Clinical trial NCT04432870: Patients' Preferences About Rescheduling Colonoscopies Delayed Due to COVID-19: Cross Sectional Study
Official title: Patients' Preferences About Rescheduling Colonoscopies Delayed Due to COVID-19: Cross Sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colon Cancer
Keywords: shared decision making
colon cancer screening
COVID-19
waitlist
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2020-06-16
Enrollment: 203
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients aged 45-75 who had their colonoscopy delayed or postponed due to the COVID-19 pandemic.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Interest in colon cancer screening
timeFrame: at start of study--between one week and 2 months after start of study
Secondary outcomes:
measure: Preference for stool testing
timeFrame: at start of study--between one week and 2 months after start of study
measure: Preference for postponing colonoscopy for one year
timeFrame: at start of study--between one week and 2 months after start of study
measure: Worry about delay
timeFrame: at start of study--between one week and 2 months after start of study
measure: Risk perception on COVID-19
timeFrame: at start of study--between one week and 2 months after start of study
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: