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Opt-In Versus Opt-Out for Colorectal Cancer Screening Outreach

Primary Purpose

Cancer of the Colon

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Opt-In Outreach
Opt-Out Outreach
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Cancer of the Colon

Eligibility Criteria

50 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Between 50 to 74 years old
  • Has received care at the Division of Internal Medicine
  • Due for screening
  • Asymptomatic for colorectal cancer (CRC)

Exclusion Criteria:

  • Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and fecal occult blood test (FOBT)/FIT within twelve months of the chart review (We will exclude patients who self-report undergoing any of the above procedures)
  • Has a history of CRC
  • Has a history of other GI cancer
  • Has history of confirmed Inflammatory Bowel Disease (IBD) (e.g. Crohn's disease, ulcerative colitis; Irritable bowel syndrome does not exclude patients)
  • Has history of colitis other than Crohn's disease or ulcerative colitis
  • Has had a colectomy
  • Has a relative that has been diagnosed with CRC
  • Has been diagnosed with Lynch Syndrome (i.e. HNPCC)
  • Has been diagnosed with Familial Adenomatous Polyposis (FAP)
  • Has iron deficiency anemia
  • Has history of lower GI bleeding
  • Has metastatic (Stage IV) blood or solid tumor cancer
  • Has end stage renal disease
  • Has cirrhosis
  • Has heart failure
  • Has dementia
  • Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Opt-In

    Opt-Out

    Arm Description

    Opt-In Outreach

    Opt-Out Outreach

    Outcomes

    Primary Outcome Measures

    FIT Completion Rate
    The percentage of participants who successfully complete the FIT.

    Secondary Outcome Measures

    Mail/Electronic Message Engagement
    The percentage of people who send responses using either mail or electronic messaging.

    Full Information

    First Posted
    October 7, 2016
    Last Updated
    May 22, 2020
    Sponsor
    University of Pennsylvania
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02929186
    Brief Title
    Opt-In Versus Opt-Out for Colorectal Cancer Screening Outreach
    Official Title
    Opt-In Versus Opt-Out for Colorectal Cancer Screening Outreach
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    June 15, 2017 (Actual)
    Study Completion Date
    November 15, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Pennsylvania

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This is a randomized controlled pilot study aimed at testing different outreach strategies (opt-in versus opt-out) to increase colorectal cancer screening through completion of mailed home fecal immunohistochemical testing (FIT).
    Detailed Description
    This is a randomized controlled pilot study aimed at testing different outreach strategies to increase colorectal cancer screening using mailed fecal immunohistochemical testing (FIT). The investigators will randomize a cohort of subjects between the ages of 50-74 into 2 arms: Opt-In - subject must actively choose to receive a home FIT kit. Opt-Out - a FIT kit is sent as a default unless the subject actives chooses not to receive the kit or reports prior screening.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cancer of the Colon

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    314 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Opt-In
    Arm Type
    Experimental
    Arm Description
    Opt-In Outreach
    Arm Title
    Opt-Out
    Arm Type
    Experimental
    Arm Description
    Opt-Out Outreach
    Intervention Type
    Behavioral
    Intervention Name(s)
    Opt-In Outreach
    Intervention Description
    Subjects will receive a communication (mail or electronic) describing the importance of colorectal cancer screening with the option to elect to receive a home FIT kit or report prior screening.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Opt-Out Outreach
    Intervention Description
    Subjects will receive a communication (mail or electronic) describing the importance of colorectal cancer screening with the option to choose not to receive a home FIT kit or report prior screening. A FIT kit will otherwise be sent to the subject as a default.
    Primary Outcome Measure Information:
    Title
    FIT Completion Rate
    Description
    The percentage of participants who successfully complete the FIT.
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    Mail/Electronic Message Engagement
    Description
    The percentage of people who send responses using either mail or electronic messaging.
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    74 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Between 50 to 74 years old Has received care at the Division of Internal Medicine Due for screening Asymptomatic for colorectal cancer (CRC) Exclusion Criteria: Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and fecal occult blood test (FOBT)/FIT within twelve months of the chart review (We will exclude patients who self-report undergoing any of the above procedures) Has a history of CRC Has a history of other GI cancer Has history of confirmed Inflammatory Bowel Disease (IBD) (e.g. Crohn's disease, ulcerative colitis; Irritable bowel syndrome does not exclude patients) Has history of colitis other than Crohn's disease or ulcerative colitis Has had a colectomy Has a relative that has been diagnosed with CRC Has been diagnosed with Lynch Syndrome (i.e. HNPCC) Has been diagnosed with Familial Adenomatous Polyposis (FAP) Has iron deficiency anemia Has history of lower GI bleeding Has metastatic (Stage IV) blood or solid tumor cancer Has end stage renal disease Has cirrhosis Has heart failure Has dementia Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Shivan Mehta, MD
    Organizational Affiliation
    University of Pennsylvania
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Chyke Doubeni, MD
    Organizational Affiliation
    University of Pennsylvania
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Opt-In Versus Opt-Out for Colorectal Cancer Screening Outreach

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