Patients' Preferences About Rescheduling Colonoscopies Delayed Due to COVID-19: Cross Sectional Study

Colon Cancer Clinical Trial

Official title:

Patients' Preferences About Rescheduling Colonoscopies Delayed Due to COVID-19: Cross Sectional Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04432870
• Other study ID #: 2020P001579-1
• Status: Completed
• Start date: June 9, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: August 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

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. 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.

Study staff will work with the gastroenterology department to identify patients whose colonoscopy has been delayed due to COVID-19 and who meet the eligibility criteria. A random sample of about 300 eligible patients will be selected for the survey study.

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. Patients will also be able to complete the survey online via a RedCap link. Consent is implied with return of the completed survey. Staff will make up to three reminder phone calls and will send a reminder packet to non responders.

The study staff will invite 300 patients and expect to receive about 195 completed surveys.

Analyses will first examine whether there are differences between responders and non responders. Then, the analysis will examine descriptive statistics exploring patients' interest in colon cancer screening, strength of preference for switching to stool based testing or postponing colonoscopy for a year. The analyses will explore patients' perspective towards colonoscopy in the coming months and factors associated with positive or negative perceptions of colonoscopy such as anxiety, cancer worry, COVID worry and risk perceptions. The relationships between these factors will be examined using chi-square analysis (for categorical data) and correlations (for continuous data). Models will be used to explore factors associated with different preferences for screening.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: June 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Preference for stool testing	Item with 5-point response (definitely want to definitely do not want) measuring interest in having a stool test for colon cancer	at start of study--between one week and 2 months after start of study
Secondary	Preference for postponing colonoscopy for one year	Item with 5-point response (definitely want to definitely do not want) measuring interest in postponing colonoscopy for one year	at start of study--between one week and 2 months after start of study
Secondary	Worry about delay	Item with 5 point response (extremely worried to not at all worried) assessing worry about the delay of the colonoscopy on their colon cancer risk	at start of study--between one week and 2 months after start of study
Secondary	Risk perception on COVID-19	Item with 5-point response (very high to very low) assessing patients' perception about risk of getting COVID-19 from having a colonoscopy	at start of study--between one week and 2 months after start of study