跳至主要内容
临床试验/NCT04348058
NCT04348058Unknown不适用

Telephone Services for Participation Improvement in Colorectal Cancer Screening: a Randomized Health Services Study

Maria Sklodowska-Curie National Research Institute of Oncology2 个研究点 分布在 1 个国家目标入组 6,300 人开始时间: 2020年8月20日最近更新:
适应症

试验速览

阶段
不适用
入组人数
6,300
试验地点
2
主要终点
Participation rate to screening colonoscopy within PCSP per recruitment strategy

研究概览

简要总结

A multicentre randomized health services study within the population-based primary colonoscopy screening program (PCSP) in Poland. Individuals, aged 55-60 years, willl be randomized in a 1:1:1 ratio to arms: (1) Invitation by post, (2) Call Center or (2) Combined invitation methods. The primary outcome measure is rate of participation in screening colonoscopy. The sample size of 6 300 participants will detect 3 to 5 percentage point differences (depending on the arms comparison) in participation rate between groups with 80% power and significance level 0.05, using Ochran-Mantel-Haenszel test.

详细描述

This randomized health services study will be performed within national population-based screening program (PCSP) in Poland, including its population, infrastructure and database system.

Individuals aged 55-64 years old, included in PCSP willl be randomly assigned (in 1:1:1 ratio, stratified by gender, age, place of residence) to study arms and invited to screening colonoscopy to local PSCP centers.

Invitation process by post in Control group (1) and partially in Combined group (3) - will be performed by coordinating PCSP center (practice as usual).

Recruitment by telephone conversation in Call Center group (2) and partially in Combined group (3) - will be performed by Screening Up call center company. Colonoscopies will be performed in 6 selected PCSP centers.

The sample size of 2,100 participants per group (350 participants from each group in each center, assuming 5% drop out and access to telephone numbers of 30% participants in relevant arms; calculation is based on a 95% confidence interval +/- 5% error probability) was calculated to detect a difference in participation rate of 15% in control group (based on PCSP participation rate in 2019) vs. 18.7% in Call Center group vs 25% in Combined Invitation group (0.025 significance level with 80% power). The difference was calculated for the Cochran-Mantel-Haenszel test, assuming that the initial reporting in the control group will be as high as it was in 2019.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
55 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • population included to invitation within Polish population based Colorectal cancer Screening Program (PCSP)
  • 55-64 of age
  • no history of CRC
  • no history of screening colonoscopy within PCSP
  • adress of residence near (not further than 40 kilometers) local PCSP centers (selected for the study based on population density)

排除标准

  • 未提供

结局指标

主要结局

Participation rate to screening colonoscopy within PCSP per recruitment strategy

时间窗: 26 weeks after intervention

The percentage of study participants who underwent screening colonoscopy relative to all PCSP participants to whom the invitation was sent in a given group during the observation period (intention-to-screen analysis)

次要结局

  • Response rate to invitation to screening colonoscopy(26 weeks after intervention)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marek Bugajski

PhD, MD, Principal Investigator

Maria Sklodowska-Curie National Research Institute of Oncology

研究点 (2)

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