NCT03100461

Brief Summary

The goal of this study is to find the best ways to increase colorectal cancer (CRC) screening.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable colorectal-cancer

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

March 29, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 4, 2017

Completed
10 months until next milestone

Study Start

First participant enrolled

January 22, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

October 15, 2024

Status Verified

May 1, 2020

Enrollment Period

4.6 years

First QC Date

March 29, 2017

Last Update Submit

October 8, 2024

Conditions

Keywords

Cancer ScreeningColon CancerColon Cancer Screening

Outcome Measures

Primary Outcomes (1)

  • CRC screening completion rate

    Rate of participants who receive CRC screening during study participation

    12-14 Months

Secondary Outcomes (1)

  • Cost analysis of each intervention pathway

    14 Months

Study Arms (4)

HE + HE

ACTIVE COMPARATOR

Participants receive up to two interventions. Participants receive HE initially and then a second time if not screened after 6 months.

Other: Health Education

HE + I2

ACTIVE COMPARATOR

Participants receive up to two interventions. Participants receive HE initially and then I2 if not screened after 6 months.

Other: I2Other: Health Education

I2 + I2

EXPERIMENTAL

Participants receive up to two interventions. Participants receive I2 initially and then a second time if not screened after 6 months.

Other: I2

I2 + HE

ACTIVE COMPARATOR

Participants receive up to two interventions. Participants receive I2 initially and then HE if not screened after 6 months.

Other: I2Other: Health Education

Interventions

I2OTHER

A touch screen computer delivered "implementation intentions" (I2) intervention on CRC screening. "Implementation intentions" are the exact steps (the when, what, where, how) one will take to complete a test (the date and time, at home or at the doctor's office, with what supplies, etc.).

Also known as: Implementation Intentions
HE + I2I2 + HEI2 + I2

Standard of care approach that will provide basic information on CRC screening.

HE + HEHE + I2I2 + HE

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have a home address and access to a working telephone
  • Pass Mini-Cog assessment

You may not qualify if:

  • FIT (fecal immunochemical test) test within 1 year, Sigmoidoscopy or Barium enema within 5 years, or Colonoscopy within 10 years
  • Acute medical illness,
  • current GI bleed
  • history of adenomatous polyps
  • Colorectal Cancer
  • st degree relative with CRC \< age 60 years
  • inherited polyposis/non-polyposis syndrome
  • inflammatory bowel disease
  • Another household member enrolled in the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsColonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Allen Greiner, MD, MPH

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2017

First Posted

April 4, 2017

Study Start

January 22, 2018

Primary Completion

August 31, 2022

Study Completion

September 30, 2022

Last Updated

October 15, 2024

Record last verified: 2020-05

Locations