Effectiveness of a Brief Telephone Intervention to Improve Participation in a Colorectal Cancer Screening Program: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 432
- 试验地点
- 2
- 主要终点
- Participation
研究概览
简要总结
Objective: To assess the effectiveness of a brief telephone intervention added to an post invitation letter in the participation rate to a colorectal cancer screening program.
Methods: Randomized controlled trial. This study is framed inside the colorectal cancer screening program of Catalonia, concretely in the region of Vallès Occidental. This program is directed to men and women from 50 to 69 years. The screening test used is the fecal immunological test (FIT) that is offered every 2 years. If the screening test is positive, a colonoscopy with sedation is offered as a diagnostic test.
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
- 49 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women and men from 50 to 69 years living in the selected territories (Terrassa C, Terrassa A, Cerdanyola del Vallès 1) that will be invited for the first time in the Colorectal cancer screening program.
排除标准
- •The same as those used in the population program:
- •History of colorectal cancer;
- •History of inflammatory bowel disease;
- •history of colorectal adenomas;
- •family history of polyposis syndromes or hereditary nonpolyposis colorectal cancer;
- •family history of colorectal cancer if: two first grade relatives affected or only one fist grade relative affected diagnosed before the age of 60;
- •terminal illness or severe disability which contraindicates the study of the colon. People is excluded temporally if:
- •they have a colonoscopy performed in the last 5 years;
- •present digestive signs or symptoms (rectal bleeding, change in bowel habits, abdominal pain, weight loss with fatigue and anorexia, abdominal mass);
- •they express the will to be out of the Program.
研究组 & 干预措施
Phone call
A brief telephone intervention at the same time of sending the invitation letter plus the habitual invitation process used in the screening program (described in control group).
Calls will be made by the administrative staff of the Screening Technical Office, which is experienced in telephone attention.
Each phone call will last approximately 5 minutes.
干预措施: Phone call (Other)
Phone call
A brief telephone intervention at the same time of sending the invitation letter plus the habitual invitation process used in the screening program (described in control group).
Calls will be made by the administrative staff of the Screening Technical Office, which is experienced in telephone attention.
Each phone call will last approximately 5 minutes.
干预措施: Invitation letter (Other)
Standard procedure
The habitual invitation strategy used in the screening program . Three letters are send by post: 1- An invitation letter plus an information leaflet and a list of pharmacies in which people can obtain the screening test. 2- A reminder letter for those who have not participated after 5 weeks of sending the first letter. 3- A second reminder letter for those who have collected the kit in the pharmacy but have not returned it with the sample.
干预措施: Invitation letter (Other)
结局指标
主要结局
Participation
时间窗: 6 months
Participation is defined as the number of people who do the screening test to the total of people invited to the Program.
次要结局
- Knowledge of the program(1 day at the time of intervention administration)
- Comprehension of the information received(1 day at the time of intervention administration)
- Help to decide about participation(1 day at the time of intervention administration)
研究者
Anna Selva
Medical doctor specialist in Preventive Medicine and Public Health
Corporacion Parc Tauli