Facilitating Follow-up Adherence for Abnormal Pap Smears

描述（由申请人提供）：尽管宫颈癌总体下降，但与高加索人相比，非洲裔美国人（AA）和拉丁美洲人的疾病相关发病率和死亡率之间存在很大差异。坚持诊断性阴道镜检查和随访方案是至关重要的异常巴氏涂片结果指示致癌HPV（约75%的异常），因为早期检测和医疗管理可以预防浸润性宫颈癌。然而，在低收入少数民族人口中，坚持初步诊断性阴道镜检查和随后的医疗建议的比例仍然很低。因此，有必要制定和评估对文化敏感的、可移植的健康传播协议的效力，以促进长期遵守。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定制的咨询干预方案进行头对头比较，该方案通过电话或邮寄印刷品提供，旨在评估和解决低收入AA和拉丁美洲人在初次诊断性阴道镜检查预约之前的认知-情感障碍。患者（N=730）将接受障碍评估，并随机分配至：1）标准治疗（SC;通知函加电话预约确认）; 2）电话障碍咨询（CAB-T; SC加通过电话提供的定制认知-情感障碍咨询）;或3）印刷障碍咨询（CAB-P; SC加通过邮件提供的定制认知-情感障碍印刷材料）。另外，本研究的目的是探讨认知-情感中介的干预效果和调节作用的注意风格对个人的认知-情感加工档案。结果指标将评估在15个月的宫颈监测周期内对初次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、宿命论、坚持的动机、侵入/回避思维、健康相关计划）和干预成本效益。将在基线（阴道镜检查前2-4周）以及首次阴道镜检查后1周、9个月和15个月通过电话进行心理社会评估。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意见制定传播计划。该研究汇集了两个关键优势，专业知识：1）宫颈癌风险评估; 2）针对服务不足的高危人群设计和分析可移动的定制咨询方案。研究结果不仅与宫颈癌前疾病的管理有关，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常规护理中，以增加对医疗方案的依从性，以期最终减少服务不足人群中疾病率的差异。

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.