The Psychosocial Effect of Testing Positive for HPV on Hong Kong Chinese Women With Normal Cervical Cytology
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Change from baseline in anxiety to 6 months
研究概览
简要总结
The use of HPV testing in cervical screening has raised concerns about the effect of a positive HPV result on women's psychological well being. This is a nested psychosocial study of the COCY trial (IRB No. UW 09-377; PI: Prof Hextan Ngan), with the aim to evaluate the psychosocial impact of HPV positivity on Hong Kong Chinese women and the modulating effects of educational intervention on such impact. Potential participants are identified among those who have joint the COCY trial. Participants will be randomized into two groups, namely the control group or intervention group. The control group participants will receive their smear results and an HPV leaflet by post. The intervention group will receive the leaflet and a counseling session on HPV. Self-administered questionnaires will be used to assess participants' psychological condition at the receipt of the smear results and at two months afterward. It is hypothesized that the level of emotional distress measured at smear result notification will be greater than that at two months afterward for all participants. Furthermore, participants in the intervention group will have lower psychological distress than those in the control group at two months after the receipt of their smear results.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Ethnic Chinese women who have enrolled in the COCY trial, and whose smear results are normal cytology with HPV positivity
- •Women who are willing to attend colposcopy
- •Literate in the Chinese language
- •Have given a verbal consent to participate in this study
排除标准
- •Women who are unable to provide a consent to participation.
结局指标
主要结局
Change from baseline in anxiety to 6 months
时间窗: Level of anxiety will be measured at the receipt of cervical smear results, and at 2-months and 6-months afterward.
Anxiety meausred by the Hospital Anxiety and Depression Scale
次要结局
- Change from baseline in depression to 6 months(Level of depression will be measured at the receipt of cervical smear results, and at 2-months and 6-months afterward.)