Facilitating Follow-up Adherence for Abnormal Pap Smears

描述(由申请人提供)：尽管宫颈癌总体上有所下降，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之间存在很大差距。在巴氏涂片结果异常提示致癌HPV(约75%的异常)后，坚持阴道镜诊断和后续治疗方案至关重要，因为早期发现和医疗处理可以预防浸润性宫颈癌。然而，在低收入少数群体中，坚持接受初始诊断阴道镜检查和随后的医疗建议的比率仍然很低。因此，有必要开发和评估对文化敏感的、可运输的健康传播方案的有效性，以促进随着时间的推移而坚持下去。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通过电话或邮寄打印的方式对定制的咨询干预方案进行面对面的比较，旨在评估和解决低收入AA和拉丁裔患者在最初诊断阴道镜检查预约之前遵守的认知-情感障碍。患者(N=730)将接受障碍评估，并将被随机分配到：1)标准护理(SC；通知信+电话预约确认)；2)电话障碍咨询(CAB-T；SC+通过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+通过邮寄的定制认知-情感障碍印刷材料)。另外的目的是探索干预影响的认知-情感中介，以及注意风格对个体认知-情感加工的调节作用。结果衡量标准将评估在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遵守情况，认知-情感过程(与风险有关的知识/看法、宿命论、坚持的动机、侵入性/回避性思维、与健康有关的规划)和干预成本效益。心理社会评估将在基线(阴道镜检查前2-4周)以及阴道镜检查后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意见制定传播计划。这项研究汇集了两个关键优势，即在以下方面的专业知识：1)宫颈癌风险评估；2)针对未得到充分服务的高危人群的可移植定制咨询方案的设计和分析。研究结果不仅与宫颈癌前期疾病的管理有关，而且还将为咨询方案奠定基础，这些方案可以很容易地传播到常规护理中，以增加对医疗方案的遵守，以期最终减少服务不足人群中的发病率差异。

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.