Facilitating Follow-up Adherence for Abnormal Pap Smears

描述（由申请人提供）：尽管宫颈癌的总体发病率有所下降，但与高加索人相比，非洲裔美国人（AA）和拉丁裔美国人的疾病相关发病率和死亡率存在很大差异。在宫颈涂片检查结果异常（约占异常的75%）显示为致癌型HPV后，坚持阴道镜诊断和随访方案至关重要，因为早期发现和医疗管理可以预防侵袭性宫颈癌。然而，在低收入少数群体中，坚持进行阴道镜初步诊断和随后的医疗建议的比率仍然很低。因此，有必要开发和评估具有文化敏感性的、可运输的健康通信协议的有效性，以促进长期的依从性。在认知-社会健康信息处理（C-SHIP）模型的指导下，这项随机对照试验旨在对一种量身定制的咨询干预方案进行面对面的比较，该方案通过电话或邮寄上门的印刷品提供，旨在评估和解决低收入AAs和拉丁裔患者在初次诊断性阴道镜检查前的认知情感障碍。患者（N=730）将接受障碍评估，并随机分配到：1)标准治疗（SC；通知信加电话预约确认）；2)电话障碍咨询（CAB-T； SC +电话提供的定制认知情感障碍咨询）；或3)打印障碍咨询（CAB-P； SC加上定制的认知情感障碍打印材料，通过邮件发送）。其他目的是探索干预影响的认知-情感中介和注意风格对个体认知-情感加工特征的调节作用。结果测量将评估在15个月的宫颈监测周期中对初始阴道镜检查和后续管理建议的依从性、认知-情感过程（风险相关知识/感知、宿运论、坚持的动机、侵入性/回避性观念、健康相关计划）和干预的成本效益。心理社会评估将在基线（阴道镜检查前2-4周）、阴道镜检查后1周、9个月和15个月通过电话进行。将根据研究结果数据、成本效益分析、患者干预评估以及社区咨询委员会和现场工作人员的投入，制定一项传播计划。这项研究汇集了两个关键优势，即：1)宫颈癌风险评估；2)设计和分析针对服务不足的高危人群的可移动定制咨询方案。研究结果不仅与宫颈癌前病变的管理有关，而且还将为咨询协议奠定基础，这些协议可以很容易地传播到日常护理中，以增加对医疗方案的遵守，最终减少服务不足人群中发病率的差异。

DESCRIPTION (provided by applicant): Despite the overall decline in cervical cancer, there is a large disparity between disease-related incidence and mortality rates for African Americans (AA) and Latinas compared to Caucasians. Adherence to diagnostic colposcopy and follow-up regimens is crucial after an abnormal Pap smear result indicative of oncogenic HPV (approximately 75 percent of abnormalities), since early detection and medical management can prevent invasive cervical cancer. However, rates of adherence to initial diagnostic colposcopy and subsequent medical recommendations remain low among low-income minority populations. Hence, there is a need to develop and evaluate the efficacy of culturally- sensitive, transportable health communication protocols to facilitate adherence over time. Guided by the Cognitive-Social Health Information Processing (C-SHIP) model, this randomized controlled trial aims to conduct a head-to-head comparison of a tailored counseling intervention protocol, delivered through either telephone or mail-home print, designed to assess and address cognitive- affective barriers to adherence among low-income AAs and Latinas prior to the initial diagnostic colposcopy appointment. Patients (N=730) will receive a barriers assessment and will be randomly assigned to: 1) standard care (SC; notification letter plus telephone appointment confirmation); 2) telephone barriers counseling (CAB-T; SC plus tailored Cognitive-Affective Barriers Counseling delivered by phone); or 3) print barriers counseling (CAB-P; SC plus tailored Cognitive-Affective Barriers Print materials delivered via mail). Additional aims are to explore the cognitive-affective mediators of intervention impact and the moderating role of attentional style on the individual's cognitive-affective processing profile. Outcome measures will assess adherence to initial colposcopy and to follow-up management recommendations over the 15-month cervical surveillance cycle, cognitive-affective processes (risk-related knowledge/perceptions, fatalism, motivation to adhere, intrusive/avoidant ideation, health-related planning) and intervention cost-effectiveness. Psychosocial assessments will be conducted by telephone at baseline (2-4 weeks pre-colposcopy), and at 1-week, 9-months, and 15-months post-index colposcopy. A dissemination plan will be developed from study outcomes data, the cost-effectiveness analysis, patient intervention evaluations, and input from a Community Advisory Committee and on-site staff. The study brings together two key strengths, expertise in: 1) cervical cancer risk assessment; and 2) the design and analysis of transportable tailored counseling protocols targeted to underserved at-risk groups. Findings are relevant not only to the management of precancerous cervical disease, but will also lay the groundwork for counseling protocols that can be readily disseminated into routine care to increase adherence to medical regimens, with a view to ultimately reducing the disparity in disease rates among underserved populations.