Engaging Patients in Colon Cancer Screening Decisions During COVID-19
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Colon Cancer
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 800
- Locations
- 1
- Primary Endpoint
- Shared Decision Making (SDM) Process Scale Score
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief 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).
Investigators
Karen Sepucha
Director of Health Decision Sciences Center
Massachusetts General Hospital
Eligibility Criteria
Inclusion Criteria
- •Adults, age 45-75
- •Had screening or surveillance colonoscopy delayed or cancelled from March-June 2020
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Shared Decision Making (SDM) Process Scale Score
Time Frame: 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.
Secondary Outcomes
- 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)