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Engaging Patients in Colon Cancer Screening Decisions During COVID-19

NCT04548531 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 800

Last updated 2023-02-22

Study results available
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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.

Conditions

Interventions

BEHAVIORAL

Shared Decision Making

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).

Sponsors & Collaborators

  • Patient-Centered Outcomes Research Institute

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Karen Sepucha, PhD · Massachusetts General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-10
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04548531 on ClinicalTrials.gov