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Single Center Randomized Pilot Study Of Colorectal Cancer Screening Outreach (CRCSO)

Primary Purpose

Colorectal Cancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Financial Incentive
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colorectal Cancer

Eligibility Criteria

50 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Between 50 to 75 years old
  • Has had at least two visits at Penn Family Care Within the past two years - Due for screening
  • Asymptomatic for colorectal cancer (CRC)
  • Zip code listed in PennChart as part of the subjects address is within the Philadelphia-Wilmington-Camden Metropolitan Statistical Area
  • Have a primary care provider in Penn Family Care

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 anemia (iron-deficient or general/unspecified)
  • Has history of lower GI bleeding
  • Has metastatic (Stage IV) blood or solid tumor cancer
  • Has end stage renal disease
  • Has had congestive heart failure
  • Has dementia
  • Has cirrhosis or end stage liver disease
  • 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 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Arm Label

    usual care

    unconditional fixed incentive

    conditional fixed incentive

    conditional lottery incentive

    Arm Description

    Each FIT kit will include a tube in which to deposit the stool sample, directions on how to collect and mail the sample, a letter about colorectal cancer screening, a Labcorp requisition form, and a pre-paid return envelope.

    This arm will receive a FIT kit as described in the mailed FIT arm and will also receive a financial incentive in the form of a gift card and a note explaining that this gift card is a token of our appreciation for completing the kit.

    This arm will receive a FIT kit as described in the mailed FIT arm and will receive a note stating that they will receive a financial incentive in the form of a gift card if they return their completed FIT within two months of receiving the FIT kit.

    This arm will receive a FIT kit as described in the mailed FIT arm and will receive a note stating that they will be entered in a 1/10 chance lottery to receive a financial incentive in the form of a gift card if they return their completed FIT within two months of receiving the FIT kit.

    Outcomes

    Primary Outcome Measures

    Increase in return rate of completed FIT
    An increase in return rate of completed FIT between intervention arms when compared to the control arm

    Secondary Outcome Measures

    Full Information

    First Posted
    October 29, 2015
    Last Updated
    February 19, 2019
    Sponsor
    University of Pennsylvania
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02594150
    Brief Title
    Single Center Randomized Pilot Study Of Colorectal Cancer Screening Outreach
    Acronym
    CRCSO
    Official Title
    Single Center Randomized Pilot Study Of Colorectal Cancer Screening Outreach
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2015 (Actual)
    Primary Completion Date
    March 2018 (Actual)
    Study Completion Date
    September 2018 (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
    A four arm randomized pilot study to assess if the rate of completion of Fecal Immunochemical Test is increased by the addition of financial incentives.
    Detailed Description
    This is a single center 4-arm randomized pilot study to assess if the rate of completion of Fecal Immunochemical Test (FIT) is increased by the addition of financial incentives. Potentially eligible subjects will be identified via a data abstraction by Penn Data Store. We will conduct Electronic Medical Record (EMR) reviews on randomly select patients from the data abstraction using PennChart to confirm eligibility until 1,080 patients are identified. We will then randomize these 1,080 patients to one of four arms during the intervention phase. Arm 1: mailed FIT kit (usual care) Arm 2: mailed FIT kit + a gift card included in mailing (unconditional fixed incentive) Arm 3: mailed FIT kit + guarantee of receiving a gift card if kit is returned within two months (conditional fixed incentive) Arm 4: mailed FIT kit + entry in a 1/10 chance lottery to receive a gift card if kit is returned within two months (conditional lottery incentive) All 1,080 subjects will receive the mailed FIT kit. Subjects whose FIT results are not recorded in PennChart will receive a follow-up phone call via Interactive Voice Response (IVR) three weeks after the kit was mailed to the subject. Subjects whose FIT results are not recorded in PennChart will receive a follow-up mailed reminder six weeks after the kit was mailed to the subject. Subjects will receive follow-up regardless of the arm to which they are randomized. A random sub-sample of 200 subjects will be called at least twelve weeks after the kit was mailed to the subject to complete a questionnaire. Verbal consent will be obtained from this sub-sample. This phone call will occur after the intervention and follow-up phases are completed. Analysis will occur after the sub-sample questionnaire phase is completed.

    6. Conditions and Keywords

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

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    usual care
    Arm Type
    No Intervention
    Arm Description
    Each FIT kit will include a tube in which to deposit the stool sample, directions on how to collect and mail the sample, a letter about colorectal cancer screening, a Labcorp requisition form, and a pre-paid return envelope.
    Arm Title
    unconditional fixed incentive
    Arm Type
    Experimental
    Arm Description
    This arm will receive a FIT kit as described in the mailed FIT arm and will also receive a financial incentive in the form of a gift card and a note explaining that this gift card is a token of our appreciation for completing the kit.
    Arm Title
    conditional fixed incentive
    Arm Type
    Experimental
    Arm Description
    This arm will receive a FIT kit as described in the mailed FIT arm and will receive a note stating that they will receive a financial incentive in the form of a gift card if they return their completed FIT within two months of receiving the FIT kit.
    Arm Title
    conditional lottery incentive
    Arm Type
    Experimental
    Arm Description
    This arm will receive a FIT kit as described in the mailed FIT arm and will receive a note stating that they will be entered in a 1/10 chance lottery to receive a financial incentive in the form of a gift card if they return their completed FIT within two months of receiving the FIT kit.
    Intervention Type
    Other
    Intervention Name(s)
    Financial Incentive
    Intervention Description
    Financial incentives provide small immediate and tangible rewards that are aligned with the abstract long-term rewards of cancer prevention.
    Primary Outcome Measure Information:
    Title
    Increase in return rate of completed FIT
    Description
    An increase in return rate of completed FIT between intervention arms when compared to the control arm
    Time Frame
    2 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Between 50 to 75 years old Has had at least two visits at Penn Family Care Within the past two years - Due for screening Asymptomatic for colorectal cancer (CRC) Zip code listed in PennChart as part of the subjects address is within the Philadelphia-Wilmington-Camden Metropolitan Statistical Area Have a primary care provider in Penn Family Care 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 anemia (iron-deficient or general/unspecified) Has history of lower GI bleeding Has metastatic (Stage IV) blood or solid tumor cancer Has end stage renal disease Has had congestive heart failure Has dementia Has cirrhosis or end stage liver disease 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 MBA MSHP
    Organizational Affiliation
    University of Pennsylvania
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Chyke Doubeni, MD MPH
    Organizational Affiliation
    University of Pennsylvania
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30901053
    Citation
    Mehta SJ, Pepe RS, Gabler NB, Kanneganti M, Reitz C, Saia C, Teel J, Asch DA, Volpp KG, Doubeni CA. Effect of Financial Incentives on Patient Use of Mailed Colorectal Cancer Screening Tests: A Randomized Clinical Trial. JAMA Netw Open. 2019 Mar 1;2(3):e191156. doi: 10.1001/jamanetworkopen.2019.1156. Erratum In: JAMA Netw Open. 2019 Apr 5;2(4):e193771.
    Results Reference
    derived

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    Single Center Randomized Pilot Study Of Colorectal Cancer Screening Outreach

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