NCT04941300Befejeződött3. fázis
ColoRectal Cancer Screening for Southern California Community Health Centers
CRC-HUB-SPOKE: A ColoRectal Cancer Screening Hub for Southern California Community Health Centers
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2025. aug. 26.
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Befejeződött
- Fázis (regiszter)
- 3. fázis
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 55999 (tényleges)
- Első benyújtás
- 2021. jún. 18.
- Kezdés
- 2021. jún. 8.
- Elsődleges befejezés
- 2024. aug. 31.
- Fő szponzor
- University of California, San Diego
- Betegségek
- Vastagbélrák
- NCT-szám
- NCT04941300
Mit vállalsz
- Vizsgálat típusa: Beavatkozással járó · 3. fázis
- Bevont résztvevők: 55999
- 2021. jún. 8. és az elsődleges befejezés (2024. aug. 31.) között
- 1 helyszín, 1 országban
- Vizitek és vizsgálatok: kérdezd a vizsgálat csapatát, a regiszter nem sorolja fel őket
A(z) ClinicalTrials.gov regisztermezőiből összeállítva. A vizsgálat felépítését írja le.
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Korábbi kezelés
- Abnormal FIT result received and documented in EMR during the designated time period
Más betegség
- Patients with a diagnosis or past history of total colectomy or colorectal cancer per UDS criteria.
- Completion of a FIT for Colorectal Cancer Screening during the designated time period
Egyéb
- 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
- 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:
A regiszterben nem jelölt feltételek
- Mailed FIT Inclusion Criteria:
- Patient had an office visit within the last 12 months at one or more of your health centers. (Use Uniform Data System [UDS] criteria for an office visit.)
- Not up to date with colorectal cancer screening according to the standard UDS query
- Male or Female
- 50 - 75 years old
- Current VALID address in San Diego or Riverside Counties (addresses with a PO box or General Delivery are acceptable)
- Valid Phone Number
- Insured patients only (e.g., Medicare, Medi-Cal, or private insurance)
Életkor a regiszterben: 50 év – 75 év · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
Helyszínek (1)
Helyszínek a regiszter sorrendjében. Ha a profilodba mented a városodat, távolság szerint rendeződnek.
| Helyszín | Város | Ország | Helyszín állapota |
|---|---|---|---|
| University of California San Diego Moores Cancer Center | La Jolla | Egyesült Államok | Ismeretlen állapot |
Kapcsolódó publikációk
- Fecal Immunochemical Test Outreach for Colorectal Cancer Screening in Community Health Centers: A Randomized Clinical Trial.JAMA Netw Open · 2026 · PMID 42905707
- 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 · PMID 42837438
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