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Colorectal Cancer Screening in a Community Health Setting

Primary Purpose

Cancer of the Colon

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text-only
Text + Lottery
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 focused on measuring Colorectal Neoplasms, Colonic Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases, Rectal Diseases

Eligibility Criteria

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

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

Sites / Locations

  • Family Practice & Counseling Network - Health Annex

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Text-only

Text + Lottery

Arm Description

Text-only outreach

Text outreach + financial incentive

Outcomes

Primary Outcome Measures

FIT completion within 3 months
The percentage of participants who successfully complete the FIT

Secondary Outcome Measures

Response to text-based CRC screening outreach
The percentage of people who respond to text message

Full Information

First Posted
February 23, 2017
Last Updated
February 19, 2019
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT03072095
Brief Title
Colorectal Cancer Screening in a Community Health Setting
Official Title
Patient-Centered Outreach to Increase Colorectal Cancer Screening in a Community Health Setting
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
April 17, 2017 (Actual)
Primary Completion Date
August 3, 2017 (Actual)
Study Completion Date
November 3, 2017 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: text messaging outreach (text) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of the Colon
Keywords
Colorectal Neoplasms, Colonic Neoplasms, Gastrointestinal Neoplasms, Digestive System Neoplasms, Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases, Rectal Diseases

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Text-only
Arm Type
Experimental
Arm Description
Text-only outreach
Arm Title
Text + Lottery
Arm Type
Experimental
Arm Description
Text outreach + financial incentive
Intervention Type
Behavioral
Intervention Name(s)
Text-only
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Text + Lottery
Intervention Description
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 Measure Information:
Title
FIT completion within 3 months
Description
The percentage of participants who successfully complete the FIT
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Response to text-based CRC screening outreach
Description
The percentage of people who respond to text message
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 and 74 years old Has active medical insurance Has had had at least one visit at Health Annex in the prior 12 months (at time of chart review) Due for CRC screening (no colonoscopy in last 10 years, sigmoidoscopy in last 5 years, or stool testing in last 1 year) Asymptomatic for CRC Exclusion Criteria: 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) Has a history of CRC Has a history of other GI cancer Has history of confirmed Inflammatory Bowel Disease (IBD) (e.g. Crohns disease, ulcerative colitis) Has a history of colon polyps Has had a colectomy Has a first-degree 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 recent 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 liver cirrhosis Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study Does not use a mobile phone enabled to send and receive text messages
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shivan Mehta, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
Family Practice & Counseling Network - Health Annex
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19142
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32477853
Citation
Mehta SJ, Oyalowo A, Reitz C, Dean O, McAuliffe T, Asch DA, Doubeni CA. Text messaging and lottery incentive to improve colorectal cancer screening outreach at a community health center: A randomized controlled trial. Prev Med Rep. 2020 May 8;19:101114. doi: 10.1016/j.pmedr.2020.101114. eCollection 2020 Sep.
Results Reference
derived

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Colorectal Cancer Screening in a Community Health Setting

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