Effects of Decision Aids on the Participation of South Asian Women in Cervical Cancer Screening: A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 270
- 主要终点
- cervical cancer screening uptake
研究概览
简要总结
Objectives: To examine the effects of linguistically appropriate decision aids on decisional conflicts, risk perception, clarity of values, screening decisions and screening uptake among South Asian women in Hong Kong Design and subjects: A randomised controlled trial. A sample of 270 South Asian women aged 25-64 will be recruited to one of the two intervention groups or control group.
Instruments: A survey will be conducted to collect data on the variables of concern (decisional conflicts, risk perception, clarity of values, screening decision and screening uptake).
Interventions: Ethnically match community health workers (CHWs) will deliver the printed or mobile application decision aids to intervention group participants and briefly explain how to use the decision aid. The participants will choose a time and place of their convenience to read the decision aid. The participants will be contacted by CHWs within 2 weeks and asked if they have experienced any problems. Navigation assistance will be given as requested.
Main outcome measures: Decisional conflicts, risk perception, clarity of values, screening decision and uptake.
Data analysis: The repeated-measure outcomes of risk perception, clarity of values, decisional conflicts and screening decision will be compared between the three groups while adjusting for the stratifying variable (ethnicity) using a generalised estimating equation model, and a multivariable logistic regression with adjustment for ethnicity will be used to compare the screening uptake of the three groups.
Expected results: The decision aid will clarify the participants' values and help them to make screening decisions and increase the uptake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 64 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Indian, Pakistani or Nepalese;
- •aged 25 to 64;
- •no history of cervical cancer or total hysterectomy;
- •have a history of sexual activity;
- •cannot understand Chinese but can read or communicate in English, Hindi, Urdu or Nepali;
- •have not had a Pap/HPV test in the past 3 years;
- •have and are willing to use a smartphone in this intervention.
排除标准
- 未提供
结局指标
主要结局
cervical cancer screening uptake
时间窗: 3 months after intervention
The participants will be asked 'Have you undergone cervical cancer screening in the past 3 months?
decisional conflict
时间窗: baseline and 2 weeks after intervention
16-item Decisional Conflict Scale will be used to measure decisional conflict. The scale consists of five subscales: informed subscale, values clarity subscale, support subscale, uncertainty subscale and effective decision subscale. The scores will be converted to a 0-100 scale, giving a possible range of 0 (no decisional conflict) to 100 (extremely high decisional conflict). A score of 25 or below indicates that a person has low decisional conflict, and a score of 37.5 and above indicates that a person has decisional delay.
次要结局
- screening decision: choice predisposition(baseline and 2 weeks after intervention)
- screening decision: choice question(baseline and 2 weeks after intervention)
- risk perception(baseline and 2 weeks after intervention)
研究者
Dorothy Ngo Sheung Chan
Assistant Professor
Chinese University of Hong Kong