Colorectal CancerPRIMENCT06542835
Community Partnership for Telehealth Solutions to Convey Information and Enhance Care
A study testing Video text message, In-clinic CRC screening promotion and Mailed FIT in people with Colorectal Cancer, run by University of Arizona at 1 site in United States.
Trial summary
Non-randomized, two-arm stepped-wedge trial of a multi-level colorectal cancer screening intervention. Read more about this study
- Who is it for?
- Ages 45 to 64 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Video text message, In-clinic CRC screening promotion and Mailed FIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15,128 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2024to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult
Who may be able to join
- Ages 45-64
- Eligible for colorectal cancer (CRC) screening
- Current patients (seen in the clinic in the last 6 months)
- Primary speaker of English or Spanish
- Cell phone listed in Electronic Health Record (EHR)
- No recent history of CRC screening
- Resides in one of the neighborhoods included in the main trial
Who cannot join
- Colorectal disease (e.g., ulcerative colitis or colectomy)
- Personal history of colorectal cancer
- End-stage or life-threatening diseases
- Known to be under hospice care
- Living in a skilled nursing facility
- Patients who decline research participation will be removed from the patient contact list
Trial locations and contacts
1 site in 1 country.
United States1 site
AltaMed Health Services Corporation
Los Angeles, California, 90040
About this study
Official title: Community Partnership for Telehealth Solutions to Counter Misinformation and Achieve Equity
Non-randomized, two-arm stepped-wedge trial of a multi-level colorectal cancer screening intervention.
Read the detailed description
The PRIME study aims to improve colorectal cancer (CRC) screening and follow-up among predominantly Latinx populations by using video text messages, mailed FIT kits, and patient navigation. The study will address multi-level barriers to screening, including misinformation, lack of access, and social determinants of health. The hypothesis is that a multi-component intervention will increase CRC screening rates and follow-up care, reducing disparities in CRC outcomes.
- Conditions
- Colorectal Cancer
- Being tested
- Video text message, In-clinic CRC screening promotion, Mailed FIT, Social needs navigation, Reminders
- Keywords
- cancer screening, telehealth, video, text messaging, patient navigation, stool testing, fecal testing, Latinx health disparities
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video text messageBehavioural
Video text messages tailored to the Latinx population to educate and motivate patients to complete CRC screening.
In-clinic CRC screening promotionBehavioural
Stool-test orders, colonoscopy referrals.
Mailed FITBehavioural
Mailed FIT kits.
Social needs navigationBehavioural
Patient navigation to address social needs.
RemindersBehavioural
Centralized text and/or telephone reminders for ordered tests.
| Study group | Role | What they receive |
|---|---|---|
| Video text message, mailed FIT, and social needs navigation | Experimental | Tailored video text message, mailed FIT, and navigation to address patients' social needs. Receives: Behavioral: Video text message; Behavioral: Mailed FIT; Behavioral: Social needs navigation |
| Usual care | Active comparator | Colorectal cancer (CRC) screening offers during in-person clinic visits. Receives: Behavioral: In-clinic CRC screening promotion; Behavioral: Reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
CRC Screening Completion at the Individual Level
Measure the completion rate of colorectal cancer (CRC) screening at the individual level within 6 months of receiving the intervention. This will compare the proportion of participants in the post-intervention group versus the pre-intervention group.
Measured: 6 months
Secondary outcomes (3)
FIT completion
Measure the completion rate of fecal immunochemical tests (FIT) within 6 months of receiving the intervention. This will compare the proportion of participants who complete FIT in the post-intervention group versus the pre-intervention group.
Measured: 6 months
Rate of Follow-Up Colonoscopy Completion
Track the completion rate of follow-up colonoscopy within 12 months for participants with abnormal FIT results, comparing the post-intervention versus pre-intervention groups.
Measured: 12 months
Time to follow-up colonoscopy
Measure the time from abnormal FIT result to the completion of follow-up colonoscopy, comparing the post-intervention versus the pre-intervention groups.
Measured: Within 12 months post abnormal FIT result
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start31 Jul 2024
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University of ArizonaThe 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 15,128 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Collaborators
- San Diego State University, AltaMed Health Services Corporation, Kaiser Permanente
- Responsible party
- Principal investigator, Gloria Coronado, University of Arizona
- Investigators
- Anne Escaron, PhD, Principal investigator, AltaMed Health Services Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542835
- Sponsor's protocol ID
- STUDY00004612
- Acronym
- PRIME
- Status last verified
- Oct 2026
- First submitted
- 19 Jul 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rivelli JS, Schneider JL, Vaughn KA, Locher BW, Shaw MC, Martinez LS, Ruiz E, Thompson JH, Escaron AL, Coronado GD. Improving animated instructional videos for colorectal cancer screening: An application of learner verification and revision. Transl Behav Med. 2025 Jan 16;15(1):ibaf020. doi: 10.1093/tbm/ibaf020.
PubMed 40526315
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community Partnership for Telehealth Solutions to Counter Misinformation and Achieve Equity
- ClinicalTrials.gov ID
- NCT06542835
- Acronym / sponsor ID
- PRIME / STUDY00004612
- Conditions
- Colorectal Cancer
- Keywords
- cancer screening, telehealth, video, text messaging, patient navigation, stool testing, fecal testing, Latinx health disparities
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15,128 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Collaborators
- San Diego State University, AltaMed Health Services Corporation, Kaiser Permanente
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- 30 Sep 2026 (actual)
- Study completion
- 30 Sep 2026 (actual)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Non-randomized, two-arm stepped-wedge trial of a multi-level colorectal cancer screening intervention.
Detailed description
The PRIME study aims to improve colorectal cancer (CRC) screening and follow-up among predominantly Latinx populations by using video text messages, mailed FIT kits, and patient navigation. The study will address multi-level barriers to screening, including misinformation, lack of access, and social determinants of health. The hypothesis is that a multi-component intervention will increase CRC screening rates and follow-up care, reducing disparities in CRC outcomes.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video text message, mailed FIT, and social needs navigation | Experimental | Behavioral: Video text message, Behavioral: Mailed FIT, Behavioral: Social needs navigationTailored video text message, mailed FIT, and navigation to address patients' social needs. |
| Usual care | Active comparator | Behavioral: In-clinic CRC screening promotion, Behavioral: RemindersColorectal cancer (CRC) screening offers during in-person clinic visits. |
Who may qualify
- Ages
- 45 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Ages 45-64
- Eligible for colorectal cancer (CRC) screening
- Current patients (seen in the clinic in the last 6 months)
- Primary speaker of English or Spanish
- Cell phone listed in Electronic Health Record (EHR)
Key exclusion criteria (6 listed)
- Colorectal disease (e.g., ulcerative colitis or colectomy)
- Personal history of colorectal cancer
- End-stage or life-threatening diseases
- Known to be under hospice care
- Living in a skilled nursing facility
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 |
|---|---|---|
| Video text messageVideo text messages tailored to the Latinx population to educate and motivate patients to complete CRC screening. | Behavioural | Video text message, mailed FIT, and social needs navigation |
| In-clinic CRC screening promotionStool-test orders, colonoscopy referrals. | Behavioural | Usual care |
| Mailed FITMailed FIT kits. | Behavioural | Video text message, mailed FIT, and social needs navigation |
| Social needs navigationPatient navigation to address social needs. | Behavioural | Video text message, mailed FIT, and social needs navigation |
| RemindersCentralized text and/or telephone reminders for ordered tests. | Behavioural | Usual care |
Primary outcome
CRC Screening Completion at the Individual Level
Time frame: 6 months
Measure the completion rate of colorectal cancer (CRC) screening at the individual level within 6 months of receiving the intervention. This will compare the proportion of participants in the post-intervention group versus the pre-intervention group.
3 secondary outcomes
FIT completion
Time frame: 6 months
Rate of Follow-Up Colonoscopy Completion
Time frame: 12 months
Time to follow-up colonoscopy
Time frame: Within 12 months post abnormal FIT result
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- Derived from this study: PubMed 40526315Rivelli JS, Schneider JL, Vaughn KA, Locher BW, Shaw MC, Martinez LS, Ruiz E, Thompson JH, Escaron AL, Coronado GD. Improving animated instructional videos for colorectal cancer screening: An application of learner verification and revision. Transl Behav Med. 2025 Jan 16;15(1):ibaf020. doi: 10.1093/tbm/ibaf020.
- 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.
Anne Escaron, PhD principal investigator
AltaMed Health Services Corporation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video text message, In-clinic CRC screening promotion and Mailed FIT in people with Colorectal Cancer, run by University of Arizona 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 7 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 16 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CRC Screening Completion at the Individual Level (time frame: 6 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 NCT06542835, 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 16 Oct 2026.