Cancer of Colon
Conditions
Brief summary
This pilot study is a 3-arm randomized control trial assessing the effectiveness of sequential or active choice in CRC (colorectal cancer) screening outreach vs. colonoscopy outreach only, in patients between 50-74 years old, who have received care at the University City or Valley Forge CCA (Community Care Associates) practices, are due for screening, and are asymptomatic for CRC. The three arms are: Arm 1: Direct schedule colonoscopy (Control), Arm 2: Direct schedule colonoscopy followed by mailed FIT(Fecal Immunochemical Test) (Sequential Choice), and Arm 3: Choice of direct schedule colonoscopy or mailed FIT (Active Choice).
Detailed description
This pilot study is a 3-arm randomized control trial assessing the effectiveness of sequential or active choice in CRC screening outreach vs. colonoscopy outreach only. The investigators will randomize participants to one of three study arms: Arm 1: Direct schedule colonoscopy (Control) Arm 2: Direct schedule colonoscopy followed by mailed FIT (Sequential Choice) Arm 3: Choice of direct schedule colonoscopy or mailed FIT (Active Choice).
Interventions
BEHAVIORALColonoscopy only
Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line. Subjects not scheduled after 4 weeks will receive a reminder letter to schedule colonoscopy.
BEHAVIORALColonoscopy outreach + mailed FIT follow-up
Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line. Subjects not scheduled after 4 weeks will receive a reminder letter to either schedule colonoscopy or to complete the enclosed mailed FIT kit.
BEHAVIORALColonoscopy + Mailed FIT outreach and follow-up
Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line OR complete the enclosed mailed FIT kit. Subjects who have not completed FIT or scheduled colonoscopy within 4 weeks will be receive a reminder letter to either schedule colonoscopy or complete the mailed FIT kit previously sent.
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 and 74 years old * Has a primary care provider who is a University City or Valley Forge Family Medicine provider * Has had at least 2 office visits at either practice * Is due for colorectal cancer screening * Is asymptomatic for CRC * Subject's zip code is within the Philadelphia-Wilmington-Camden Metropolitan Statistical Area
Exclusion criteria
* Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, or FOBT/FIT within twelve months of chart review (we will exclude patients who self-report any of the above procedures) * Has a history of CRC or colonic polyps * Has a history of GI cancer * Has a history of confirmed Inflammatory Bowel Disease (IBD) * has a history of colitis other than Crohns disease or ulcerative colitis) * Has a first degree relative that has been diagnosed with CRC * Has had a colectomy * Has been diagnosed with Familial Adenomatous Polyposis (FAP) * Has been diagnosed with Lynch Syndrome (i.e. HNPCC) * Has iron-deficiency anemia * Has a 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 |
|---|---|---|
| CRC screening completion | 4 months | The percentage of participants who successfully complete FIT or colonoscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Choice of screening test | 4 months | The percentage of participants who choose either screening method (FIT vs. colonoscopy) |
Countries
United States
Outcome results
None listed