Testing Interventions to Motivate and Educate
50 Years
85 Years
Both
Colorectal Cancer
Trial Information
Testing Interventions to Motivate and Educate
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening
Outcome Measure:
Number of participants who undergo colorectal screening because of interventions
Outcome Description:
The effectiveness of clinic-directed interventions in encouraging subjects to undergo colorectal cancer screening in the 5 intervention clinics in the first 12 months will be assessed. The subjects who did not undergo colorectal cancer screening during that year will then undergo patient-directed intervention for up to a year. The effectiveness of both of these types of intervention will be compared to the control clinics where there is no intervention.
Outcome Time Frame:
Up to 3 and a half years
Safety Issue:
No
Principal Investigator
Electra D. Paskett, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Ohio State University Comprehensive Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
TIME
NCT ID:
NCT01568151
Start Date:
July 2008
Completion Date:
December 2012
Related Keywords:
- Colorectal Cancer
- Colorectal Cancer
- Screening
- Education
- Testing
- Colorectal Neoplasms
Name | Location |
|---|---|
| The Ohio State University Comprehensive Cancer Center | Columbus, Ohio 43210 |
