Clinical trial NCT04548531: Engaging Patients in Colon Cancer Screening Decisions During COVID-19
Official title: Engaging Patients in Colon Cancer Screening Decisions During COVID-19
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Cancer
Keywords: Shared Decision Making
Colon Cancer Screening
COVID-19
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2020-09-14
Enrollment: 800
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-armed randomized control trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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).

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

Primary outcomes:
measure: Shared Decision Making (SDM) Process Scale Score
timeFrame: About 8 weeks after intervention
Secondary outcomes:
measure: No Decisional Conflict (Number With Score of 4 on SURE Scale)
timeFrame: About 8 weeks after intervention
measure: Patient's Preferred Approach to Screening
timeFrame: About 8 weeks after intervention
measure: Number Reporting "Very Likely" to Follow Through With Screening
timeFrame: About 8 weeks after intervention
measure: Colon Cancer Screening Rate
timeFrame: 6 months after randomization
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Karen Sepucha, PhD
role: PRINCIPAL_INVESTIGATOR
References: