Colorectal CancerPhase 3NCT04941300
ColoRectal Cancer Screening for Southern California Community Health Centers
A Phase 3 study testing Mailed FIT Outreach and Standardized navigation in people with Colorectal Cancer, run by University of California, San Diego at 1 site in United States.
Trial summary
Colorectal cancer (CRC) screening can reduce cancer deaths. However, screening and abnormal test follow-up rates are low among underserved populations. The screening rates of 19-58%, and rates of colonoscopy completion after abnormal stool tests of 18-57% in community health centers (CHC) systems are low. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Mailed FIT Outreach and Standardized navigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55,999 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2021to 31 Aug 2024
- Phase
- Phase 3
- 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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Absence of a phone number listed in the Electronic Health Record/Electronic Medical Record (EMR)
- Absence of a valid mailing address (e.g. blank field)
- Uninsured
- Patients with a diagnosis or past history of total colectomy or colorectal cancer per UDS criteria.
- Duplicate patients within a health center organization. (If a patient was seen at multiple locations within the past year, only include the patient in the sample for the site where the patient was seen last)
- Care Coordination for Abnormal FIT results, add the following to the inclusion criteria:
- Completion of a FIT for Colorectal Cancer Screening during the designated time period
- Abnormal FIT result received and documented in EMR during the designated time period
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Diego, Moores Cancer Center
La Jolla, California, 92093
About this study
Official title: CRC-HUB-SPOKE: A ColoRectal Cancer Screening Hub for Southern California Community Health Centers
Colorectal cancer (CRC) screening can reduce cancer deaths. However, screening and abnormal test follow-up rates are low among underserved populations. The screening rates of 19-58%, and rates of colonoscopy completion after abnormal stool tests of 18-57% in community health centers (CHC) systems are low. This highlights an opportunity to improve early detection and decrease burden of CRC in our region. Mailed outreach and navigation programs have been shown to increase colonoscopy completion rate. The next step is to understand how to best implement these programs in the community on a larger scale. To achieve this goal, the investigators propose a Hub-and-Spoke intervention combining centralized strategies to maximize CRC screening, follow-up, and referral-to-care. The investigators hypothesize that this intervention will be superior to usual care for increasing CRC screening, abnormal test follow-up, and referral-to-care.
The investigators will conduct a randomized trial to determine effectiveness in: 1) improvement in proportion of individuals up-to-date with screening 3 years post implementation; 2) proportion with abnormal FIT who complete diagnostic colonoscopy within 6 months; and 3) proportion with CRC completing first treatment evaluation.
The investigators will also evaluate the implementation, scalability, and sustainability of the multi-level implementation strategy. The intervention consists of: Mailed FIT and Reminders. Eligible individuals will receive an introductory letter describing the importance of CRC screening and noting that follow-up mail will include a FIT Kit. It will also be offered to patients who completed prior mailed FIT with normal test results. All materials will be in English and Spanish. Two weeks later, participants will receive a packet via mail containing the FIT kit, a one-page invitation inviting FIT completion and FIT instructions, a postage-paid envelope for return to the patient's CHC, and COVID-19 message. For non-compliant individuals not returning the kit, a reminder phone call and text message will be delivered 2 weeks later. The investigators will track returned letters, individuals who are later found to be up-to date with screening, and those who decline screening. The CHC will provide care coordination for patients with an abnormal FIT result.
- Conditions
- Colorectal Cancer
- Being tested
- Mailed FIT Outreach, Standardized navigation
- Keywords
- screening, underserved populations
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mailed FIT OutreachOther
We will mail an introductory letter to eligible individuals describing the importance of CRC screening and noting that follow-up mail will include a FIT Kit. Two weeks later they will receive a packet via mail containing the FIT kit, a one-page invitation inviting FIT completion and FIT instructions, COVID-19 messaging, and a postage-paid envelope for return.
Standardized navigationOther
The standardized navigation includes, but is not limited to, the following key components:
- Identification of individuals with abnormal FIT
- Results review and colonoscopy order by provider
- Results reporting to patient
- Insurance approval for colonoscopy
- Colonoscopy scheduling
- Bowel preparation \& colonoscopy completion
- Colonoscopy results provided to patient and CHC
- Referral-to-Care for patients with CRC (if necessary)
| Study group | Role | What they receive |
|---|---|---|
| Mailed FIT Outreach | Other | Primer, FIT Kit, Reminders, Abnormal FIT Follow-up Receives: Other: Mailed FIT Outreach; Other: Standardized navigation |
| Usual Care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Screening up-to-date (primary)
Proportion of age-eligible patients with clinic visit in measurement year up-to-date with screening (FIT or FOBT in prior 12 months, sigmoidoscopy in last 5 years, colonoscopy in last 10 years).
Measured: Three years
Colonoscopy after abnormal FIT (primary)
Proportion of patients with abnormal FIT who complete colonoscopy within 6 months
Measured: Six months
Secondary outcomes (3)
FIT Completion
Proportion of patients who have FIT ordered as part of usual care or interventions who complete FIT within 12 months
Measured: Twelve months
Time to colonoscopy after abnormal FIT
Median time to colonoscopy completion after abnormal FIT
Measured: From date of abnormal FIT results until the date of colonoscopy completion, assessed up to 3 years
Follow-up process
Proportion of patients with abnormal FIT with a) colonoscopy ordered; b) insurance approval completed; c) precolonoscopy visit scheduled; d) precolonoscopy visit completed; e) adequate bowel preparation at time of colonoscopy; f) treatment evaluation referral initiated and first visit completed if CRC found.
Measured: From date of abnormal FIT results until the date of follow-up process is completed if a CRC is found, assessed up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2021
- Study start8 Jun 2021
- Primary completion31 Aug 2024
- Study completion31 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 California, San DiegoThe 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 3
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55,999 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Elena Martinez, University of California, San Diego
- Investigators
- Maria Elena Martinez, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04941300
- Sponsor's protocol ID
- IRB # 190990
- Other IDs
- 5UH3CA233314-05
- Status last verified
- Aug 2025
- First submitted
- 18 Jun 2021
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Martinez ME, Roesch S, Largaespada V, Nodora JN, Rabin BA, Castaneda SF, Covin J, Ortwine K, Preciado-Hidalgo Y, Howard N, Schultz J, Stamm N, Halpern MT, Gupta S. Fecal Immunochemical Test Outreach for Colorectal Cancer Screening in Community Health Centers: A Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2639013. doi: 10.1001/jamanetworkopen.2026.39013.
PubMed 42905707Largaespada V, Nodora JN, Covin J, Preciado-Hidalgo Y, Ortwine K, Howard N, Gupta S, Martinez ME, Roesch SC, Castaneda S, Rabin BA. Multi-method, longitudinal documentation of adaptations and their impact in the Accelerating Colorectal Cancer Screening and Follow-up through Implementation Science San Diego colorectal cancer screening implementation study. Transl Behav Med. 2026 Jan 7;16(1):ibag072. doi: 10.1093/tbm/ibag072.
PubMed 42837438Castaneda SF, Gupta S, Nodora JN, Largaespada V, Roesch SC, Rabin BA, Covin J, Ortwine K, Preciado-Hidalgo Y, Howard N, Halpern MT, Martinez ME. Hub-and-Spoke centralized intervention to optimize colorectal cancer screening and follow-up: A pragmatic, cluster-randomized controlled trial protocol. Contemp Clin Trials. 2023 Nov;134:107353. doi: 10.1016/j.cct.2023.107353. Epub 2023 Oct 5.
PubMed 37802222
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRC-HUB-SPOKE: A ColoRectal Cancer Screening Hub for Southern California Community Health Centers
- ClinicalTrials.gov ID
- NCT04941300
- Acronym / sponsor ID
- IRB # 190990
- Conditions
- Colorectal Cancer
- Keywords
- screening, underserved populations
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55,999 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 31 Aug 2024 (actual)
- First posted
- 28 Jun 2021 (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.
Colorectal cancer (CRC) screening can reduce cancer deaths. However, screening and abnormal test follow-up rates are low among underserved populations. The screening rates of 19-58%, and rates of colonoscopy completion after abnormal stool tests of 18-57% in community health centers (CHC) systems are low. This highlights an opportunity to improve early detection and decrease burden of CRC in our region. Mailed outreach and navigation programs have been shown to increase colonoscopy completion rate. The next step is to understand how to best implement these programs in the community on a larger scale. To achieve this goal, the investigators propose a Hub-and-Spoke intervention combining centralized strategies to maximize CRC screening, follow-up, and referral-to-care. The investigators hypothesize that this intervention will be superior to usual care for increasing CRC screening, abnormal test follow-up, and referral-to-care.
The investigators will conduct a randomized trial to determine effectiveness in: 1) improvement in proportion of individuals up-to-date with screening 3 years post implementation; 2) proportion with abnormal FIT who complete diagnostic colonoscopy within 6 months; and 3) proportion with CRC completing first treatment evaluation.
The investigators will also evaluate the implementation, scalability, and sustainability of the multi-level implementation strategy. The intervention consists of: Mailed FIT and Reminders. Eligible individuals will receive an introductory letter describing the importance of CRC screening and noting that follow-up mail will include a FIT Kit. It will also be offered to patients who completed prior mailed FIT with normal test results. All materials will be in English and Spanish. Two weeks later, participants will receive a packet via mail containing the FIT kit, a one-page invitation inviting FIT completion and FIT instructions, a postage-paid envelope for return to the patient's CHC, and COVID-19 message. For non-compliant individuals not returning the kit, a reminder phone call and text message will be delivered 2 weeks later. The investigators will track returned letters, individuals who are later found to be up-to date with screening, and those who decline screening. The CHC will provide care coordination for patients with an abnormal FIT result.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mailed FIT Outreach | Other | Other: Mailed FIT Outreach, Other: Standardized navigationPrimer, FIT Kit, Reminders, Abnormal FIT Follow-up |
| Usual Care | No intervention | – |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Absence of a phone number listed in the Electronic Health Record/Electronic Medical Record (EMR)
- Absence of a valid mailing address (e.g. blank field)
- Uninsured
- Patients with a diagnosis or past history of total colectomy or colorectal cancer per UDS criteria.
