<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04432870</url>
  </required_header>
  <id_info>
    <org_study_id>2020P001579-1</org_study_id>
    <nct_id>NCT04432870</nct_id>
  </id_info>
  <brief_title>Patients' Preferences About Rescheduling Colonoscopies Delayed Due to COVID-19: Cross Sectional Study</brief_title>
  <official_title>Patients' Preferences About Rescheduling Colonoscopies Delayed Due to COVID-19: Cross Sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patient-Centered Outcomes Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study is a cross-sectional survey study targeting patients aged 45-75 who had their&#xD;
      screening or surveillance colonoscopy postponed or delayed due to the COVID pandemic. Study&#xD;
      staff will survey a random subsample of patients to assess anxiety, COVID risk tolerance,&#xD;
      cancer worry, willingness to screen and barriers to screening colonoscopy, and preference for&#xD;
      colonoscopy and alternative colon cancer screening options.&#xD;
&#xD;
      Eligible patients will be sent a survey packet in the mail that will include a cover letter,&#xD;
      an information sheet describing the study, an incentive, and the survey. The cover letter&#xD;
      will include information for participants to opt-out if they desire. Patients will be asked&#xD;
      to complete the survey and return it back to study staff. Consent is implied with return of&#xD;
      the survey.&#xD;
&#xD;
      For the study, staff plan to invite 300 patients and expect to receive 195 completed surveys.&#xD;
      Analyses will examine whether COVID-19 has changed patients' interest in colon cancer&#xD;
      screening and the strength of patients' preferences for colonoscopy and other approaches to&#xD;
      colon cancer screening. It will then examine factors associated with positive and negative&#xD;
      views on rescheduling colonoscopies such as anxiety, worry, and risk perceptions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a cross-sectional survey study targeting patients aged 45-75 who had their&#xD;
      screening or surveillance colonoscopy postponed or delayed due to the COVID pandemic. Staff&#xD;
      will survey a random subsample of patients to assess anxiety, COVID risk tolerance, cancer&#xD;
      worry, willingness to screen and barriers to screening colonoscopy, and preference for&#xD;
      colonoscopy and alternative colon cancer screening options.&#xD;
&#xD;
      Study staff will work with the gastroenterology department to identify patients whose&#xD;
      colonoscopy has been delayed due to COVID-19 and who meet the eligibility criteria. A random&#xD;
      sample of about 300 eligible patients will be selected for the survey study.&#xD;
&#xD;
      Eligible patients will be sent a survey packet in the mail that will include a cover letter,&#xD;
      an information sheet describing the study, an incentive, and the survey. The cover letter&#xD;
      will include information for participants to opt-out if they desire. Patients will be asked&#xD;
      to complete the survey and return it back to study staff. Patients will also be able to&#xD;
      complete the survey online via a RedCap link. Consent is implied with return of the completed&#xD;
      survey. Staff will make up to three reminder phone calls and will send a reminder packet to&#xD;
      non responders.&#xD;
&#xD;
      The study staff will invite 300 patients and expect to receive about 195 completed surveys.&#xD;
&#xD;
      Analyses will first examine whether there are differences between responders and non&#xD;
      responders. Then, the analysis will examine descriptive statistics exploring patients'&#xD;
      interest in colon cancer screening, strength of preference for switching to stool based&#xD;
      testing or postponing colonoscopy for a year. The analyses will explore patients' perspective&#xD;
      towards colonoscopy in the coming months and factors associated with positive or negative&#xD;
      perceptions of colonoscopy such as anxiety, cancer worry, COVID worry and risk perceptions.&#xD;
      The relationships between these factors will be examined using chi-square analysis (for&#xD;
      categorical data) and correlations (for continuous data). Models will be used to explore&#xD;
      factors associated with different preferences for screening.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 9, 2020</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">May 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Interest in colon cancer screening</measure>
    <time_frame>at start of study--between one week and 2 months after start of study</time_frame>
    <description>Item with 5-point response assessing whether COVID-19 has increased, decreased or not changed interest in colon cancer screening</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Preference for stool testing</measure>
    <time_frame>at start of study--between one week and 2 months after start of study</time_frame>
    <description>Item with 5-point response (definitely want to definitely do not want) measuring interest in having a stool test for colon cancer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preference for postponing colonoscopy for one year</measure>
    <time_frame>at start of study--between one week and 2 months after start of study</time_frame>
    <description>Item with 5-point response (definitely want to definitely do not want) measuring interest in postponing colonoscopy for one year</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Worry about delay</measure>
    <time_frame>at start of study--between one week and 2 months after start of study</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Risk perception on COVID-19</measure>
    <time_frame>at start of study--between one week and 2 months after start of study</time_frame>
    <description>Item with 5-point response (very high to very low) assessing patients' perception about risk of getting COVID-19 from having a colonoscopy</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">203</enrollment>
  <condition>Colon Cancer</condition>
  <arm_group>
    <arm_group_label>MGH Patients</arm_group_label>
    <description>Patients aged 45-75 who had their screening or surveillance colonoscopy postponed or delayed due to the COVID pandemic at Massachusetts General Hospital</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Adult patients aged 45-75 who had their colonoscopy delayed or postponed due to the&#xD;
        COVID-19 pandemic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults, age 45-75&#xD;
&#xD;
          -  Had screening or surveillance colonoscopy delayed due to COVID-19&#xD;
&#xD;
          -  Either first screening colonoscopy or a routine screening or surveillance colonoscopy&#xD;
             for low to moderate risk patients (as indicated by 3-10 year recommended follow up&#xD;
             frequency from prior test)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnostic colonoscopy&#xD;
&#xD;
          -  High risk for colorectal cancer as indicated by 1 year follow up schedule&#xD;
&#xD;
          -  Prior history of colon cancer or irritable bowel syndrome&#xD;
&#xD;
          -  Unable to read or write in English or Spanish&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karen Sepucha, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>August 31, 2021</last_update_submitted>
  <last_update_submitted_qc>August 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Karen Sepucha</investigator_full_name>
    <investigator_title>Director of the Health Decision Sciences Center</investigator_title>
  </responsible_party>
  <keyword>shared decision making</keyword>
  <keyword>colon cancer screening</keyword>
  <keyword>COVID-19</keyword>
  <keyword>waitlist</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Colonic Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>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.&#xD;
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.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_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.</ipd_time_frame>
    <ipd_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.&#xD;
On ICPSR, individuals must register and agree to ICPSR's Responsible Use statement prior to accessing datasets.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04432870
org study id: 2020P001579-1
nct id: NCT04432870
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Other
time perspective: Cross-Sectional
measure: Interest in colon cancer screening
time frame: at start of study--between one week and 2 months after start of study
description: Item with 5-point response assessing whether COVID-19 has increased, decreased or not changed interest in colon cancer screening
measure: Preference for stool testing
time frame: at start of study--between one week and 2 months after start of study
description: Item with 5-point response (definitely want to definitely do not want) measuring interest in having a stool test for colon cancer
measure: Preference for postponing colonoscopy for one year
time frame: at start of study--between one week and 2 months after start of study
description: Item with 5-point response (definitely want to definitely do not want) measuring interest in postponing colonoscopy for one year
measure: Worry about delay
time frame: at start of study--between one week and 2 months after start of study
description: 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
measure: Risk perception on COVID-19
time frame: at start of study--between one week and 2 months after start of study
description: Item with 5-point response (very high to very low) assessing patients' perception about risk of getting COVID-19 from having a colonoscopy
arm group label: MGH Patients
description: Patients aged 45-75 who had their screening or surveillance colonoscopy postponed or delayed due to the COVID pandemic at Massachusetts General Hospital
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 45 Years
maximum age: 75 Years
healthy volunteers: No
last name: Karen Sepucha, PhD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Karen Sepucha
investigator title: Director of the Health Decision Sciences Center
mesh term: COVID-19
mesh term: Colonic Neoplasms
sharing ipd: Yes
ipd description: 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.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Analytic Code
ipd 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.
ipd 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.