- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07644702
WE-CARE Community Health Forums to Increase Breast Cancer Screening and Clinical Trial Participation for Rural and Low Income Women
8. juni 2026 opdateret af: Mayo Clinic
A Community Engagement Approach to Increasing Breast Cancer Screening and Clinical Trial Participation in Low Income and Rural Populations ('WE-CARE')
This clinical trial tests how well the Women's Engagement for Cancer Awareness, Resources, and Education (WE-CARE) community health forums work to increase breast cancer screening and clinical trial participation for rural and low income women.
Despite advances in breast cancer diagnosis and treatment in the past decade, rural-dwelling and underserved women, and Black, Indigenous, and people of color continue to experience low rates of breast cancer screening.
Since the survival rate for breast cancer is largely dependent on stage at which it is diagnosed, later stage breast cancer is correlated to a poorer prognosis and higher mortality rate.
The WE-CARE community health forms address structural barriers through culturally tailored educational sessions on breast cancer risk, screening and clinical trials, survivor storytelling to humanize cancer and research and patient navigation to facilitate mammogram screening and address barriers.
The WE-CARE community health forums may be an effective way to increase breast cancer screening and clinical trial participation for rural and low income women.
Studieoversigt
Status
Rekruttering
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
50
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Pravesh Sharma, MD
- Telefonnummer: 715-838-5369
- E-mail: sharma.pravesh@mayo.edu
Undersøgelse Kontakt Backup
- Navn: Stephanie Larson
- Telefonnummer: 715-838-1976
Studiesteder
-
-
Wisconsin
-
Eau Claire, Wisconsin, Forenede Stater, 54701
- Rekruttering
- Mayo Clinic Health System-Eau Claire Clinic
-
Ledende efterforsker:
- Pravesh Sharma, MD
-
Kontakt:
- Pravesh Sharma, MD
- Telefonnummer: 715-838-5369
- E-mail: sharma.pravesh@mayo.edu
-
Kontakt:
- Stephanie Larson
- Telefonnummer: 715-838-1976
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Female
- Be between the ages of 50 and 74 years
- Have no prior history of breast cancer screening (i.e., who have either never received a mammogram or have not had one in the past five years)
- Reside in a rural community in Wisconsin or belong to low income (self-reported)
- Be able to speak and understand English or Spanish
- Be willing and able to provide informed consent
Exclusion Criteria:
- Women who have received a mammogram within the past five years
- Have a current or prior diagnosis of breast cancer
- Are currently undergoing treatment for any active malignancy
- Have cognitive or psychiatric impairments that, in the judgment of the study team, would preclude meaningful participation
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Health services research (WE-CARE forum)
Patients attend a WE-CARE community forum, over 2 hours.
At the forum, patients attend educational sessions on breast cancer risk, screening and clinical trials as well as survivor storytelling sessions by community companions who have participated in clinical research for breast cancer.
Patients also receive navigation support to facilitate mammography, address barriers, support scheduling, coordinate follow-up, and provide real-time guidance on screening and matching with clinical trials or registries.
|
Attend education sessions at WE-CARE forum
Andre navne:
Receive navigation support
Andre navne:
Attend storytelling sessions at WE-CARE forum
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Recruitment yield
Tidsramme: At time of forum
|
Assessed via the number enrolled divided by the number of eligible participants approached.
|
At time of forum
|
|
Exposure reach (community level reach)
Tidsramme: At time of forum
|
Assessed by the number of attendees divided by the estimated number of population indirectly exposed (e.g., via flyers, social media, community announcements).
|
At time of forum
|
|
Retention
Tidsramme: From baseline to 3 months
|
Assessed by the number of participants who complete 3-month follow-up.
|
From baseline to 3 months
|
|
Perceived participant satisfaction
Tidsramme: Immediately following completion of forum
|
Success is defined as ≥ 75% of participants rating the experience ≥ 4 on a 5-point scale rated on a 5-point scale where 1=strongly disagree and 5=strongly agree.
Higher scores indicate greater perceived satisfaction.
|
Immediately following completion of forum
|
|
Perceived barriers to engagement and community impact
Tidsramme: Immediately following completion of forum
|
Assessed by post-intervention focus groups and brief qualitative interviews.
Results will be analyzed descriptively.
|
Immediately following completion of forum
|
|
Perceived facilitators to engagement and community impact
Tidsramme: Immediately following completion of forum
|
Assessed by post-intervention focus groups and brief qualitative interviews.
Results will be analyzed descriptively.
|
Immediately following completion of forum
|
|
Perceived acceptability - AIM
Tidsramme: Immediately following completion of forum
|
Assessed using the Acceptability of Intervention Measure (AIM), which consists of 4 items (e.g., meets my approval, is appealing to me) each rated on a 5-point scale where 1=strongly disagree and 5=strongly agree.
Higher scores indicate greater perceived acceptability.
|
Immediately following completion of forum
|
|
Perceived appropriateness - IAM
Tidsramme: Immediately following completion of forum
|
Assessed using the Intervention Appropriateness Measure (IAM), which consists of 4 items (e.g., seems fitting, seems like a good match) each rated on a 5-point scale where 1=strongly disagree and 5=strongly agree.
|
Immediately following completion of forum
|
|
Perceived feasibility - FIM
Tidsramme: Immediately following completion of forum
|
Assessed using the Feasibility of Intervention Measure (FIM), which consists of 4 items (e.g., seems implementable, seems easy to use) each rated on a 5-point scale where 1=strongly disagree and 5=strongly agree.
Higher scores indicate greater perceived acceptability.
|
Immediately following completion of forum
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in breast cancer screening intention
Tidsramme: Baseline, 3-month follow-up, 6-month follow-up
|
Assessed using the Risk Behavior Diagnosis Scale (RBDS), which consists of 12 items each rated on a 7-point scale where 1=strongly disagree and 7=strongly agree.
Higher scores reflect greater intention to engage in screening behavior.
|
Baseline, 3-month follow-up, 6-month follow-up
|
|
Chang in breast cancer screening behavior
Tidsramme: At 6 months post-forum
|
For participants who have never had a mammogram, a follow-up question at six months post-forum will document self-reported mammography completion.
Verification will be optional and used only to evaluate feasibility of data collection.
Results will be analyzed descriptively.
|
At 6 months post-forum
|
|
Perceived trust in medical researchers
Tidsramme: Baseline, 3-month follow-up, 6-month follow-up
|
Will be assessed using the Trust in Medical Researchers Scale, which consists of 4 items each rated on a 5-point scale where 1=strongly disagree and 5=strongly agree.
higher scores indicating greater perceived trust.
Results will be analyzed descriptively.
|
Baseline, 3-month follow-up, 6-month follow-up
|
|
Change in perceived research readiness
Tidsramme: Baseline, 3-month follow-up, 6-month follow-up
|
Indicators of research interest will be assessed using descriptively based on subsequent participant enrollment in observational research.
|
Baseline, 3-month follow-up, 6-month follow-up
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Pravesh Sharma, MD, Mayo Clinic Health System-Eau Claire Clinic
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Hjælpsomme links
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
5. januar 2026
Primær færdiggørelse (Anslået)
30. januar 2028
Studieafslutning (Anslået)
30. januar 2028
Datoer for studieregistrering
Først indsendt
3. juni 2026
Først indsendt, der opfyldte QC-kriterier
8. juni 2026
Først opslået (Faktiske)
12. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
12. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
8. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Neoplasmer efter sted
- Neoplasmer
- Hudsygdomme
- Brystsygdomme
- Hud- og bindevævssygdomme
- Brystneoplasmer
- Sundhedstjenester Administration
- Undersøgelsesteknikker
- Terapeutik
- Patientpleje
- Sundhedstjenester
- Sundhedsfaciliteter Arbejdsstyrke og tjenester
- Børns sundhedsydelser
- Fællesskabets sundhedsydelser
- Forebyggende sundhedsydelser
- Socioøkonomiske faktorer
- Befolkningsegenskaber
- Patientplejestyring
- Omfattende sundhedspleje
- Patientcentreret pleje
- Primær sundhedspleje
- Metoder
- Palliativ pleje
- Tidlig indgriben, uddannelsesmæssig
- Uddannelsesstatus
- Patientnavigation
Andre undersøgelses-id-numre
- 25-008934
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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