NCT00599378

Brief Summary

To assess the efficacy of a novel prompting intervention based on the concept of "implementation intentions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
373

participants targeted

Target at P50-P75 for not_applicable colorectal-cancer

Timeline
Completed

Started Sep 2007

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

Study Start

First participant enrolled

September 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2007

Completed
23 days until next milestone

First Posted

Study publicly available on registry

January 23, 2008

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
Last Updated

September 10, 2013

Status Verified

September 1, 2013

Enrollment Period

4.3 years

First QC Date

December 31, 2007

Last Update Submit

September 6, 2013

Conditions

Colorectal Cancer

Outcome Measures

Primary Outcomes (1)

  • Follow up survey to assess participant compliance with CRC screening. For those non compliant participants, randomized to either Control group or CPI2 group - active intervention with implementation intentions-based communication concepts

    60 days

Secondary Outcomes (1)

  • 120 day followup survey to assess perceived barriers and screening decisional stage

    120 Days

Study Arms (2)

1

EXPERIMENTAL

Implementation Intentions-based telephone counseling. Partnership intervention between rural Primary Care Physicians, their patients, and CRC Information Specialists using an implementation intentions based approach.

Behavioral: Implementation Intentions-based telephone counseling

2

NO INTERVENTION

Healthy Living information on Physical Activity and Nutrition

Interventions

Implementation Intentions-based telephone counselingBEHAVIORAL

Implementation Intentions-based telephone counseling

1

Eligibility Criteria

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

You may qualify if:

  • years of age or older
  • at average risk for colorectal cancer
  • not up to date with colorectal cancer screening

You may not qualify if:

  • Younger than 50 years of age
  • at high risk for colorectal cancer
  • up to date with colorectal cancer screening

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 Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

  • Kimberly K. Engelman, PhD

    University of Kansas Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 31, 2007

First Posted

January 23, 2008

Study Start

September 1, 2007

Primary Completion

December 1, 2011

Study Completion

June 1, 2012

Last Updated

September 10, 2013

Record last verified: 2013-09

Locations

US(1)