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，超过一半的宫颈癌是在未经筛查或筛查不足的女性中诊断出来的。新的国家指南将提高筛查率确定为降低宫颈癌相关发病率和死亡率的首要任务。消除临床筛查需求的创新筛查策略可以非常有效地提高筛查依从性，同时保持高质量的护理。人们越来越有兴趣使用高危 (hr) HPV 筛查，然后对患有 hrHPV 的女性进行基于细胞学的分类作为主要筛查策略，研究表明这种策略对于检测宫颈肿瘤来说既经济有效又敏感。如果样品由于 hrHPV 筛查可以在家自行收集（对 hrHPV 阳性女性进行诊所随访），因此大多数女性无需进行诊所筛查。我们建议在 Group Health（华盛顿州的一个大型综合医疗保健服务系统）内进行一项大型、务实的随机对照试验，以比较两种方案方法在增加 30-65 岁逾期妇女宫颈癌筛查方面的有效性。第一种方法（对照组）是 Group Health 的常规护理，包括患者和提供者层面的服务，以促进对巴氏筛查的依从性，第二种方法（干预组）包括常规护理加上邮寄的家庭 hrHPV 筛查成套工具。主要结局是宫颈肿瘤的早期发现和治疗，次要结局是宫颈癌筛查的接受率、筛查的预测因素以及患者对家庭 hrHPV 检测和 hrHPV+ 结果随访的经历和态度（通过调查和访谈衡量）。我们将识别所有逾期进行常规巴氏涂片筛查的 30 至 65 岁女性登记者（过去 3.4 年内未进行巴氏涂片检查）。我们将随机分配 7,200 名患者进行家庭 hrHPV 筛查，其余 (约 10,400 名) 患者接受常规护理。与常规护理相比，我们假设家庭 hrHPV 筛查将增强宫颈肿瘤的早期发现和治疗，并提高筛查的依从性。该试验将为家庭 hrHPV 筛查计划在现实临床环境中的影响提供明确的循证数据。