Uncovering and Overcoming the Barriers of Colorectal Cancer Screening Amongst Spouses of Patients With Colorectal Cancer Through a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The proportion of participants that completed the FIT test within three months post enrollment.
研究概览
简要总结
To determine amongst spouses of colorectal cancer patients:
- Screening rates for Colorectal Cancer (CRC) amongst spouses of patients with CRC
- Barriers to screening based on the Health Belief Model (HBM)
- Mediators to behaviour change using the transtheoretical model of behavioural change
- If tailored interventions addressing education, convenience and cost would improve screening rates amongst the spouses
详细描述
Stage 1: Randomization into Intervention versus Control
The eligible participants will be randomized into either "Intervention" or "Control" after the study team obtains participants' informed consent and before they begin doing the questionnaires. A randomisation list is generated using a computer procedure using block randomization. Based on the randomisation list, the assigned groups for each study participant's ID are written in a sealed opaque envelope. The envelope will be open at the point of randomisation to find out which group participant is randomised to.
The "Intervention" arm is aimed at specifically addressing gaps in terms of knowledge of colorectal cancer and the importance of screening, as well as targeting cost as well as convenience issues. Spouses who have been randomized into this arm will undergo a session with a trained research assistant who will highlight the following points:
- What is colorectal cancer and what are its risk factors?
- What is the spouse possibly at risk of developing colorectal cancer?
- How can screening help to reduce the risk of colorectal cancer?
- What are the screening modalities for CRC?
- What are FIT kits?
- How to use FIT kits?
- Where to return the FIT kits once they have been used?
All participants who have undergone the counseling session will then be given 2 x FIT kits (as recommended in the guidelines) free of charge, and also advised to mail the FIT kits back to the colorectal clinic in a pre-paid envelope once it has been used. By performing the above targeted interventions, we would have tackled issues relating to education, cost and convenience.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Has a partner who was diagnosed and treated for Colorectal Cancer
- •Either Singaporean or Permanent Resident;
- •Fulfilled the eligibility to undergo screening for colorectal cancer as stipulated by MOH.
排除标准
- •Pre-existing family history of FAP, HNPCC or inflammatory bowel disease in the family, as this would place the patient in the high risk group
- •Previous personal history of colorectal cancer or colorectal polyps
- •Underwent previous FOBT/FIT tests for CRC (this is an exclusion to participate in Stage 2-RCT only. Participants can still take part in Stage 1 and Stage 3 of the study if they fulfilled inclusion criteria 1-3, and did not meet any of the exclusion criteria 1-2)
研究组 & 干预措施
Current practice
"Intervention A" depicts current practices by informing the participants that FIT kits can be obtained from from the Singapore Cancer Society (SCS) or one of their collection point free of charge.
干预措施: Current practice (Behavioral)
Targeted intervention programme
"Intervention B" involves a targeted intervention programme tackling issues relating to a lack of education, inconvenience and cost would improve screening rates amongst the spouses.
干预措施: Targeted intervention programme (Behavioral)
结局指标
主要结局
The proportion of participants that completed the FIT test within three months post enrollment.
时间窗: 3 months
The research team would like to compare the percentage of FIT kit uptake rates amongst the two intervention arms. A positive outcome would be a higher percentage of FIT uptake seen in the targeted intervention arm.
次要结局
未报告次要终点
研究者
KER-KAN TAN
Assistant Professor Tan Ker Kan
National University Health System, Singapore