Engaging Patients in Colon Cancer Screening Decisions During COVID-19
1 other identifier
interventional
800
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2020
CompletedStudy Start
First participant enrolled
September 10, 2020
CompletedFirst Posted
Study publicly available on registry
September 14, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2021
CompletedResults Posted
Study results publicly available
February 22, 2023
CompletedFebruary 22, 2023
May 1, 2022
8 months
September 9, 2020
April 13, 2022
May 19, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Shared Decision Making (SDM) Process Scale Score
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.
About 8 weeks after intervention
Secondary Outcomes (4)
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
Number Reporting "Very Likely" to Follow Through With Screening
About 8 weeks after intervention
Colon Cancer Screening Rate
6 months after randomization
Study Arms (2)
Usual Care Arm
NO INTERVENTIONThis arm will be a usual care arm. Patients may call to schedule a colonoscopy or other tests as desired.
Shared Decision Making Arm
EXPERIMENTALThis is the intervention arm. Patients will receive a shared decision making information sheet in the mail and will be able to receive decision coaching from study staff to support selection of an option if desired.
Interventions
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).
Eligibility Criteria
You may qualify if:
- Adults, age 45-75
- Had screening or surveillance colonoscopy delayed or cancelled from March-June 2020
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Karen Sepucha
- Organization
- Massachusetts General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Sepucha, PhD
Massachusetts General Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Patients will not be given any information on their assigned arm. Statistician will be blinded to the assignment when analyzing the results.
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Health Decision Sciences Center
Study Record Dates
First Submitted
September 9, 2020
First Posted
September 14, 2020
Study Start
September 10, 2020
Primary Completion
April 30, 2021
Study Completion
April 30, 2021
Last Updated
February 22, 2023
Results First Posted
February 22, 2023
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- Three months after the end of the funded grant period, the study materials and de-identified data will be available, by request, from the PI. Once data are placed on an open access service such as ICPSR they will be available indefinitely.
- Access Criteria
- The PI will share a de-identified data set with outside investigators at no cost, according to approved Partners and Massachusetts General Hospital policies for data sharing. Investigators from other sites will be able to request the data and will be required to complete a data use agreement that ensures that all local Institutional Review Board requirements are met before using the data, that they will not attempt to identify any data in the dataset, and that they will not share the data set with anyone outside their project team. On ICPSR, individuals must register and agree to ICPSR's Responsible Use statement prior to accessing datasets.
Yes To promote research replicability, transparency and future use of the data, de-identified data sets of the patient survey data will be created and will be available, by request, to outside researchers. After the main manuscripts have been published, de-identified data sets will also be deposited in an open access service such as, ICPSR (https://www.icpsr.umich.edu/icpsrweb/). Before a dataset is made available for access, ICPSR completes a detailed review of all datasets to assess disclosure risk. If necessary, ICPSR modifies data to reduce disclosure risk or limits access to datasets for which modifying the data would substantially limit their utility or the risk of disclosure remains high. No information that contains identifiers or that could be used to link an individual to the data will be included in the de-identified data set.