- Duplicate patients within a health center organization. (If a patient was seen at multiple locations within the past year, only include the patient in the sample for the site where the patient was seen last)
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 |
|---|---|---|
| Mailed FIT OutreachWe will mail an introductory letter to eligible individuals describing the importance of CRC screening and noting that follow-up mail will include a FIT Kit. Two weeks later they will receive a packet via mail containing the FIT kit, a one-page invitation inviting FIT completion and FIT instructions, COVID-19 messaging, and a postage-paid envelope for return. | Other | Mailed FIT Outreach |
| Standardized navigationThe standardized navigation includes, but is not limited to, the following key components: 1. Identification of individuals with abnormal FIT 2. Results review and colonoscopy order by provider 3. Results reporting to patient 4. Insurance approval for colonoscopy 5. Colonoscopy scheduling 6. Bowel preparation \& colonoscopy completion 7. Colonoscopy results provided to patient and CHC 8. Referral-to-Care for patients with CRC (if necessary) | Other | Mailed FIT Outreach |
Primary outcome
Screening up-to-date (primary)
Time frame: Three years
Proportion of age-eligible patients with clinic visit in measurement year up-to-date with screening (FIT or FOBT in prior 12 months, sigmoidoscopy in last 5 years, colonoscopy in last 10 years).
Colonoscopy after abnormal FIT (primary)
Time frame: Six months
Proportion of patients with abnormal FIT who complete colonoscopy within 6 months
3 secondary outcomes
FIT Completion
Time frame: Twelve months
Time to colonoscopy after abnormal FIT
Time frame: From date of abnormal FIT results until the date of colonoscopy completion, assessed up to 3 years
Follow-up process
Time frame: From date of abnormal FIT results until the date of follow-up process is completed if a CRC is found, assessed up to 3 years
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 26 Aug 2025.
- Derived from this study: PubMed 42905707Martinez ME, Roesch S, Largaespada V, Nodora JN, Rabin BA, Castaneda SF, Covin J, Ortwine K, Preciado-Hidalgo Y, Howard N, Schultz J, Stamm N, Halpern MT, Gupta S. Fecal Immunochemical Test Outreach for Colorectal Cancer Screening in Community Health Centers: A Randomized Clinical Trial. JAMA Netw Open. 2026 Oct 1;9(10):e2639013. doi: 10.1001/jamanetworkopen.2026.39013.
- Derived from this study: PubMed 42837438Largaespada V, Nodora JN, Covin J, Preciado-Hidalgo Y, Ortwine K, Howard N, Gupta S, Martinez ME, Roesch SC, Castaneda S, Rabin BA. Multi-method, longitudinal documentation of adaptations and their impact in the Accelerating Colorectal Cancer Screening and Follow-up through Implementation Science San Diego colorectal cancer screening implementation study. Transl Behav Med. 2026 Jan 7;16(1):ibag072. doi: 10.1093/tbm/ibag072.
- Derived from this study: PubMed 37802222Castaneda SF, Gupta S, Nodora JN, Largaespada V, Roesch SC, Rabin BA, Covin J, Ortwine K, Preciado-Hidalgo Y, Howard N, Halpern MT, Martinez ME. Hub-and-Spoke centralized intervention to optimize colorectal cancer screening and follow-up: A pragmatic, cluster-randomized controlled trial protocol. Contemp Clin Trials. 2023 Nov;134:107353. doi: 10.1016/j.cct.2023.107353. Epub 2023 Oct 5.
- Individual participant dataSharing planned: No
Related trials for Colorectal Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingObservational study
Pre- and On-treatment Multi-omics Profiling of Locally Advanced Rectal Cancer
Rectal Neoplasms
Enrolling by invitationObservational study
Natural History Study of Early Life Exposures in Agriculture (ELEA)
Prostate Cancer, Leukemia
RecruitingPhase 2
Tislelizumab in People With Colorectal Cancer
Colorectal Cancer
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.
Maria Elena Martinez principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Mailed FIT Outreach and Standardized navigation in people with Colorectal Cancer, run by University of California, San Diego 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 0 inclusion and 8 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 26 Aug 2025. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Screening up-to-date (primary) (time frame: Three years). The study lists 2 primary outcomes in all. 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 NCT04941300, which also lists 3 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 26 Aug 2025.