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Colorectal CancerNCT05903885

A Cross-sectional Partnership to Improve Prevention and Health Equity Among African Americans

A study testing On-site Fecal Immunochemical Test (FIT) Kit Distribution and On-site With Social Media Advertising Fecal Immunochemical Test (FIT) Kit Distribution in people with Colorectal Cancer and Prevention, run by University of Nebraska at 2 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

African Americans face racial disparities in colorectal cancer (CRC), with lower screening rates and higher incidence and mortality rates. To address this gap and improve CRC screening rates, investigators aims to recruit a total of 1,200 African American participants aged 45-75 during their visits to the DMV, 4606 N… Read more about this study

Who is it for?
Ages 45 to 75 yearsHealthy volunteers can take part
Conditions the study is for
Colorectal Cancer, Prevention
What is being tested?
On-site Fecal Immunochemical Test (FIT) Kit Distribution and On-site With Social Media Advertising Fecal Immunochemical Test (FIT) Kit Distribution
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,200 participants
Where
2 sitesUnited States
Study dates
2 Oct 2023to Oct 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

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 45 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Self-identification as Black or African American
  • Between 45 and 75 years old
  • Not up-to-date with colorectal cancer (CRC) screening per guidelines
  • Willingness to provide contact information for follow-up
  • Ability to speak, read, and write English
  • Current residency in Douglas County, NE.

Who cannot join

  • History of colorectal cancer (CRC)
  • History of adenomas (precancerous polyps) or inflammatory bowel disease
  • Family history of colorectal cancer (CRC)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Department of Motor Vehicles (DMV)

    Omaha, Nebraska, 68104

  • Douglas County Treasurer's Office

    Omaha, Nebraska, 68104

Other trials in United States

About this study

Official title: Using a Cross-sectional Partnership to Improve Prevention and Health Equity Among African Americans

African Americans face racial disparities in colorectal cancer (CRC), with lower screening rates and higher incidence and mortality rates. To address this gap and improve CRC screening rates, investigators aims to recruit a total of 1,200 African American participants aged 45-75 during their visits to the DMV, 4606 N 56th St Ste100, Omaha, for CRC screening. All participants will receive a free Fecal Immunochemical Test (FIT) kit with a prepaid return envelope, a culturally tailored educational brochure, reminder text messages and calls, and post-FIT navigation support for participants with positive results or without family doctor/insurance. Kits are returned to a designated Nebraska Medicine lab for testing, and test results will be mailed to participants within 14-21 days. Participants will be assigned to one of two groups: the on-site distribution group or the on-site distribution group with social media advertising group. The social media advertising group will additionally be exposed to targeted ads on platforms like Facebook, Instagram, and YouTube to increase awareness and potentially improve participation rates. The study will compare FIT kit return rates, positive screening rates, and completion rates of follow-up colonoscopies after positive FIT results between the two groups.

Read the detailed description

African Americans face racial disparities in colorectal cancer (CRC), with lower screening rates and higher incidence and mortality rates. The American Cancer Society reported that African Americans are about 20% more likely to have CRC and 40% more likely to die from it compared to other racial groups. The main reasons for high CRC incidence and mortality for African Americans are structural barriers in access to quality healthcare and timely screening that can be attributed in large part to historical and persistent structural racism in the U.S. To address this gap and improve CRC screening rates among African Americans, this study will partner with the Department of Motor Vehicles (DMV) to recruit African Americans eligible for CRC screening during their regular visits to the DMV. Investigators will recruit 1,200 participants aged 45-75 for CRC screening.

Upon consent, participants' demographic and screening-related information will be collected via a paper-based registration survey (e.g., name, age, gender, race/ethnicity, address, healthcare access, recent CRC screening history, smoking status, and personal/family history of CRC). All participants will receive a free Fecal Immunochemical Test (FIT) kit with a prepaid return envelope, a culturally tailored educational brochure, reminder text messages and calls. Participants will be assigned to one of two groups: the on-site distribution group or the on-site distribution group with social media advertising group. The social media advertising group will additionally be exposed to targeted ads on platforms like Facebook, Instagram, and YouTube from August 19, 2024, to October 29, 2024, to increase awareness and potentially improve participation rates.

Kits are returned to a designated Nebraska Medicine lab, and test results will be mailed to participants within 14-21 days. Follow-up services, including assistance with scheduling colonoscopies and applying for financial support programs, will be provided by a health navigator at Charles Drew Health Center for participants with positive results or those without health insurance or a primary care provider. Outcomes (screening completion rate and positive results) will be compared between the onsite and onsite with social media advertising groups, controlling for other covariates (age, gender, income, previous screening, smoking status, healthcare access, and health beliefs). The study will also assess the cost-effectiveness of each strategy and the completion rate of follow-up colonoscopies after receiving positive FIT results. Participants' perceptions and beliefs about screening will be collected via an online survey.

