NCT03248661

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P25-P50 for phase_3 colorectal-cancer

Timeline
Completed

Started Aug 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2015

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
2 years until next milestone

First Posted

Study publicly available on registry

August 14, 2017

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2018

Completed
Last Updated

February 21, 2019

Status Verified

January 1, 2019

Enrollment Period

3.2 years

First QC Date

July 24, 2015

Last Update Submit

February 19, 2019

Conditions

Colo-rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

    15 months

Study Arms (2)

Intervention media condition

EXPERIMENTAL

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

control condition

NO INTERVENTION

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

Interventions

Now I'm Telling YouBEHAVIORAL

Messages will be sent trough Facebook, Twitter, Instagram, e-mail, texting or other electronic/social media specified by study volunteers.

Intervention media condition

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

July 24, 2015

First Posted

August 14, 2017

Study Start

August 1, 2015

Primary Completion

September 25, 2018

Study Completion

September 25, 2018

Last Updated

February 21, 2019

Record last verified: 2019-01

Locations

US(1)