Colorectal CarcinomaNCT05810714
Audio and Video Brochures for Increasing Colorectal Cancer Screening Among Adults Living in Appalachia
A study testing Best Practice, Fecal Immunochemical Test and Health Education in people with Colorectal Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- Best Practice, Fecal Immunochemical Test and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Nov 2021to 1 Feb 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: Increasing CRC Screening Using Audio and Video Brochures: A Pilot Randomized Controlled Trial
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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.
- Conditions
- Colorectal Carcinoma
- Being tested
- Best Practice, Fecal Immunochemical Test, Health Education, Scheduled Notification, Survey Administration
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Best PracticeOther
Also called standard of care, standard therapy
Receive usual care
Fecal Immunochemical TestOther
Also called FIT, iFOBT, immunoassay fecal occult blood test, immunochemical fecal occult blood test
Receive FIT kit
Health EducationBehavioural
Receive audio brochure
Health EducationBehavioural
Receive video brochure
Scheduled NotificationOther
Also called ScheduledNotification
Receive scheduled reminder
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (FIT, usual care) | Active comparator | Participants receive the FIT kit and usual care on study. Receives: Other: Best Practice; Other: Fecal Immunochemical Test; Other: Survey Administration |
| Arm II (FIT, audio brochure, reminder) | Experimental | Participants receive the FIT kit with an audio brochure, disposable gloves and stool collection device, and scheduled reminder on study. Receives: Other: Fecal Immunochemical Test; Behavioral: Health Education; Other: Scheduled Notification; Other: Survey Administration |
| Arm III (FIT, video brochure, reminder) | Experimental | Participants receive the FIT kit with a video brochure, disposable gloves and stool collection device, and scheduled reminder on study. Receives: Other: Fecal Immunochemical Test; Behavioral: Health Education; Other: Scheduled Notification; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start20 Nov 2021
- Primary completion1 Feb 2022
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Mira Katz, Ohio State University Comprehensive Cancer Center
- Investigators
- Mira Katz, PhD, MPH, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810714
- Sponsor's protocol ID
- OSU-21213
- Other IDs
- NCI-2022-00144, R21AG061496
- Status last verified
- Dec 2023
- First submitted
- 31 Mar 2023
- Last updated
- 5 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Katz ML, Shoben AB, Newell S, Hall C, Emerson B, Gray DM 2nd, Chakraborty S, Reiter PL. Video brochures in a mailed fecal immunochemical test outreach program provide cancer screening information in a user-friendly format for rural Appalachian community members. J Rural Health. 2024 Jan;40(1):96-103. doi: 10.1111/jrh.12772. Epub 2023 Jun 9.
PubMed 37296510
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Increasing CRC Screening Using Audio and Video Brochures: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05810714
- Acronym / sponsor ID
- OSU-21213
- Conditions
- Colorectal Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 20 Nov 2021 (actual)
- Primary completion
- 1 Feb 2022 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 12 Apr 2023 (actual)
- Results
- Posted 5 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm I (FIT, usual care) | Active comparator | Other: Best Practice, Other: Fecal Immunochemical Test, Other: Survey AdministrationParticipants receive the FIT kit and usual care on study. |
| Arm II (FIT, audio brochure, reminder) | Experimental | Other: Fecal Immunochemical Test, Behavioral: Health Education, Other: Scheduled Notification, Other: Survey AdministrationParticipants receive the FIT kit with an audio brochure, disposable gloves and stool collection device, and scheduled reminder on study. |
| Arm III (FIT, video brochure, reminder) | Experimental | Other: Fecal Immunochemical Test, Behavioral: Health Education, Other: Scheduled Notification, Other: Survey AdministrationParticipants receive the FIT kit with a video brochure, disposable gloves and stool collection device, and scheduled reminder on study. |
Who may qualify
- Ages
- 50 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Best PracticeAlso: standard of care, standard therapyReceive usual care | Other | Arm I (FIT, usual care) |
| Fecal Immunochemical TestAlso: FIT, iFOBT, immunoassay fecal occult blood test, immunochemical fecal occult blood testReceive FIT kit | Other | Arm I (FIT, usual care), Arm II (FIT, audio brochure, reminder), Arm III (FIT, video brochure, reminder) |
| Health EducationReceive audio brochure | Behavioural | Arm II (FIT, audio brochure, reminder) |
| Health EducationReceive video brochure | Behavioural | Arm III (FIT, video brochure, reminder) |
| Scheduled NotificationAlso: ScheduledNotificationReceive scheduled reminder | Other | Arm II (FIT, audio brochure, reminder), Arm III (FIT, video brochure, reminder) |
| Survey AdministrationAncillary studies | Other | Arm I (FIT, usual care), Arm II (FIT, audio brochure, reminder), Arm III (FIT, video brochure, reminder) |
Primary outcome
Number of Participants to Return Fecal Immunochemical Test (FIT)
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 37296510Katz ML, Shoben AB, Newell S, Hall C, Emerson B, Gray DM 2nd, Chakraborty S, Reiter PL. Video brochures in a mailed fecal immunochemical test outreach program provide cancer screening information in a user-friendly format for rural Appalachian community members. J Rural Health. 2024 Jan;40(1):96-103. doi: 10.1111/jrh.12772. Epub 2023 Jun 9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mira Katz, PhD, MPH principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Best Practice, Fecal Immunochemical Test and Health Education in people with Colorectal Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants to Return Fecal Immunochemical Test (FIT) (time frame: At 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05810714, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2023.