Being tested
On-site Fecal Immunochemical Test (FIT) Kit Distribution, On-site With Social Media Advertising Fecal Immunochemical Test (FIT) Kit Distribution
Keywords
Prevention, Department of motor vehicles, Cross-sectoral partnership, African Americans, Screening
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • On-site Fecal Immunochemical Test (FIT) Kit DistributionOther

    Also called Face-to-face distribution

    Participants will receive home based Fecal Immunochemical Test (FIT) kit directly at the Department of Motor Vehicles (DMV) location at 4606 N 56th St Suite 100, Omaha, NE 68104, by research staff.

  • On-site With Social Media Advertising Fecal Immunochemical Test (FIT) Kit DistributionOther

    Participants will receive home-based Fecal Immunochemical Test (FIT) kits directly at the Department of Motor Vehicles (DMV) location at 4606 N 56th St Suite 100, Omaha, NE 68104, by research staff supplemented by exposure to targeted social media advertisements.

Study groups in NCT05903885
Study groupRoleWhat they receive
On-site GroupExperimentalThe on-site distribution group will receive the Fecal Immunochemical Test (FIT) kits directly while visiting the Department of Motor Vehicles (DMV) location at 4606 N 56th St Suite 100, Omaha, NE 68104. Participants in the on-site group will be guided through the kit process by trained research staff present. They will be given instructions on collecting the stool sample and using the FIT kit properly. They will also be given a culturally tailored educational brochure, a prepaid return envelope, and receive reminder text messages and phone calls within 3 weeks of receipt of the FIT kit. Post-FIT navigation support will be provided for those with positive results or without a family doctor/insurance.
Receives: Other: On-site Fecal Immunochemical Test (FIT) Kit Distribution
On-site Group With Social Media AdvertisingActive comparatorThe onsite group with social media advertising participants will receive FIT kits directly at the Department of Motor Vehicles (DMV) location at 4606 N 56th St Suite 100, Omaha, NE 68104. Additionally, they will be exposed to targeted social media advertisements on Facebook, Instagram, and YouTube. These participants will encounter ads featuring video content with community member testimonials, emphasizing the importance of colorectal cancer screening for African Americans aged 45-75. The campaign will run from August 19 to October 29, 2024. Participants in this group will receive the FIT kits at the DMV along with detailed instructions on how to collect the stool sample and use the kit. They will also receive a culturally tailored educational brochure, prepaid return envelope, reminder text messages, and phone calls within three weeks of receipt of the FIT kit. Post-FIT navigation support will be provided for those with positive results or without a family doctor/insurance.
Receives: Other: On-site With Social Media Advertising Fecal Immunochemical Test (FIT) Kit Distribution

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fecal Immunochemical Test Kit Return Rate

    The fecal immunochemical test kit (FIT) return rate is the proportion of participants who have completed the screening by returning the FIT kits.

    Measured: 6 months from date of FIT distribution

Secondary outcomes (2)

  1. Fecal Immunochemical Test (FIT) Kit Positive Rate

    The fecal immunochemical test (FIT) kit positive rate is the proportion of participants who have positive FIT kit results.

    Measured: 6 months from date of FIT distribution

  2. Follow-up Colonoscopy Completion Rate

    The follow-up colonoscopy completion rate is the proportion of participants with positive FIT results who complete a follow-up colonoscopy.

    Measured: 6 months from date of positive FIT result notification

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Jun 2023
  2. Study start2 Oct 2023
  3. Primary completion1 Jun 2026
  4. Study completionOct 2026 (estimated)

Resources

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
Prevention
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
The study aims to enroll 600 participants to each of two groups to evaluate strategies in improving colorectal cancer screening rates among African Americans. The groups are the on-site group and the on-site group with social media advertising. The latter group will have exposure to targeted ads on Facebook, Instagram, and YouTube which will run from August 19 to October 29, 2024. The social media campaign will target African American residents of Omaha, aged 45-75. Both groups will be given fecal immunochemical test (FIT) kits, a prepaid return envelope, and an educational brochure when visiting the Department of Motor Vehicles (DMV), 4606 N 56th St Suite 100, Omaha, NE 68104. Both groups will also be given reminder messages and post-FIT navigation support, if needed. Participants' information and perceptions will be collected via surveys. FIT return rate, positive screening rate, and follow-up colonoscopy completion rate will be compared between groups, controlling for covariates.
Masking
Single blind
Who is masked
Participant
Enrolment
1,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05903885
Sponsor's protocol ID
0115-23-EP
Status last verified
Aug 2026
First submitted
5 Jun 2023
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Viale PH. The American Cancer Society's Facts & Figures: 2020 Edition. J Adv Pract Oncol. 2020 Mar;11(2):135-136. doi: 10.6004/jadpro.2020.11.2.1. Epub 2020 Mar 1. No abstract available.

    PubMed 33532112

  • American Cancer Society. Colorectal Cancer Facts and Figures 2020-2022. Atlanta, GA: 2022.

