Cancer of the Colon
Conditions
Brief summary
This is a randomized controlled pilot study aimed at testing different outreach strategies (opt-in versus opt-out) to increase colorectal cancer screening through completion of mailed home fecal immunohistochemical testing (FIT).
Detailed description
This is a randomized controlled pilot study aimed at testing different outreach strategies to increase colorectal cancer screening using mailed fecal immunohistochemical testing (FIT). The investigators will randomize a cohort of subjects between the ages of 50-74 into 2 arms: 1. Opt-In - subject must actively choose to receive a home FIT kit. 2. Opt-Out - a FIT kit is sent as a default unless the subject actives chooses not to receive the kit or reports prior screening.
Interventions
BEHAVIORALOpt-In Outreach
Subjects will receive a communication (mail or electronic) describing the importance of colorectal cancer screening with the option to elect to receive a home FIT kit or report prior screening.
BEHAVIORALOpt-Out Outreach
Subjects will receive a communication (mail or electronic) describing the importance of colorectal cancer screening with the option to choose not to receive a home FIT kit or report prior screening. A FIT kit will otherwise be sent to the subject as a default.
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 74 Years
Healthy volunteers
Yes
Inclusion criteria
* Between 50 to 74 years old * Has received care at the Division of Internal Medicine * Due for screening * Asymptomatic for colorectal cancer (CRC)
Exclusion criteria
* Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and fecal occult blood test (FOBT)/FIT within twelve months of the chart review (We will exclude patients who self-report undergoing any of the above procedures) * Has a history of CRC * Has a history of other GI cancer * Has history of confirmed Inflammatory Bowel Disease (IBD) (e.g. Crohn's disease, ulcerative colitis; Irritable bowel syndrome does not exclude patients) * Has history of colitis other than Crohn's disease or ulcerative colitis * Has had a colectomy * Has a relative that has been diagnosed with CRC * Has been diagnosed with Lynch Syndrome (i.e. HNPCC) * Has been diagnosed with Familial Adenomatous Polyposis (FAP) * Has iron deficiency anemia * Has history of lower GI bleeding * Has metastatic (Stage IV) blood or solid tumor cancer * Has end stage renal disease * Has cirrhosis * Has heart failure * Has dementia * Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| FIT Completion Rate | 3 months | The percentage of participants who successfully complete the FIT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mail/Electronic Message Engagement | 3 months | The percentage of people who send responses using either mail or electronic messaging. |
Outcome results
None listed