Clinical trial NCT01568151: Testing Interventions to Motivate and Educate
Official title: Testing Interventions to Motivate and Educate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colorectal Cancer
Keywords: Colorectal Cancer
Screening
Education
Testing
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-04-02
Enrollment: 551
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: This study is being done to see if teaching physicians and people who are at least 50 years old and have not been screened within guidelines for colorectal cancer about the importance of colorectal cancer screening will increase screenings for colorectal cancer. The researchers want to understand what ways will work best to motivate and educate both patients and the doctors and nurses who care for them.

Detailed description: Colorectal cancer (CRC) is the third leading type of cancer and the third leading cause of cancer death in the United States. This study focuses on improving CRC screening in The Ohio State University Primary Care Network (OSUPCN). Ohio has higher than average rates of CRC mortality compared to the rest of the US. The study population for this study will also include minority and older individuals as these groups have higher CRC incidence and mortality rates.

The goal of this study is to test a program to improve CRC screening among male and female patients over the age of 50 in 10 primary care clinics. This study will use physician surveys, focus groups and a community advisory board to finalize the content of the interventions. Five theoretical models form the theoretical framework of the study - the health belief model, social networking, minority health communications model, PEN III, and the transtheoretical model. The interventions will be directed at the clinic and patient levels, and will be tested in a randomized design. Five clinics will receive the clinic plus patient-directed interventions and 5 clinics will be randomized to usual care. The clinic intervention will consist of provider, system and waiting room activities. The individual-directed intervention will include three stepped stages for patients who have not yet been screened: (1) a tailored physician letter, easy-to-read educational materials about CRC and an FOBT information sheet and card; (2) follow-up telephone barriers counseling for patients who do not complete CRC screening after receiving the letter; and (3) in person home visits by lay health advisors (LHA) for those who do not complete CRC screening after receiving the first two interventions. Research staff will conduct a process evaluation of the interventions to identify problems in implementing them and determine the extent to which each of the components is successfully carried out. They will also examine how components of the intervention relate to the theoretical frameworks used to motivate CRC screening completion. If successful, this program can easily be adapted for use by primary care practices and clinics to improve CRC screening.

Eligibility criteria: Inclusion Criteria:

* Age 50 or older
* No prior history of familial/hereditary cancer syndrome (e.g. hereditary non-polyposis colon cancer), polyps, or inflammatory bowel disease (e.g. Crohn's disease)
* Have a current phone number
* Have had 2 or more visits to the Family Practice or General Internal Medicine Clinics in the past 2 years
* Have a current address in records and no definite plans to move within the next year
* Be at average risk for colorectal cancer
* Be in good health as judged by their primary care doctor
* Not be over the age of 85

Exclusion Criteria:

* Less than 50 years old
* Greater than 85 years old
* History of familial/hereditary cancer syndrome, polyps, or Crohn's disease
* History of contraindications to colorectal cancer screening, such as congenital heart failure, renal failure, dementia

Primary outcomes:
measure: Number of participants who undergo colorectal screening because of interventions
timeFrame: Up to 3 and a half years
Secondary outcomes:
measure: Number of problems associated with intervention program
timeFrame: Up to 3 and half years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: The Ohio State University Comprehensive Cancer Center
name: Electra D. Paskett, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Murray DM, Katz ML, Post DM, Pennell ML, Young GS, Tatum CM, Paskett ED. Enhancing cancer screening in primary care: rationale, design, analysis plan, and recruitment results. Contemp Clin Trials. 2013 Mar;34(2):356-63. doi: 10.1016/j.cct.2013.01.003. Epub 2013 Jan 26.