Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Assessing Repeat Fit Testing for CRC (ARFT)

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: NCT03248661
Recruitment Status : Completed
First Posted : August 14, 2017
Last Update Posted : February 21, 2019
Sponsor:
Collaborator:
Centers for Disease Control and Prevention
Information provided by (Responsible Party):
Richard Crosby, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Colo-rectal Cancer Behavioral: Now I'm Telling You Phase 3

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).

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Assessing Repeat Annual FIT Screening for Colo-Rectal Cancer (CRC)
Actual Study Start Date : August 1, 2015
Actual Primary Completion Date : September 25, 2018
Actual Study Completion Date : September 25, 2018

Arm Intervention/treatment
Experimental: Intervention media condition
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.
Behavioral: Now I'm Telling You
Messages will be sent trough Facebook, Twitter, Instagram, e-mail, texting or other electronic/social media specified by study volunteers.

No Intervention: control condition
this group will receive only a standard reminder for the annual repeat test, one month before the test due date



Primary Outcome Measures :
  1. Primary endpoint is a received completed FIT kit within 15 months after the participant received results from the original FIT test [ Time Frame: 15 months ]
    the endpoint is a received completed FIT kit



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   30 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT03248661


Locations
Layout table for location information
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40506
Sponsors and Collaborators
Richard Crosby
Centers for Disease Control and Prevention
Layout table for additonal information
Responsible Party: Richard Crosby, PI, University of Kentucky
ClinicalTrials.gov Identifier: NCT03248661    
Other Study ID Numbers: 14-0662-P3H
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: February 21, 2019
Last Verified: January 2019
Additional relevant MeSH terms:
Layout table for MeSH terms
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases