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Trial record 21 of 3616 for:    colon cancer AND Colonic Diseases

Colorectal Cancer Screening in a Community Health Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03072095
Recruitment Status : Completed
First Posted : March 7, 2017
Last Update Posted : February 20, 2019
Sponsor:
Information provided by (Responsible Party):
Shivan J Mehta, University of Pennsylvania

Brief Summary:
This randomized controlled pilot study at the Health Annex, Family Practice & Counseling Network (FPCN), a community clinic in Southwest Philadelphia, aimed at providing data on the feasibility of a mailed FIT approach to CRC screening in a community health setting, and how patients respond to text messaging and behavioral economic engagement incentives.

Condition or disease Intervention/treatment Phase
Cancer of the Colon Behavioral: Text-only Behavioral: Text + Lottery Not Applicable

Detailed Description:

This is a single-center RCT at the Family Practice & Counseling Network (FPCN), a community clinic in Southwest Philadelphia with 320 eligible subjects between the ages of 50-74 randomized to two study arms:

  1. text messaging outreach (text)
  2. text messaging outreach with lottery for 1/5 chance to win a financial incentive (text + lottery).

Findings will provide data on the feasibility of this mailed FIT approach in a community health setting, and how patients respond to text messaging and behavioral economic engagement incentives.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 281 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Screening
Official Title: Patient-Centered Outreach to Increase Colorectal Cancer Screening in a Community Health Setting
Actual Study Start Date : April 17, 2017
Actual Primary Completion Date : August 3, 2017
Actual Study Completion Date : November 3, 2017

Arm Intervention/treatment
Experimental: Text-only
Text-only outreach
Behavioral: Text-only
Subjects will receive a text communication indicating they are overdue for colon cancer screening with the option to elect to receive a free, at-home FIT kit.

Experimental: Text + Lottery
Text outreach + financial incentive
Behavioral: Text + Lottery
Subjects will receive a text communication indicating they are overdue for colon cancer screening with the option to elect to receive a free, at-home FIT kit and a 1 in 5 chance to win a $100 gift card for completing the kit.




Primary Outcome Measures :
  1. FIT completion within 3 months [ Time Frame: 3 months ]
    The percentage of participants who successfully complete the FIT


Secondary Outcome Measures :
  1. Response to text-based CRC screening outreach [ Time Frame: 3 months ]
    The percentage of people who respond to text message



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Between 50 and 74 years old
  2. Has active medical insurance
  3. Has had had at least one visit at Health Annex in the prior 12 months (at time of chart review)
  4. Due for CRC screening (no colonoscopy in last 10 years, sigmoidoscopy in last 5 years, or stool testing in last 1 year)
  5. Asymptomatic for CRC

Exclusion Criteria:

  1. Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and FOBT/FIT within twelve months of the chart review (we will exclude patients who self-report undergoing any of the above procedures)
  2. Has a history of CRC
  3. Has a history of other GI cancer
  4. Has history of confirmed Inflammatory Bowel Disease (IBD) (e.g. Crohns disease, ulcerative colitis)
  5. Has a history of colon polyps
  6. Has had a colectomy
  7. Has a first-degree relative that has been diagnosed with CRC
  8. Has been diagnosed with Lynch Syndrome (i.e. HNPCC)
  9. Has been diagnosed with Familial Adenomatous Polyposis (FAP).
  10. Has iron deficiency anemia
  11. Has recent history of lower GI bleeding
  12. Has metastatic (Stage IV) blood or solid tumor cancer
  13. Has end stage renal disease
  14. Has had congestive heart failure
  15. Has dementia
  16. Has liver cirrhosis
  17. Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study
  18. Does not use a mobile phone enabled to send and receive text messages

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): NCT03072095


Locations
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United States, Pennsylvania
Family Practice & Counseling Network - Health Annex
Philadelphia, Pennsylvania, United States, 19142
Sponsors and Collaborators
University of Pennsylvania
Investigators
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Principal Investigator: Shivan Mehta, MD University of Pennsylvania

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Responsible Party: Shivan J Mehta, Principal Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier: NCT03072095     History of Changes
Other Study ID Numbers: 826576
First Posted: March 7, 2017    Key Record Dates
Last Update Posted: February 20, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shivan J Mehta, University of Pennsylvania:
Colorectal Neoplasms
Colonic Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Rectal Diseases
Additional relevant MeSH terms:
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Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases