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

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ClinicalTrials.gov Identifier: NCT02594150
Recruitment Status : Completed
First Posted : November 2, 2015
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania

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.

Condition or disease Intervention/treatment Phase
Colorectal Cancer Other: Financial Incentive Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 897 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Screening
Official Title: Single Center Randomized Pilot Study Of Colorectal Cancer Screening Outreach
Actual Study Start Date : December 2015
Actual Primary Completion Date : March 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: usual care
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.
Experimental: unconditional fixed incentive
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.
Other: Financial Incentive
Financial incentives provide small immediate and tangible rewards that are aligned with the abstract long-term rewards of cancer prevention.

Experimental: conditional fixed incentive
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.
Other: Financial Incentive
Financial incentives provide small immediate and tangible rewards that are aligned with the abstract long-term rewards of cancer prevention.

Experimental: conditional lottery incentive
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.
Other: Financial Incentive
Financial incentives provide small immediate and tangible rewards that are aligned with the abstract long-term rewards of cancer prevention.




Primary Outcome Measures :
  1. Increase in return rate of completed FIT [ Time Frame: 2 months ]
    An increase in return rate of completed FIT between intervention arms when compared to the control arm



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Ages Eligible for Study:   50 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594150


Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Shivan Mehta, MD MBA MSHP University of Pennsylvania
Principal Investigator: Chyke Doubeni, MD MPH University of Pennsylvania

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT02594150     History of Changes
Other Study ID Numbers: 823388
First Posted: November 2, 2015    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases