Colorectal Cancer ScreeningTUNE-UPNCT04304001
Test Up Now Education Program
A study testing Community Health Advisor in people with Colorectal Cancer Screening, run by Florida A&M University at 1 site in United States.
Trial summary
This study will test the effectiveness of an outreach strategy to increase colorectal cancer screening in African Americans. The investigators will recruit 250 African Americans ages 45-64 years who are not up-to-date with colorectal cancer screening or have never been screened, with the goal to evaluate screening… Read more about this study
- Who is it for?
- Ages 45 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer Screening
- What is being tested?
- Community Health Advisor
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Apr 2021to 12 Feb 2024
- 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 45 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- are 45 years to 64 years of age
- self-identify as African American
- have a working cellphone or telephone
- are a resident of Florida
- are non-adherent with colorectal cancer screening guidelines (i.e., no stool-based tests > 9 months, no colonoscopy within 9 years, and no flexible sigmoidoscopy within 4 years)
- have no personal history of colorectal cancer, precancerous colorectal polyps, or inflammatory bowel disease (ulcerative colitis or Crohn's disease).
Who cannot join
- under 45 years or over 64 years of age
- do not self-identify as African American
- do not have a working cellphone or telephone
- not a resident of Florida
- are adherent with colorectal cancer screening guidelines (i.e., stool-based tests < 9 months, colonoscopy within 9 years, and flexible sigmoidoscopy within 4 years) or
- have a personal history of colorectal cancer, precancerous colorectal polyps, or inflammatory bowel disease (ulcerative colitis or Crohn's disease).
Trial locations and contacts
1 site in 1 country.
About this study
This study will test the effectiveness of an outreach strategy to increase colorectal cancer screening in African Americans. The investigators will recruit 250 African Americans ages 45-64 years who are not up-to-date with colorectal cancer screening or have never been screened, with the goal to evaluate screening knowledge, behavior, and intervention effects on colorectal cancer screening outcomes. Participants will be randomly assigned to the TUNE-UP intervention or a control group. The TUNE-UP intervention arm will utilize a community health advisor to encourage return of stool blood testing kits through cell phone outreach. The control group will receive educational materials about colorectal cancer screening plus a resource list but no community health advisor counseling support or cellphone / text contact. The primary study outcome is receipt of colorectal cancer screening (colonoscopy or Fecal Immunochemical Test) following the intervention. The secondary outcomes will include colorectal cancer screening knowledge, self-efficacy (confidence to receive colorectal cancer screening), intention to screen, and follow-up in the case of an abnormal test result. The research objective is to test the community health advisor intervention effectiveness for promoting stool blood testing as a preferred screening test in an under-screened African American population.
- Conditions
- Colorectal Cancer Screening
- Being tested
- Community Health Advisor, Usual care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Health AdvisorBehavioural
Intervention arm participants will receive one 45-minute face-to-face meeting followed by two phone calls in one-week intervals over a period of three weeks beginning within one month following baseline survey completion. These educational activities will include the use of National Cancer Institute colorectal cancer resources and materials, including a Screen to Save media presentation, and colorectal cancer brochures. The intervention will follow a conversation guide/standard script for intervention fidelity. Community Health Advisors will take notes following each interaction to document the call length and call details. Participants will receive an additional text message reminder once a week for an additional three weeks - with instructions for participants to text "yes" to confirm they received the message - for a total of six weeks of intervention delivery. The personalized text messages will include short messages about the benefits of colorectal cancer screening.
Usual careBehavioural
Control arm participants will receive a Fecal Immunochemical Test kit, a mailed targeted colorectal cancer brochure, and complete a follow-up telephone survey at 3- and 12-months after the mailing.
| Study group | Role | What they receive |
|---|---|---|
| Community Health Advisor | Experimental | Intervention arm participants will be scheduled to receive the Community Health Advisor intervention within 4 to 6 weeks after enrollment, a Fecal Immunochemical Test kit, a mailed targeted colorectal cancer brochure, and a follow-up telephone survey at 3- and 12-months post-intervention Receives: Behavioral: Community Health Advisor |
| Usual care | Active comparator | Control group participants will receive a Fecal Immunochemical Test kit, a mailed targeted colorectal cancer brochure, and complete a follow-up telephone survey at 3- and 12-months after the mailing. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Up to Date on Colorectal Cancer Screening
The colorectal cancer screening measure asks about completion of colonoscopy and blood stool tests. These tests are described prior to questions about completion of each test. The first question asks when was the most recent stool blood test (> 1 year but < 2 years ago; > 2 years but not more than 5 years ago; or > 5 years). The second question asks when was the most recent colonoscopy (a year ago or less; > 1 year but < 5 years ago; > 5 years but not more than 10 years ago; or > 10 years). Colorectal cancer screening receipt will be determined based on self-report and chart review to determine screening rates for each screening modality. Those answering a "a year ago or less" for the most recent stool blood test and "less than 10 years ago" for most recent colonoscopy are considered up to date.
Measured: 12 months
Secondary outcomes (2)
Colorectal Cancer Screening Knowledge Measure
Participants are asked four multiple choice questions and 10 True/False questions to test knowledge about colorectal cancer and colorectal cancer screening. The range of the scale is 0-14. Each answer is scored as correct or incorrect. A score of 11 to 14 is considered "high". A score of 7 to 10 is considered "average". A score less than 7 is considered "low."
Measured: 12 months
Colorectal Cancer Screening Self-Efficacy Scale
A validated 4-item measure of colorectal cancer screening self-efficacy (alpha = 0.82) asks participants to respond using a Likert scale about colorectal cancer screening test difficulty, finding time, ease of completing the test, and scheduling the test. Total scale scores range from 1 to 4. A score of 3 to 4 is considered "low self-efficacy" and a score of 1 to 2 is considered "high self-efficacy."
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2020
- Study start7 Apr 2021
- Primary completion12 Feb 2024
- Study completion12 Feb 2024
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 (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal Cancer ScreeningStudies of the same condition, open and under way.
- 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
- Model description
- Participants will be randomly assigned to the TUNE-UP intervention or a control group that will receive educational materials about colorectal cancer screening plus a resource list but no Community Health Advisor counseling support or cellphone / text contact like in the TUNE-UP Community Health Advisor intervention group.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Responsible party
- Sponsor
- Investigators
- Karam Soliman, PhD, Principal investigator, Florida A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04304001
- Sponsor's protocol ID
- FWA00005391
- Other IDs
- U54MD007582-34A1
- Acronym
- TUNE-UP
- Status last verified
- Apr 2024
- First submitted
- 24 Feb 2020
- Last updated
- 29 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data sharing will be overseen by the Principal Investigator. To facilitate sharing of data, study outcome publications from this colorectal cancer screening intervention study will provide email contact information for interested persons to obtain details on accessing de-identified data. The data sharing option will be available for at least 3 years following completion of the project, consistent with National Institutes of Health (NIH) policy on maintenance of study data. The investigator requesting the data will be required to submit a data request detailing the research question to be investigated, the specific variables necessary for the intended analyses, a list of individuals who will have access to the data, and proof of adequate training in the protection of human subjects for all individuals with access to data.
Publications
Luque JS, Kiros GE, Vargas MA, Ali A, Tawk R, Jackson DR, Dickey SL, Harris CM, Robinson T, Duncan B, Freeman J, Gwede CK, Wallace K. Effectiveness of a community health advisor colorectal cancer screening educational intervention on stool test completion in an African American primary care patient population: a pragmatic randomized controlled trial. BMC Glob Public Health. 2025 Jun 1;3(1):47. doi: 10.1186/s44263-025-00168-4.
PubMed 40450376Luque JS, Matthew OO, Jackson DR, Vargas MA, Austin T, Ali A, Kiros GE, Harris CM, Tawk R, Gwede CK, Wallace K, Jean-Pierre P. Assessing the effectiveness of a community health advisor plus screen to save educational intervention on stool-based testing adherence in an African American safety net clinic population: study protocol for a randomized pragmatic trial. Trials. 2022 Feb 15;23(1):151. doi: 10.1186/s13063-022-06076-4.
PubMed 35168640
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Test Up Now Education Program
- ClinicalTrials.gov ID
- NCT04304001
- Acronym / sponsor ID
- TUNE-UP / FWA00005391
- Conditions
- Colorectal Cancer Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Florida A&M UniversityUniversity, hospital or other
- Collaborators
- National Institute on Minority Health and Health Disparities (NIMHD)
- Study start
- 7 Apr 2021 (actual)
- Primary completion
- 12 Feb 2024 (actual)
- Study completion
- 12 Feb 2024 (actual)
- First posted
- 11 Mar 2020 (actual)
- Results
- Posted 29 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test the effectiveness of an outreach strategy to increase colorectal cancer screening in African Americans. The investigators will recruit 250 African Americans ages 45-64 years who are not up-to-date with colorectal cancer screening or have never been screened, with the goal to evaluate screening knowledge, behavior, and intervention effects on colorectal cancer screening outcomes. Participants will be randomly assigned to the TUNE-UP intervention or a control group. The TUNE-UP intervention arm will utilize a community health advisor to encourage return of stool blood testing kits through cell phone outreach. The control group will receive educational materials about colorectal cancer screening plus a resource list but no community health advisor counseling support or cellphone / text contact. The primary study outcome is receipt of colorectal cancer screening (colonoscopy or Fecal Immunochemical Test) following the intervention. The secondary outcomes will include colorectal cancer screening knowledge, self-efficacy (confidence to receive colorectal cancer screening), intention to screen, and follow-up in the case of an abnormal test result. The research objective is to test the community health advisor intervention effectiveness for promoting stool blood testing as a preferred screening test in an under-screened African American population.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to the TUNE-UP intervention or a control group that will receive educational materials about colorectal cancer screening plus a resource list but no Community Health Advisor counseling support or cellphone / text contact like in the TUNE-UP Community Health Advisor intervention group.
| Arm | Type | Receives |
|---|---|---|
| Community Health Advisor | Experimental | Behavioral: Community Health AdvisorIntervention arm participants will be scheduled to receive the Community Health Advisor intervention within 4 to 6 weeks after enrollment, a Fecal Immunochemical Test kit, a mailed targeted colorectal cancer brochure, and a follow-up telephone survey at 3- and 12-months post-intervention |
| Usual care | Active comparator | Behavioral: Usual careControl group participants will receive a Fecal Immunochemical Test kit, a mailed targeted colorectal cancer brochure, and complete a follow-up telephone survey at 3- and 12-months after the mailing. |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- are 45 years to 64 years of age
- self-identify as African American
- have a working cellphone or telephone
- are a resident of Florida
- are non-adherent with colorectal cancer screening guidelines (i.e., no stool-based tests > 9 months, no colonoscopy within 9 years, and no flexible sigmoidoscopy within 4 years)
Key exclusion criteria (6 listed)
- under 45 years or over 64 years of age
- do not self-identify as African American
- do not have a working cellphone or telephone
- not a resident of Florida
- are adherent with colorectal cancer screening guidelines (i.e., stool-based tests < 9 months, colonoscopy within 9 years, and flexible sigmoidoscopy within 4 years) or
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 |
|---|---|---|
| Community Health AdvisorIntervention arm participants will receive one 45-minute face-to-face meeting followed by two phone calls in one-week intervals over a period of three weeks beginning within one month following baseline survey completion. These educational activities will include the use of National Cancer Institute colorectal cancer resources and materials, including a Screen to Save media presentation, and colorectal cancer brochures. The intervention will follow a conversation guide/standard script for intervention fidelity. Community Health Advisors will take notes following each interaction to document the call length and call details. Participants will receive an additional text message reminder once a week for an additional three weeks - with instructions for participants to text "yes" to confirm they received the message - for a total of six weeks of intervention delivery. The personalized text messages will include short messages about the benefits of colorectal cancer screening. | Behavioural | Community Health Advisor |
| Usual careControl arm participants will receive a Fecal Immunochemical Test kit, a mailed targeted colorectal cancer brochure, and complete a follow-up telephone survey at 3- and 12-months after the mailing. | Behavioural | Usual care |
Primary outcome
Number of Participants Up to Date on Colorectal Cancer Screening
Time frame: 12 months
The colorectal cancer screening measure asks about completion of colonoscopy and blood stool tests. These tests are described prior to questions about completion of each test. The first question asks when was the most recent stool blood test (> 1 year but < 2 years ago; > 2 years but not more than 5 years ago; or > 5 years). The second question asks when was the most recent colonoscopy (a year ago or less; > 1 year but < 5 years ago; > 5 years but not more than 10 years ago; or > 10 years). Colorectal cancer screening receipt will be determined based on self-report and chart review to determine screening rates for each screening modality. Those answering a "a year ago or less" for the most recent stool blood test and "less than 10 years ago" for most recent colonoscopy are considered up to date.
2 secondary outcomes
Colorectal Cancer Screening Knowledge Measure
Time frame: 12 months
Colorectal Cancer Screening Self-Efficacy Scale
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40450376Luque JS, Kiros GE, Vargas MA, Ali A, Tawk R, Jackson DR, Dickey SL, Harris CM, Robinson T, Duncan B, Freeman J, Gwede CK, Wallace K. Effectiveness of a community health advisor colorectal cancer screening educational intervention on stool test completion in an African American primary care patient population: a pragmatic randomized controlled trial. BMC Glob Public Health. 2025 Jun 1;3(1):47. doi: 10.1186/s44263-025-00168-4.
- Derived from this study: PubMed 35168640Luque JS, Matthew OO, Jackson DR, Vargas MA, Austin T, Ali A, Kiros GE, Harris CM, Tawk R, Gwede CK, Wallace K, Jean-Pierre P. Assessing the effectiveness of a community health advisor plus screen to save educational intervention on stool-based testing adherence in an African American safety net clinic population: study protocol for a randomized pragmatic trial. Trials. 2022 Feb 15;23(1):151. doi: 10.1186/s13063-022-06076-4.
- Individual participant dataSharing planned: Yes. Data sharing will be overseen by the Principal Investigator. To facilitate sharing of data, study outcome publications from this colorectal cancer screening intervention study will provide email contact information for interested persons to obtain details on accessing de-identified data. The data sharing option will be available for at least 3 years following completion of the project, consistent with National Institutes of Health (NIH) policy on maintenance of study data. The investigator requesting the data will be required to submit a data request detailing the research question to be investigated, the specific variables necessary for the intended analyses, a list of individuals who will have access to the data, and proof of adequate training in the protection of human subjects for all individuals with access to data.
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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.
Karam Soliman, PhD principal investigator
Florida A&M University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Health Advisor in people with Colorectal Cancer Screening, run by Florida A&M University 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 6 inclusion and 6 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 29 Oct 2024. 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 29 Oct 2024). 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 Up to Date on Colorectal Cancer Screening (time frame: 12 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 NCT04304001, which also lists 2 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 29 Oct 2024.