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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04432870
Collaborator
Patient-Centered Outcomes Research Institute (Other)
203
1
12.7
16

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    203 participants
    Observational Model:
    Other
    Time Perspective:
    Cross-Sectional
    Official Title:
    Patients' Preferences About Rescheduling Colonoscopies Delayed Due to COVID-19: Cross Sectional Study
    Actual Study Start Date :
    Jun 9, 2020
    Actual Primary Completion Date :
    May 30, 2021
    Actual Study Completion Date :
    Jun 30, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Interest in colon cancer screening [at start of study--between one week and 2 months after start of study]

      Item with 5-point response assessing whether COVID-19 has increased, decreased or not changed interest in colon cancer screening

    Secondary Outcome Measures

    1. Preference for stool testing [at start of study--between one week and 2 months after start of study]

      Item with 5-point response (definitely want to definitely do not want) measuring interest in having a stool test for colon cancer

    2. Preference for postponing colonoscopy for one year [at start of study--between one week and 2 months after start of study]

      Item with 5-point response (definitely want to definitely do not want) measuring interest in postponing colonoscopy for one year

    3. Worry about delay [at start of study--between one week and 2 months after start of study]

      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

    4. Risk perception on COVID-19 [at start of study--between one week and 2 months after start of study]

      Item with 5-point response (very high to very low) assessing patients' perception about risk of getting COVID-19 from having a colonoscopy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    45 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Massachusetts General Hospital Boston Massachusetts United States 02114

    Sponsors and Collaborators

    • Massachusetts General Hospital
    • Patient-Centered Outcomes Research Institute

    Investigators

    • Principal Investigator: Karen Sepucha, PhD, Massachusetts General Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Karen Sepucha, Director of the Health Decision Sciences Center, Massachusetts General Hospital
    ClinicalTrials.gov Identifier:
    NCT04432870
    Other Study ID Numbers:
    • 2020P001579-1
    First Posted:
    Jun 16, 2020
    Last Update Posted:
    Sep 1, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Karen Sepucha, Director of the Health Decision Sciences Center, Massachusetts General Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 1, 2021