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

8. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Geschätzt)

50

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

  • Name: Stephanie Larson
  • Telefonnummer: 715-838-1976

Studienorte

  • Vereinigte Staaten
    • Wisconsin
      • Eau Claire, Wisconsin, Vereinigte Staaten, 54701
        • Rekrutierung
        • Mayo Clinic Health System-Eau Claire Clinic
        • Hauptermittler:
          • Pravesh Sharma, MD
        • Kontakt:
        • Kontakt:
          • Stephanie Larson
          • Telefonnummer: 715-838-1976

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Sonstiges: Educational Intervention
Attend education sessions at WE-CARE forum
Andere Namen:
  • Erziehung zum Eingreifen
  • Intervention durch Bildung
  • Intervention, pädagogisch
Verhalten: Patient Navigation
Receive navigation support
Andere Namen:
  • Patientennavigationsprogramm
Sonstiges: Supportive Care
Attend storytelling sessions at WE-CARE forum
Andere Namen:
  • Unterstützende Therapie
  • Symptommanagement
  • Therapie, unterstützend

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Recruitment yield
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in breast cancer screening intention
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Mayo Clinic

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

5. Januar 2026

Primärer Abschluss (Geschätzt)

30. Januar 2028

Studienabschluss (Geschätzt)

30. Januar 2028

Studienanmeldedaten

Zuerst eingereicht

3. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

8. Juni 2026

Zuerst gepostet (Tatsächlich)

12. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

12. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

8. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 25-008934

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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