Colorectal Carcinoma
Conditions
Brief summary
This clinical trial compares audio brochures and video brochures to usual care for increasing colorectal cancer (CRC) screening among adults living in Appalachia. Adults living in rural Appalachia experience increased rates of CRC, possibly due to the unique barriers to screening this population faces, such as lower socioeconomic status, limited health literacy, and less access to healthcare. The fecal immunochemical test (FIT) is a common CRC screening technique which allows individuals to complete the test at home and mail the kit back. A limitation of the current process for FIT screening outreach is that the instruction materials are heavy in text and not appropriate for individuals with limited health literacy. The audio and video brochures used in this clinical trial are instruction materials that have been specially designed to be appropriate for individuals of all health literacy levels. Providing these audio and video brochures with the FIT kits may increase CRC screening among adults living in Appalachia, compared to usual care.
Detailed description
PRIMARY OBJECTIVE: I. Conduct a pilot study of the two developed mail-based FIT outreach interventions versus (vs.) mailed usual care materials to establish acceptability and obtain preliminary efficacy data on increasing CRC screening. OUTLINE: Participants are randomized to 1 of 3 arms. ARM I: Participants receive the FIT kit and usual care on study. ARM II: Participants receive the FIT kit with an audio brochure, disposable gloves and stool collection device, and scheduled reminder on study. ARM III: Participants receive the FIT kit with a video brochure, disposable gloves and stool collection device, and scheduled reminder on study.
Interventions
BEHAVIORALHealth Education
Receive audio brochure
OTHERScheduled Notification
Receive scheduled reminder
OTHERSurvey Administration
Ancillary studies
OTHERBest Practice
Receive usual care
Receive FIT kit
Sponsors
National Institute on Aging (NIA)
Ohio State University Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 64 Years
Healthy volunteers
Yes
Inclusion criteria
* Mid-life men and women (50-64 years old) * Live in Appalachia * Had a medical visit in the past two years * Are at average-risk for CRC (no history of CRC, polyps, inflammatory bowel disease, family history of CRC or hereditary CRC syndromes) * Are not within CRC screening guidelines (no fecal occult blood test/FIT in the past year; flexible sigmoidoscopy in past five years; colonoscopy in past ten years)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants to Return Fecal Immunochemical Test (FIT) | At 2 months | Will estimate FIT return using proportions for each study group. Both comparisons (each intervention compared to control) will be a two-sample test of proportions (intent-to-treat analysis) using a one-sided alpha of 0.1 due to the preliminary nature of the study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm I (FIT, Usual Care) Participants receive the FIT kit and usual care on study.
Best Practice: Receive usual care
Fecal Immunochemical Test: Receive FIT kit
Survey Administration: Ancillary studies | 20 |
| Arm II (FIT, Audio Brochure, Reminder) Participants receive the FIT kit with an audio brochure, disposable gloves and stool collection device, and scheduled reminder on study.
Fecal Immunochemical Test: Receive FIT kit
Health Education: Receive audio brochure
Scheduled Notification: Receive scheduled reminder
Survey Administration: Ancillary studies | 42 |
| Arm III (FIT, Video Brochure, Reminder) Participants receive the FIT kit with a video brochure, disposable gloves and stool collection device, and scheduled reminder on study.
Fecal Immunochemical Test: Receive FIT kit
Health Education: Receive video brochure
Scheduled Notification: Receive scheduled reminder
Survey Administration: Ancillary studies | 32 |
| Total | 94 |
Baseline characteristics
| Characteristic | Arm II (FIT, Audio Brochure, Reminder) | Arm III (FIT, Video Brochure, Reminder) | Total | Arm I (FIT, Usual Care) |
|---|---|---|---|---|
| Age, Continuous | 57.1 years STANDARD_DEVIATION 4.3 | 57.1 years STANDARD_DEVIATION 4.2 | 57.1 years STANDARD_DEVIATION 4.2 | 58.3 years STANDARD_DEVIATION 4.4 |
| Race and Ethnicity Not Collected | — | — | 0 Participants | — |
| Region of Enrollment United States | 42 participants | 32 participants | 94 participants | 20 participants |
| Sex: Female, Male Female | 22 Participants | 15 Participants | 47 Participants | 10 Participants |
| Sex: Female, Male Male | 20 Participants | 17 Participants | 47 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 42 | 0 / 32 |
| other Total, other adverse events | 0 / 20 | 0 / 42 | 0 / 32 |
| serious Total, serious adverse events | 0 / 20 | 0 / 42 | 0 / 32 |
Outcome results
Primary
Number of Participants to Return Fecal Immunochemical Test (FIT)
Will estimate FIT return using proportions for each study group. Both comparisons (each intervention compared to control) will be a two-sample test of proportions (intent-to-treat analysis) using a one-sided alpha of 0.1 due to the preliminary nature of the study.
Time frame: At 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm I (FIT, Usual Care) | Number of Participants to Return Fecal Immunochemical Test (FIT) | 3 Participants |
| Arm II (FIT, Audio Brochure, Reminder) | Number of Participants to Return Fecal Immunochemical Test (FIT) | 4 Participants |
| Arm III (FIT, Video Brochure, Reminder) | Number of Participants to Return Fecal Immunochemical Test (FIT) | 9 Participants |