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临床试验/NCT04548531
NCT04548531已完成不适用

Engaging Patients in Colon Cancer Screening Decisions During COVID-19

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2020年9月10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
800
试验地点
2
主要终点
Shared Decision Making (SDM) Process Scale Score

研究概览

简要总结

The goal of the study is to examine whether a shared decision making intervention improves decision making about colon cancer screening for patients who had their colonoscopy delayed or postponed due to the COVID pandemic. Eligible patients (n=800) will be randomly assigned to either the intervention or control arm. A subset will be surveyed about 6-8 weeks post intervention to measure shared decision making, their intention to follow through with screening, and their decisional conflict. Study staff will conduct medical chart review to track receipt of colon cancer screening within 6 months. The statistician will test whether patients in the intervention arm report more shared decision making, less decisional conflict, higher intention to follow through on screening and have higher screening rates compared to those in the control arm.

详细描述

The goal of the study is to examine whether a shared decision making intervention improves decision making about colon cancer screening for patients who had their colonoscopy delayed or postponed due to the COVID pandemic. Eligible patient (n=800) will randomly assigned to either the intervention or control arm. A subset will be surveyed about 6-8 weeks post intervention to determine the extent to which they report shared decision making, their intention to follow through with screening, and their decisional conflict. Study staff will also conduct medical chart review to track receipt of colon cancer screening within 6 months.

Intervention arm: In this arm, patients will get a shared decision making information sheet in the mail that describes three screening options: (1) schedule next available colonoscopy, (2) switch to a stool-based test, and (3) delay colonoscopy for a year. Study staff trained in decision coaching will follow up with patients to help them select an option and support implementation.

Control arm: This arm will be a usual care arm. The gastroenterology department department has schedulers calling patients and texting patients to schedule their procedure.

All 800 patients will be followed for their cancer screening outcomes, and a subset n=460 or 230 in each arm will be randomly selected to receive the survey.

Study staff who prepare the intervention mailing and the surveys will not be blinded to the study arm. The staff who enter the data from the paper surveys and who conduct chart review to collect screening will be blinded to the assignment. The statistician analyzing the results will also be blinded to the assignment.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

盲法说明

Patients will not be given any information on their assigned arm. Statistician will be blinded to the assignment when analyzing the results.

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 or cancelled from March-June 2020

排除标准

  • Diagnostic colonoscopy
  • High risk for colorectal cancer as indicated by 1 year follow up schedule
  • Prior history of colon cancer
  • Unable to read or write in English or Spanish
  • Have already scheduled or completed a colonoscopy since restrictions were lifted

结局指标

主要结局

Shared Decision Making (SDM) Process Scale Score

时间窗: About 8 weeks after intervention

short patient reported scale asks patients about discussion of options, pros and cons of colonoscopy and discussion of patients' preferences. Total scores range from 0-4 with higher scores indicating higher shared decision making.

次要结局

  • No Decisional Conflict (Number With Score of 4 on SURE Scale)(About 8 weeks after intervention)
  • Patient's Preferred Approach to Screening(About 8 weeks after intervention)
  • Colon Cancer Screening Rate(6 months after randomization)
  • Number Reporting "Very Likely" to Follow Through With Screening(About 8 weeks after intervention)

研究者

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

Karen Sepucha

Director of Health Decision Sciences Center

Massachusetts General Hospital

研究点 (2)

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