Facilitating Follow-up Adherence for Abnormal Pap Smears

促进异常子宫颈抹片检查的后续依从性

• 批准号: 7121031
• 负责人: Suzanne M Miller
• 金额: $ 48.98万
• 依托单位: FOX CHASE CANCER CENTER
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-09-15 至 2009-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7121031
• 关键词: African American; Hispanic Americans; behavioral /social science research tag; cancer prevention; cancer risk; cervical /vaginal smear; cervix neoplasms; clinical research; cognition; counseling; early diagnosis; education evaluation /planning; endoscopy; female reproductive system disorder diagnosis; health behavior; health disparity; health education; human subject; information dissemination; medical outreach /case finding; medically underserved population; neoplasm /cancer diagnosis; perception; social psychology; telecommunications; women' s health

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.

描述（由申请人提供）：尽管宫颈癌总体下降，但与白种人相比，非裔美国人 (AA) 和拉丁裔的疾病相关发病率和死亡率之间存在很大差异。在巴氏涂片结果异常表明致癌 HPV（约占异常的 75%）后，坚持诊断性阴道镜检查和随访方案至关重要，因为早期检测和医疗管理可以预防浸润性宫颈癌。然而，在低收入少数群体中，对初始诊断性阴道镜检查和随后的医疗建议的遵守率仍然很低。因此，有必要制定和评估文化敏感、可移植的健康沟通协议的有效性，以促进长期遵守。这项随机对照试验以认知社会健康信息处理 (C-SHIP) 模型为指导，旨在对通过电话或邮寄家庭印刷品提供的定制咨询干预方案进行头对头比较，旨在评估并在初次诊断性阴道镜检查预约之前解决低收入 AA 和拉丁裔人群依从性的认知情感障碍。患者 (N=730) 将接受障碍评估，并被随机分配至： 1) 标准护理（SC；通知信加电话预约确认）； 2) 电话障碍咨询（CAB-T；SC 加上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 加上通过邮件递送的定制认知情感障碍印刷材料）。其他目的是探索干预影响的认知情感中介因素以及注意力风格对个人认知情感加工概况的调节作用。结果测量将评估对初始阴道镜检查的依从性以及 15 个月宫颈监测周期内的后续管理建议、认知情感过程（风险相关知识/感知、宿命论、依从动机、侵入性/回避观念、健康相关规划）和干预成本效益。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 个月时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和专业知识：1）宫颈癌风险评估； 2) 针对服务不足的高危群体设计和分析可移植的定制咨询方案。研究结果不仅与癌前宫颈疾病的管理相关，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日常护理中，以提高对医疗方案的依从性，以期最终减少服务不足的人群中疾病发生率的差异人口。