Health Service Intervention for the Improvement of Access and Adherence to Colorectal Cancer Screening
Increasing Access and Developing Predictors for Colorectal Cancer Screening for Minority and Medicaid Clients
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
PRIMARY OBJECTIVES:
I. Test the feasibility of Witness CARES (WC) Services to achieve colorectal carcinoma (CRC) screening for non-adherent Medicaid clients.
II. Develop an algorithm for predicting CRC screening outcomes following intervention services.
OUTLINE:
Patients who are not prepared for a colonoscopy or stool test receive educational materials, messages, and videos electronically or by mail with information about colorectal screening and are followed up by phone within 2 weeks. Patients desiring colonoscopy receive navigator assistance with obtaining the screening (e.g.,determining gastrointestinal doctor, scheduling appointment, prep materials and process, transportation, escort). Patients desiring a stool test receive navigator assistance by facilitating fecal tests.
After completion of study, patients are followed up periodically.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 1
Contacten en locaties
Studie Locaties
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New York
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Buffalo, New York, Verenigde Staten, 14263
- Roswell Park Cancer Institute
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Participants who are non-adherent to CRC screening over the past year (i.e., no stool testing in past 11 months or colonoscopy for over 9 years)
- Medicaid or Medicaid/Medicare subscribers
- Uninsured patients may be included from Mercy Comprehensive Care Center (MCCC), but will only be eligible for services to obtain fecal immunochemical tests (FIT) through the New York State (NYS) Cancer Services Program
Exclusion Criteria:
- Any participants from the lists of gaps in care clients from insurance or primary care practices who report having had a colonoscopy in the past 9 years (or having positive findings such as polyps, 5 years) or having completed some type of fecal test for CRC will be excluded
- Participants under 50 will be excluded unless they have been deemed high risk by their physician, and have a prescription for CRC screening
- Participants symptomatic for CRC will be excluded from the study
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Health services research (Witness CARES services) Intervention
Patients who are not prepared for a colonoscopy or stool test receive educational materials, messages, and videos electronically or by mail with information about colorectal screening and are followed up by phone within 2 weeks.
Patients desiring colonoscopy, receive navigators assistance with obtaining the screening (e.g.,determining gastrointestinal doctor, scheduling appointment, prep materials and process, transportation, escort).
Patients desiring a stool test, receive navigators assistance by facilitating fecal tests.
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Nevenstudies
Receive Witness CARES services
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Screening Metrics
Tijdsspanne: Up to 12 months
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After CRC screening, satisfaction surveys will be conducted in order to assess the services of the Witness Cares Program. Below are responses to basic follow-up questions. |
Up to 12 months
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Model Development for Prediction of Intent and Colorectal Cancer (CRC) Screening Behaviors
Tijdsspanne: Up to 12 months
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A telephone assessment of 118 self reported questions will be conducted in order to assess what factors are associated with CRC screening. The outcome of interest is CRC screening (colonoscopy or fecal immunochemical testing (FIT) test), which is treated as a binary outcome. The potential predictors include basic demographic characteristics as well as the survey sub-scales (based on the 118 self-reported questions). |
Up to 12 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Prediction of Which CRC Screening Test is Most Acceptable
Tijdsspanne: Up to 12 months
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Data collected from surveys from the intent to screen clients will be used to help predict CRC screening test most acceptable
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Up to 12 months
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Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Deborah Erwin, Roswell Park Cancer Institute
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- I 63518 (Andere identificatie: Roswell Park Cancer Institute)
- P30CA016056 (Subsidie/contract van de Amerikaanse NIH)
- NCI-2019-06075 (Register-ID: CTRP (Clinical Trial Reporting Program))
- R41CA232824 (Subsidie/contract van de Amerikaanse NIH)
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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product vervaardigd in en geëxporteerd uit de V.S.
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