Patients' Preferences About Rescheduling Colonoscopies Delayed Due to COVID-19: Cross Sectional Study
1 other identifier
observational
203
1 country
1
Brief Summary
The study is a cross-sectional survey study targeting patients aged 45-75 who had their screening or surveillance colonoscopy postponed or delayed due to the COVID pandemic. Study staff will survey a random subsample of patients to assess anxiety, COVID risk tolerance, cancer worry, willingness to screen and barriers to screening colonoscopy, and preference for colonoscopy and alternative colon cancer screening options. Eligible patients will be sent a survey packet in the mail that will include a cover letter, an information sheet describing the study, an incentive, and the survey. The cover letter will include information for participants to opt-out if they desire. Patients will be asked to complete the survey and return it back to study staff. Consent is implied with return of the survey. For the study, staff plan to invite 300 patients and expect to receive 195 completed surveys. Analyses will examine whether COVID-19 has changed patients' interest in colon cancer screening and the strength of patients' preferences for colonoscopy and other approaches to colon cancer screening. It will then examine factors associated with positive and negative views on rescheduling colonoscopies such as anxiety, worry, and risk perceptions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 9, 2020
CompletedFirst Submitted
Initial submission to the registry
June 12, 2020
CompletedFirst Posted
Study publicly available on registry
June 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedSeptember 1, 2021
August 1, 2021
12 months
June 12, 2020
August 31, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Interest in colon cancer screening
Item with 5-point response assessing whether COVID-19 has increased, decreased or not changed interest in colon cancer screening
at start of study--between one week and 2 months after start of study
Secondary Outcomes (4)
Preference for stool testing
at start of study--between one week and 2 months after start of study
Preference for postponing colonoscopy for one year
at start of study--between one week and 2 months after start of study
Worry about delay
at start of study--between one week and 2 months after start of study
Risk perception on COVID-19
at start of study--between one week and 2 months after start of study
Study Arms (1)
MGH Patients
Patients aged 45-75 who had their screening or surveillance colonoscopy postponed or delayed due to the COVID pandemic at Massachusetts General Hospital
Eligibility Criteria
Adult patients aged 45-75 who had their colonoscopy delayed or postponed due to the COVID-19 pandemic.
You may qualify if:
- Adults, age 45-75
- Had screening or surveillance colonoscopy delayed due to COVID-19
- Either first screening colonoscopy or a routine screening or surveillance colonoscopy for low to moderate risk patients (as indicated by 3-10 year recommended follow up frequency from prior test)
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 or irritable bowel syndrome
- Unable to read or write in English or Spanish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karen Sepucha, PhD
Massachusetts General Hospital
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of the Health Decision Sciences Center
Study Record Dates
First Submitted
June 12, 2020
First Posted
June 16, 2020
Study Start
June 9, 2020
Primary Completion
May 30, 2021
Study Completion
June 30, 2021
Last Updated
September 1, 2021
Record last verified: 2021-08
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.
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.