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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Kimberly Engelman, PhD, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier:
NCT00599378
First received: December 31, 2007
Last updated: September 6, 2013
Last verified: September 2013
  Purpose

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


Condition Intervention
Colorectal Cancer
Behavioral: Implementation Intentions-based telephone counseling

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Implementation Intentions to Promote Colon Cancer Screening in Rural Primary Care Practice

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 120 day followup survey to assess perceived barriers and screening decisional stage [ Time Frame: 120 Days ] [ Designated as safety issue: No ]

Enrollment: 373
Study Start Date: September 2007
Study Completion Date: June 2012
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
Implementation Intentions-based telephone counseling
No Intervention: 2
Healthy Living information on Physical Activity and Nutrition

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00599378

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Kimberly Engelman, PhD
Investigators
Principal Investigator: Kimberly K. Engelman, PhD University of Kansas
  More Information

No publications provided

Responsible Party: Kimberly Engelman, PhD, Associate Professor, University of Kansas Medical Center Research Institute
ClinicalTrials.gov Identifier: NCT00599378     History of Changes
Other Study ID Numbers: 11018, 1R01CA121016-01A2
Study First Received: December 31, 2007
Last Updated: September 6, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 14, 2014