Community Gateway to Health Study
2. juli 2026 oppdatert av: Rebekka Lee, Harvard School of Public Health (HSPH)
The goal of this study is to evaluate the impact of a multi-level intervention on cancer prevention and social determinants of health outcomes.
This partnership between academic and community-based researchers aims to link community health centers and communities in ways that maximize both civic engagement and participation in cancer control care.
The system-level intervention consists of two components: (1) provision of community health center systems-level tools for cancer screening (breast, cervical, colorectal) and tobacco cessation treatment gaps; and (2) digital access screening and navigation.
These interventions will be delivered via usual care.
Studieoversikt
Status
Påmelding etter invitasjon
Forhold
Studietype
Intervensjonell
Registrering (Antatt)
100
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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-
Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Harvard TH Chan School of Public Health
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Springfield, Massachusetts, Forente stater, 01103
- Caring Health Center
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-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
Study participants include community health center and community partner staff participating in surveys and interviews about the implementation of the intervention.
Inclusion Criteria:
- Community health center staff or community partners
- Age 18 or older
Exclusion Criteria:
- Under 18
Patients will not be individually recruited for the study because the intervention is being offered as part of routine care.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Sekvensiell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Intervensjon på flere nivåer
|
This system level intervention consists of two components: (1) provision of community health center systems-level tools for cancer screening (breast, cervical, colorectal) and tobacco cessation treatment gaps; and (2) digital access screening and navigation.
This community level intervention consists of a patient referral from a community health center to a community organization focused on building social capital and civic engagement to test the impact of connecting clinical and community resources explicitly for patients.
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Ingen inngripen: Usual Care
In this stepped wedge design, all sites have a period of being in usual care.
Six sites then have periods of providing the intervention and six sites remain comparison sites (i.e.
usual care).
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Patients Screened for Colorectal Cancer
Tidsramme: change from baseline to end of intervention period, an average of 1 year
|
% patients who are up to date on colorectal cancer screening from EMR
|
change from baseline to end of intervention period, an average of 1 year
|
|
Patients Screened for Breast Cancer
Tidsramme: change from baseline to end of intervention period, an average of 1 year
|
% patients who are up to date on breast cancer screening from EMR
|
change from baseline to end of intervention period, an average of 1 year
|
|
Patients Screened for Cervical Cancer
Tidsramme: change from baseline to end of intervention period, an average of 1 year
|
% patients who are up to date on cervical cancer screening from EMR
|
change from baseline to end of intervention period, an average of 1 year
|
|
Patients Offered Pharmacotherapy for Smoking Cessation
Tidsramme: change from baseline to end of intervention period, an average of 1 year
|
% patients offered pharmacotherapy from EMR
|
change from baseline to end of intervention period, an average of 1 year
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Acceptability of the intervention
Tidsramme: Post intervention, 1 year follow up
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Self reported via staff survey
|
Post intervention, 1 year follow up
|
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Feasibility of the intervention
Tidsramme: Post intervention, 1 year follow up
|
Self-reported via staff survey
|
Post intervention, 1 year follow up
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
2. juni 2026
Primær fullføring (Antatt)
1. juni 2028
Studiet fullført (Antatt)
1. juli 2029
Datoer for studieregistrering
Først innsendt
4. mai 2026
Først innsendt som oppfylte QC-kriteriene
11. mai 2026
Først lagt ut (Faktiske)
18. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
2. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 241740
- U19CA291431 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Data that underlie the results reported here, after de-identification. Individual staff/partner data on implementation will be made publicly available.
Patient data can be made available upon request and appropriate approvals (see below).
IPD-delingstidsramme
Data will be stored for 7 years.
Tilgangskriterier for IPD-deling
Outside investigators will need an approved concept proposal to analyze study data and spend the requisite time with study staff to learn about the data elements needed to conduct the proposed analysis.
With the assistance from the study's analytic team, s/he will draft a detailed analysis plan and present to the core group of co-investigators.
The discussion at this meeting ensures adequate knowledge of the data, and the presenter gains much insight into how the analysis can be most useful and how it relates to previous analyses.
Once the plan is approved by this group, it must also be approved by the CHCs that provide the de-identified data.
Following approval by the appropriate IRBs and confirmation that it meets HIPAA requirements, s/he may sign a DUA to use a secure, de-identified dataset to complete only the approved analyses and write the manuscript(s) offsite.
A formal data analysis plan application and DUA are available.
Requests should be directed to jdaly@hsph.harvard.edu.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .