Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 21 of 3611 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

Tracking Information
First Submitted Date  ICMJE February 23, 2017
First Posted Date  ICMJE March 7, 2017
Last Update Posted Date February 20, 2019
Actual Study Start Date  ICMJE April 17, 2017
Actual Primary Completion Date August 3, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
FIT completion within 3 months [ Time Frame: 3 months ]
The percentage of participants who successfully complete the FIT
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03072095 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 1, 2017)
Response to text-based CRC screening outreach [ Time Frame: 3 months ]
The percentage of people who respond to text message
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Colorectal Cancer Screening in a Community Health Setting
Official Title  ICMJE Patient-Centered Outreach to Increase Colorectal Cancer Screening in a Community Health Setting
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Screening
Condition  ICMJE Cancer of the Colon
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Text-only
    Text-only outreach
    Intervention: Behavioral: Text-only
  • Experimental: Text + Lottery
    Text outreach + financial incentive
    Intervention: Behavioral: Text + Lottery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 19, 2019)
281
Original Estimated Enrollment  ICMJE
 (submitted: March 1, 2017)
320
Actual Study Completion Date  ICMJE November 3, 2017
Actual Primary Completion Date August 3, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03072095
Other Study ID Numbers  ICMJE 826576
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Shivan J Mehta, University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Shivan Mehta, MD University of Pennsylvania
PRS Account University of Pennsylvania
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP