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WE-CARE Community Health Forums to Increase Breast Cancer Screening and Clinical Trial Participation for Rural and Low Income Women

10. september 2026 oppdatert av: 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.

Studieoversikt

Status

Avsluttet

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

1

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Wisconsin
      • Eau Claire, Wisconsin, Forente stater, 54701
        • Mayo Clinic Health System-Eau Claire Clinic

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

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Annen: Educational Intervention
Attend education sessions at WE-CARE forum
Andre navn:
  • Utdanning for intervensjon
  • Intervensjon fra utdanning
  • Intervensjon gjennom utdanning
  • Intervensjon, pedagogisk
Atferdsmessig: Patient Navigation
Receive navigation support
Andre navn:
  • Pasientnavigatorprogram
Annen: Supportive Care
Attend storytelling sessions at WE-CARE forum
Andre navn:
  • Støttende terapi
  • Symptombehandling
  • Terapi, støttende

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Mayo Clinic

Etterforskere

  • Hovedetterforsker: Pravesh Sharma, MD, Mayo Clinic Health System-Eau Claire Clinic

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Hjelpsomme linker

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)

30. juni 2026

Primær fullføring (Faktiske)

10. september 2026

Studiet fullført (Faktiske)

10. september 2026

Datoer for studieregistrering

Først innsendt

3. juni 2026

Først innsendt som oppfylte QC-kriteriene

8. juni 2026

Først lagt ut (Faktiske)

12. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • 25-008934

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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