成本效益，既可以有效又敏感，既可以检测宫颈肿瘤。如果样本对于HRHPV筛查，可以在家中自行收集（对HRHPV阳性妇女进行临时随访），大多数妇女可以消除对临床筛查的需求。我们提出了一项大型的，务实的随机对照试验（华盛顿州的一个大型综合医疗保健提供系统），以比较两种程序化方法，以增加30-65岁过期妇女的宫颈癌筛查的有效性。第一种方法（控制臂）是集团健康的通常护理，该方法由患者和提供者级服务组成，以促进遵守PAP筛查，第二种方法（干预组）包括常规护理以及邮寄的家庭HRHPV筛选套件。主要结果是对宫颈肿瘤的早期检测和治疗，次要结局是宫颈癌筛查的摄取，筛查的预测以及对HRHPV+ HRHPV+结果随访的患者经验和态度（通过调查和访谈测量）。我们将确定所有30至65岁的女性入学者，这些女招待会逾期常规PAP筛查（在过去3.4年内没有PAP测试）。我们将将7,200个随机为家庭HRHPV筛查，其余（〜10,400）到通常的护理。与通常的护理相比，我们假设在家中HRHPV筛查将增强宫颈肿瘤的早期检测和治疗，并提高对筛查的依从性。该试验将提供有关在现实世界中临床环境中内部HRHPV筛查计划的影响的确定基于证据的数据。