Expired Study
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Kansas City, Kansas 66160


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

Study summary:

Although colorectal cancer (CRC) is preventable and curable if detected early, a large portion of the population is not current with screening recommendations. Many unscreened individuals 50 years of age and older do not receive health care system prompts to promote adherence to test preparation or completion. This study will assess the efficacy of a novel prompting intervention based on the concept of "implementation intentions". The intervention will be delivered through a partnership between patients, rural primary care physicians, and trained CRC information specialists (CRC-IS) and will focus on the 'recalcitrant' primary care population. A randomized design will test a comparison condition of a "no-partnership" system with generic information versus a "partnership" intervention system that specifically addresses each participants' CRC screening "implementation intentions" (the "when," "where" and "how" screening details). The study will be conducted with 600 patients eligible for CRC screening and recruited while presenting for care in a set of Research Network affiliated primary care clinics, or patient contact information gathered from in-house chart reviews. All participants who are not up-to-date on CRC screening, or not at high risk for CRC, will receive a baseline tablet PC-administered CRC assessment, or a letter of invitation from their PC physician to go online to the Healthy Living Kansas patient portal to complete the assessment. Completion of CRC screening at 60 days post index visit will be assessed through follow-up phone calls. Those not completing CRC screening after taking the assessment,(i.e., recalcitrant participants) then will be randomized to either C (comparison group-"no-partnership") or CPI2 (active intervention-CRC-IS/ physician/patient partnership and implementation intentions-based communication concepts). Physicians will receive informational fax sheets summarizing all participant phone calls. A 120-day post randomization follow-up telephone call will assess the effects of implementation intentions communications and perceived CRC screening barriers encountered. The primary outcome will be CRC screening adherence at 120 days. Secondary outcomes will assess 120-day perceived barriers and advancement in screening decisional stage. This intervention will provide information on the utility of embedding an "implementation intentions" based behavioral intervention for promoting CRC screening among initially non-adherent primary care patients.


Inclusion Criteria: - 50 years of age or older - at average risk for colorectal cancer - not up to date with colorectal cancer screening Exclusion Criteria: - Younger than 50 years of age - at high risk for colorectal cancer - up to date with colorectal cancer screening

Study is Available At:

Original ID:




Secondary ID:


Study Acronym:

Brief Title:

Implementation Intentions to Promote Colon Cancer Screening in Rural Primary Care Practice

Official Title:

Implementation Intentions to Promote Colon Cancer Screening in Rural Primary Care Practice

Overall Status:


Study Phase:




Minimum Age:

50 Years

Maximum Age:


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Kansas

Oversight Authority:

United States: Institutional Review Board

Reasons Why Stopped:

Study Type:


Study Design:

Allocation: Randomized, Endpoint Classification:

Number of Arms:


Number of Groups:


Total Enrollment:


Enrollment Type:


Overall Contact Information

Official Name:Kimberly K. Engelman, PhD
Principal Investigator
University of Kansas

Study Dates

Start Date:September 2007
Completion Date:June 2012
Completion Type:Actual
Primary Completion Date:December 2011
Primary Completion Type:Actual
Verification Date:September 2013
Last Changed Date:September 6, 2013
First Received Date:December 31, 2007

Study Outcomes

Outcome Type:Secondary Outcome
Measure:120 day followup survey to assess perceived barriers and screening decisional stage
Time Frame:120 Days
Safety Issues:False
Outcome Type:Primary Outcome
Measure: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
Time Frame:60 days
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Implementation Intentions-based telephone counseli
Description:Implementation Intentions-based telephone counseling
Arm Name:1

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:Implementation Intentions-based telephone counseling. Partnership intervention between rural Primary Care Physicians, their patients, and CRC Information Specialists using an implementation intentions based approach.
Study Arm Type:No Intervention
Arm Name:2
Description:Healthy Living information on Physical Activity and Nutrition

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Kimberly Engelman, PhD
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Cancer Institute (NCI)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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