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临床试验/NCT00575510
NCT00575510已完成不适用

Intervention to Improve Follow-up of Abnormal Pap Test

The University of Texas Medical Branch, Galveston2 个研究点 分布在 1 个国家目标入组 341 人开始时间: 2005年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
341
试验地点
2
主要终点
Adherence to Initial Follow-up (Yes/no)

研究概览

简要总结

This project will examine whether a theory-based telephone intervention delivered by a nurse at the time women are informed of an abnormal Pap test result will increase adherence to follow-up recommendations.

详细描述

Over 90% of deaths due to cervical cancer could be prevented with appropriate screening and treatment of precursor lesions. However, 20% to 70% of women in the United States who are told that their Papanicolaou (Pap) test was abnormal do not adhere to recommendations for follow-up care. This is a problem especially among minorities and women of lower socioeconomic status. The purpose of this part of the protocol is to test a theory-based intervention designed to improve adherence to follow-up among women who experience an abnormal Pap test. The intervention is a message, delivered over the telephone by a nurse, at the time Pap test results are given to patients. The investigators propose to randomize women who experience an abnormal Pap test to one of three groups: (1) targeted cultural belief + knowledge + importance message (intervention), (2) nontargeted belief + knowledge + importance (active control), or (3) standard care only (passive control). All three groups will receive standard care, which is to notify women by telephone of their abnormal results and provide instructions for follow-up. Women assigned to the intervention group also will receive a cultural belief component consistent with their racial/ethnic group, detailed information about follow-up procedures and the consequences of not returning for follow-up, and information regarding the importance of adhering to recommendations, particularly for "low grade" abnormalities. Women assigned to the active control group will receive a nontargeted belief component, plus procedural knowledge and a message on the importance of follow-up. Adherence to initial follow-up will be the primary outcome. Other behavioral outcomes, such as delayed care and completeness of care, also will be assessed over an 18-month interval by chart review. Additionally, the investigators will evaluate psychological outcomes including anxiety and distress. Finally, the investigators will examine the grade of abnormality (low versus high) as an effect modifier. The investigators anticipate that this research will result in an intervention that will improve several important behavioral and psychological outcomes related to abnormal Pap test results. The intervention is guided by a general integrative theoretical framework; therefore, this research will evaluate an intervention strategy that recognizes the importance of targeting culturally relevant beliefs about follow-up and key determinants of behavior (knowledge/skills, salience, environmental constraints) surrounding abnormal Pap test results. Ultimately, the objective of this research is to improve adherence to follow-up among low-income, minority women who are at particular risk of developing cervical cancer.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18 to 55 years who present to the University of Texas Medical Branch (UTMB) clinics for Pap testing.

排除标准

  • Women who are currently pregnant
  • Have a current diagnosis of cervical cancer; or
  • Who are unable to understand English or Spanish.

结局指标

主要结局

Adherence to Initial Follow-up (Yes/no)

时间窗: adherence rates at initial follow-up appointment, 2 weeks to 3 months

Attendance at initial appointment to follow-up abnormal Pap test result

次要结局

  • State Trait Anxiety Inventory (STAI)-State Scale(+ 7-30 days post-intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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