  • American Cancer Society. Key Statistics for Colorectal Cancer. 2022 [updated 1/12/2022; cited 2022 5/2]; Available from: https://www.cancer.org/cancer/colon-rectal-cancer/about/key-statistics.html

  • Mariotto AB, Yabroff KR, Shao Y, Feuer EJ, Brown ML. Projections of the cost of cancer care in the United States: 2010-2020. J Natl Cancer Inst. 2011 Jan 19;103(2):117-28. doi: 10.1093/jnci/djq495. Epub 2011 Jan 12.

    PubMed 21228314

  • Chen CT, Li L, Brooks G, Hassett M, Schrag D. Medicare Spending for Breast, Prostate, Lung, and Colorectal Cancer Patients in the Year of Diagnosis and Year of Death. Health Serv Res. 2018 Aug;53(4):2118-2132. doi: 10.1111/1475-6773.12745. Epub 2017 Jul 26.

    PubMed 28748564

  • Whitlock EP, Lin JS, Liles E, Beil TL, Fu R. Screening for colorectal cancer: a targeted, updated systematic review for the U.S. Preventive Services Task Force. Ann Intern Med. 2008 Nov 4;149(9):638-58. doi: 10.7326/0003-4819-149-9-200811040-00245. Epub 2008 Oct 6.

    PubMed 18838718

  • US Preventive Services Task Force; Bibbins-Domingo K, Grossman DC, Curry SJ, Davidson KW, Epling JW Jr, Garcia FAR, Gillman MW, Harper DM, Kemper AR, Krist AH, Kurth AE, Landefeld CS, Mangione CM, Owens DK, Phillips WR, Phipps MG, Pignone MP, Siu AL. Screening for Colorectal Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2016 Jun 21;315(23):2564-2575. doi: 10.1001/jama.2016.5989.

    PubMed 27304597

  • Wender RC, Doroshenk M, Brooks D, Hotz J, Smith RA. Creating and Implementing a National Public Health Campaign: The American Cancer Society's and National Colorectal Cancer Roundtable's 80% by 2018 Initiative. Am J Gastroenterol. 2018 Dec;113(12):1739-1741. doi: 10.1038/s41395-018-0384-1. Epub 2018 Nov 9. No abstract available.

    PubMed 30413821

  • National Cancer Institute. State Cancer Profiles: 2022.

  • Issaka RB, Taylor P, Baxi A, Inadomi JM, Ramsey SD, Roth J. Model-Based Estimation of Colorectal Cancer Screening and Outcomes During the COVID-19 Pandemic. JAMA Netw Open. 2021 Apr 1;4(4):e216454. doi: 10.1001/jamanetworkopen.2021.6454.

    PubMed 33843997

  • American Cancer Society. Colorectal Cancer Rates Higher in African Americans, Rising in Younger People. 2020 [cited 2022 5/2]; Available from https://www.cancer.org/latest-news/colorectal-cancer-rates-higher-in-african-americans-rising-in-younger-people.html#:~:text=Colorectal%20cancer%20also%20disproportionately%20affects,it%20than%20most%20other%20groups

  • Fedewa SA, Flanders WD, Ward KC, Lin CC, Jemal A, Goding Sauer A, Doubeni CA, Goodman M. Racial and Ethnic Disparities in Interval Colorectal Cancer Incidence: A Population-Based Cohort Study. Ann Intern Med. 2017 Jun 20;166(12):857-866. doi: 10.7326/M16-1154. Epub 2017 May 23.

    PubMed 28531909

  • Laiyemo AO, Doubeni C, Pinsky PF, Doria-Rose VP, Bresalier R, Lamerato LE, Crawford ED, Kvale P, Fouad M, Hickey T, Riley T, Weissfeld J, Schoen RE, Marcus PM, Prorok PC, Berg CD. Race and colorectal cancer disparities: health-care utilization vs different cancer susceptibilities. J Natl Cancer Inst. 2010 Apr 21;102(8):538-46. doi: 10.1093/jnci/djq068. Epub 2010 Mar 31.

    PubMed 20357245

  • Office of the Assistant Secretary for Planning and Evaluation, U.S. Department of Health and Human Services. Health Insurance Coverage and Access to Care Among Black Americans: Recent Trends and Key Challenges. (Issue Brief No. HP-2022-07). February 2022.

  • White A, Thompson TD, White MC, Sabatino SA, de Moor J, Doria-Rose PV, Geiger AM, Richardson LC. Cancer Screening Test Use - United States, 2015. MMWR Morb Mortal Wkly Rep. 2017 Mar 3;66(8):201-206. doi: 10.15585/mmwr.mm6608a1.

    PubMed 28253225

Questions about this trial

What is this clinical trial studying?

A study testing On-site Fecal Immunochemical Test (FIT) Kit Distribution and On-site With Social Media Advertising Fecal Immunochemical Test (FIT) Kit Distribution in people with Colorectal Cancer and Prevention, run by University of Nebraska at 2 sites 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 6 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

This study is still under way. Results are not available in the source record yet.

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?

Fecal Immunochemical Test Kit Return Rate (time frame: 6 months from date of FIT distribution). 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 NCT05903885, which also lists 29 linked publications.

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 28 Sep 2026.

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