Engaging Patients in Colon Cancer Screening Decisions During COVID-19
Condition: Colon Cancer
MeSH terms: COVID-19; Colonic Neoplasms
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.

      The following hypotheses will be evaluated using an intention to treat approach, so patients
      will be analyzed based on their assigned arm.

      Hypothesis 1: Compared to the control group, patients in intervention arm will report higher
      shared decision making (primary outcome).

      Hypothesis 2: Compared to the control group, patients in the intervention arm will have (2a)
      stronger intention to follow through with colon cancer screening (whether colonoscopy,
      stool-based test or other approach) and (2b) will be more likely to have a screening test
      within 6 months.

      Hypothesis 3: Compared to the control group, patients in the intervention arm will have less
      decisional conflict (SURE score).
    

Intervention name(s): Shared Decision Making
Intervention type(s): Behavioral
Intervention description(s): The decision aid is a paper information sheet presenting the pros and cons of three screening options (colonoscopy, stool-based tests, and postponing cancer screening until next year).
The decision coaching is a structured interview to help patients clarify their preference for screening test and to support them in implementation (whether scheduling colonoscopy, ordering stool test or seeking additional advice from specialist).
Other intervention name(s): Decision aid; Decision coaching
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two-armed randomized control trial
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Shared Decision Making; Colon Cancer Screening; COVID-19