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临床试验/NCT03253822
NCT03253822已完成不适用

The Effect of a Colorectal Cancer Screening Decision Aid Tailored for People With Lower Educational Attainment in the Central Denmark Region on Colorectal Cancer Knowledge and Colorectal Cancer Screening Attitude and Participation Rate

University of Aarhus2 个研究点 分布在 1 个国家目标入组 15,030 人开始时间: 2017年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
15,030
试验地点
2
主要终点
CRC screening attitude

研究概览

简要总结

The aim of the trial is to test the effect of a web-based decision aid (DA) on colorectal cancer (CRC) knowledge, decisional conflict, participation rate, and informed choice (evaluated based on knowledge, attitudes and actual participation).

The study includes three study arms. Citizens to be recruited are identified from the Danish Civil Registration System based on residence (Central Denmark Region), age (50-74 years old), and month of birth. A random sample of 15,000 citizens born in December (invited for CRC screening through October/November/December 2017) (study arm 1+2) and 5,000 citizens born in October (invited for CRC screening in January/February 2017) (study arm 3) is identified.

Citizens in study arm 1+2 will receive a baseline questionnaire assessing knowledge, attitudes, worry, and health literacy. Non respondents will receive one reminder after two weeks and after four weeks non-respondents will receive a phone call, offering them to fill out the questionnaire via the phone. Baseline questionnaire respondents are included in the study, and will be randomized into two study arms (intervention group and control group).

Citizens in the intervention group will be identified in the screening IT system. Date of screening invitation and screening reminder (citizens who do not return a stool sample within 45 days of the screening invitation) is retrieved. Citizens receiving a screening reminder will receive a link for the DA. Follow-up questionnaire will be sent to all included citizens in study-arm 1+2 three months after the last screening invitation has been sent out. Citizens have six weeks to respond to the questionnaire.

Study arm 3 is a historic cohort. The citizens receive only one questionnaire at the same time as the baseline questionnaires are sent out to the intervention and control groups. The citizens are included if they respond to the questionnaire within six weeks. Questionnaire reminders are sent out at two and four weeks.

Data on screening invitation date, screening reminder date, returning a stool sample and result will be retrieved from the screening IT system for all included citizens (Study arm 1-3). Lastly, data from Statistics Denmark (on socio-demographic and socio-economic factors) will be included.

详细描述

Study setting The Danish national colorectal cancer (CRC) screening programme was implemented in Denmark in March 2014. All citizens aged 50-74 years are invited to take up CRC screening biennially, however, the first prevalence round is carried out during a four year period (2014-2017). During the this period, citizens are invited according to month of birth, except citizens aged 49 who are invited just before they turn 50 and citizens turning 75 who are invited prior to their 75th birthday, if they were not invited earlier in the program.

Politically and organisationally the CRC screening programme is nationally directed, but the administrative responsibility is placed within the five regions in Denmark. The Department of Public Health Programmes is responsible for the administration of the CRC screening programme in the Central Denmark Region (CDR).

The CDR has 1.3 million citizens (23% of the total population) of which roughly 390 000 citizens are 50-74 years of age. The citizens receive an invitation, containing a screening kit. The screening test (collection of a stool sample) is performed in the citizen's own home. The stool sample is sent to the clinical biochemical department at the hospital. If the citizens do not return a stool sample within 45 days after receiving the invitation, a screening reminder is received. Citizens, who still do not return a stool sample, are automatically referred to the next screening round, and will receive another invitation two years later. Citizens with a negative test are automatically referred to the next screening round. Citizens with a positive test are invited to have a colonoscopy.

Since 2010, national digitisation has occurred in Denmark. Hence, communication to and from Danish authorities occur via digital mail, in the public email platform E-Boks. Danish residents are obliged to order a digital signature (NemID) which is used as a shared log-in for E-boks, public and private online self-services, and online banking. Only disabled citizens (e.g. physical or cognitive impairment) or citizens unable to satisfactorily identify themselves (e.g. migrants with no permanent resident permit) can be exempted from ordering a NemID. As of May 2016 more than 5 million Danish citizens (87.5% of the entire population including children) have access to E-boks. Exemption from digital communication has been granted to 9.8% of Danish Residents aged 45-74 years.

All letters in the CRC screening programme are sent by digital mail, except from invitation letters, which contains a screening kit and are sent by conventional mail. Citizens exempt from digital communication receive conventional letters via a remote printing system.

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
None

盲法说明

Since baseline questionnaire is filled out before randomizasion, and citizens will know if they receive the DA or not, participants will not be masked.

No care providers are involved in the screening program in the phases we study (invitation, reminder, and stool sample), hence no masking in this groups.

The outcomes are assessed via questionnaire data or from registries (Statistics Denmark and the screening IT system), and no masking is necessary in neither investigators nor outcomes assessors.

入排标准

年龄范围
50 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Random sample of citizens 50-74 years of age.
  • Resident in the Central Denmark Region at time of data extraction (August 2017)
  • Month of birth: December or October

排除标准

  • Non-respondents to baseline questionnaire (study arm 1+2) or questionnaire (study arm 3)

研究组 & 干预措施

Intervention group

Experimental

This group receives a baseline questionnaire before their screening invitation. Respondents are included, and those receiving a screening reminder receive the decision aid.

At least three months after their screening invitation the included citizens (baseline questionnaire respondents) will receive a follow-up questionnaire.

干预措施: Decision aid (Other)

Control group

No Intervention

This group receives a baseline questionnaire before their screening invitation. Respondents are included. At least three months after their screening invitation, baseline questionnaire respondents will receive a follow-up questionnaire.

Historic cohort

No Intervention

A group of people already invited for colorectal cancer screening. This group receives a questionnaire at least three months after their screening invitation. Respondents are included in the study.

结局指标

主要结局

CRC screening attitude

时间窗: Assessed before screening invitation (study arm 1+2) and at least three months after screening invitation (study arm 1+2+3)

Assessed using questionnaire. Four items. Scores between 7 and 28. Continuous variable.

CRC and CRC screening knowledge

时间窗: Assessed before screening invitation (study arm 1+2) and at least three months after screening invitation (study arm 1+2+3)

Assessed using questionnaire. Six items yielding a scale score between 0 and 100 %. Continous variable.

CRC screening participation

时间窗: Obtained at least three months after screening invitation.

Binary outcome (yes/no), retrieved from screening IT system.

次要结局

  • Ethnicity(Up to 12 months before screening invitation)
  • Educational level(Up to 12 months before screening invitation)
  • Occupation(Up to 12 months before screening invitation)
  • CRC worry(Assessed before screening invitation (study arm 1+2) and at least three months after screening invitation (study arm 1+2+3))
  • Decisional conflict(Assessed at least three months after invitation (study arm 1+2+3))
  • Health literacy(Assessed before screening invitation (study arm 1+2) or at least three months after screening invitation (study arm 3))
  • Family income(Up to 12 months before screening invitation)
  • Marital status(Up to 12 months before screening invitation)

研究者

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

Pernille Gabel

M.D. PhD Fellow

University of Aarhus

研究点 (2)

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