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Assessing Repeat Fit Testing for CRC (ARFT)

Primary Purpose

Colo-rectal Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Now I'm Telling You
Sponsored by
Richard Crosby
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Colo-rectal Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • must have completed and returned an initial FIT kit to us as part of a Rural Cancer Prevention Center service program to the community

Exclusion Criteria:

  • visible blood in stool or prior diagnosis of cool-rectal cancer

Sites / Locations

  • University of Kentucky

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention media condition

control condition

Arm Description

monthly social media contact will be used to keep people connected to the idea of completing a second screening test 12 months after their last one.

this group will receive only a standard reminder for the annual repeat test, one month before the test due date

Outcomes

Primary Outcome Measures

Primary endpoint is a received completed FIT kit within 15 months after the participant received results from the original FIT test
the endpoint is a received completed FIT kit

Secondary Outcome Measures

Full Information

First Posted
July 24, 2015
Last Updated
February 19, 2019
Sponsor
Richard Crosby
Collaborators
Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT03248661
Brief Title
Assessing Repeat Fit Testing for CRC
Acronym
ARFT
Official Title
Assessing Repeat Annual FIT Screening for Colo-Rectal Cancer (CRC)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2015 (Actual)
Primary Completion Date
September 25, 2018 (Actual)
Study Completion Date
September 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Richard Crosby
Collaborators
Centers for Disease Control and Prevention

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will randomly assign 220 men and women to either a social media intervention or a standard reminder system to have a repeat screening test for colo-rectal cancer.
Detailed Description
Only persons initially screening by FIT (through a Rural Cancer Prevention Center service program) will be eligible for study participation. The objective is to test a social media-based intervention designed to promote annual repeat colo-rectal cancer screening using the Fecal Immunochemical Test (FIT) among person who have taken the FIT test once before. 220 men and women (50 to 75 years of age) will be recruited and randomly assigned to either the intervention condition (monthly social media contact) or a control condition (standard of care reminder for repeat testing one month before the annual test is due). The dependent variable will be whether volunteers requested and retuned a FIT kit with 60 days of the annual due date (one year from their initial screening).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colo-rectal Cancer

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention media condition
Arm Type
Experimental
Arm Description
monthly social media contact will be used to keep people connected to the idea of completing a second screening test 12 months after their last one.
Arm Title
control condition
Arm Type
No Intervention
Arm Description
this group will receive only a standard reminder for the annual repeat test, one month before the test due date
Intervention Type
Behavioral
Intervention Name(s)
Now I'm Telling You
Intervention Description
Messages will be sent trough Facebook, Twitter, Instagram, e-mail, texting or other electronic/social media specified by study volunteers.
Primary Outcome Measure Information:
Title
Primary endpoint is a received completed FIT kit within 15 months after the participant received results from the original FIT test
Description
the endpoint is a received completed FIT kit
Time Frame
15 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: must have completed and returned an initial FIT kit to us as part of a Rural Cancer Prevention Center service program to the community Exclusion Criteria: visible blood in stool or prior diagnosis of cool-rectal cancer
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States

12. IPD Sharing Statement

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Assessing Repeat Fit Testing for CRC

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