Clinical trial NCT00599378: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-01-23
Enrollment: 373
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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 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

Primary outcomes:
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
timeFrame: 60 days
Secondary outcomes:
measure: 120 day followup survey to assess perceived barriers and screening decisional stage
timeFrame: 120 Days
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
Study officials:
affiliation: University of Kansas Medical Center
name: Kimberly K. Engelman, PhD
role: PRINCIPAL_INVESTIGATOR
References: