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临床试验/NCT04432870
NCT04432870已完成不适用

Patients' Preferences About Rescheduling Colonoscopies Delayed Due to COVID-19: Cross Sectional Study

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 203 人开始时间: 2020年6月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
203
试验地点
1
主要终点
Interest in colon cancer screening

研究概览

简要总结

The study is a cross-sectional survey study targeting patients aged 45-75 who had their screening or surveillance colonoscopy postponed or delayed due to the COVID pandemic. Study staff will survey a random subsample of patients to assess anxiety, COVID risk tolerance, cancer worry, willingness to screen and barriers to screening colonoscopy, and preference for colonoscopy and alternative colon cancer screening options.

Eligible patients will be sent a survey packet in the mail that will include a cover letter, an information sheet describing the study, an incentive, and the survey. The cover letter will include information for participants to opt-out if they desire. Patients will be asked to complete the survey and return it back to study staff. Consent is implied with return of the survey.

For the study, staff plan to invite 300 patients and expect to receive 195 completed surveys. Analyses will examine whether COVID-19 has changed patients' interest in colon cancer screening and the strength of patients' preferences for colonoscopy and other approaches to colon cancer screening. It will then examine factors associated with positive and negative views on rescheduling colonoscopies such as anxiety, worry, and risk perceptions.

详细描述

The study is a cross-sectional survey study targeting patients aged 45-75 who had their screening or surveillance colonoscopy postponed or delayed due to the COVID pandemic. Staff will survey a random subsample of patients to assess anxiety, COVID risk tolerance, cancer worry, willingness to screen and barriers to screening colonoscopy, and preference for colonoscopy and alternative colon cancer screening options.

Study staff will work with the gastroenterology department to identify patients whose colonoscopy has been delayed due to COVID-19 and who meet the eligibility criteria. A random sample of about 300 eligible patients will be selected for the survey study.

Eligible patients will be sent a survey packet in the mail that will include a cover letter, an information sheet describing the study, an incentive, and the survey. The cover letter will include information for participants to opt-out if they desire. Patients will be asked to complete the survey and return it back to study staff. Patients will also be able to complete the survey online via a RedCap link. Consent is implied with return of the completed survey. Staff will make up to three reminder phone calls and will send a reminder packet to non responders.

The study staff will invite 300 patients and expect to receive about 195 completed surveys.

Analyses will first examine whether there are differences between responders and non responders. Then, the analysis will examine descriptive statistics exploring patients' interest in colon cancer screening, strength of preference for switching to stool based testing or postponing colonoscopy for a year. The analyses will explore patients' perspective towards colonoscopy in the coming months and factors associated with positive or negative perceptions of colonoscopy such as anxiety, cancer worry, COVID worry and risk perceptions. The relationships between these factors will be examined using chi-square analysis (for categorical data) and correlations (for continuous data). Models will be used to explore factors associated with different preferences for screening.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
45 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults, age 45-75
  • Had screening or surveillance colonoscopy delayed due to COVID-19
  • Either first screening colonoscopy or a routine screening or surveillance colonoscopy for low to moderate risk patients (as indicated by 3-10 year recommended follow up frequency from prior test)

排除标准

  • Diagnostic colonoscopy
  • High risk for colorectal cancer as indicated by 1 year follow up schedule
  • Prior history of colon cancer or irritable bowel syndrome
  • Unable to read or write in English or Spanish

结局指标

主要结局

Interest in colon cancer screening

时间窗: at start of study--between one week and 2 months after start of study

Item with 5-point response assessing whether COVID-19 has increased, decreased or not changed interest in colon cancer screening

次要结局

  • Preference for stool testing(at start of study--between one week and 2 months after start of study)
  • Risk perception on COVID-19(at start of study--between one week and 2 months after start of study)
  • Preference for postponing colonoscopy for one year(at start of study--between one week and 2 months after start of study)
  • Worry about delay(at start of study--between one week and 2 months after start of study)

研究者

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

Karen Sepucha

Director of the Health Decision Sciences Center

Massachusetts General Hospital

研究点 (1)

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