- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07644702
WE-CARE Community Health Forums to Increase Breast Cancer Screening and Clinical Trial Participation for Rural and Low Income Women
10 september 2026 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
1
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Wisconsin
-
Eau Claire, Wisconsin, Förenta staterna, 54701
- Mayo Clinic Health System-Eau Claire Clinic
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
Andra namn:
Receive navigation support
Andra namn:
Attend storytelling sessions at WE-CARE forum
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Recruitment yield
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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.
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Immediately following completion of forum
|
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Perceived barriers to engagement and community impact
Tidsram: 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
|
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Perceived facilitators to engagement and community impact
Tidsram: 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
Tidsram: 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
|
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Perceived appropriateness - IAM
Tidsram: 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.
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Immediately following completion of forum
|
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Perceived feasibility - FIM
Tidsram: 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
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in breast cancer screening intention
Tidsram: 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.
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Baseline, 3-month follow-up, 6-month follow-up
|
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Chang in breast cancer screening behavior
Tidsram: 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
|
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Perceived trust in medical researchers
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Pravesh Sharma, MD, Mayo Clinic Health System-Eau Claire Clinic
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Användbara länkar
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
30 juni 2026
Primärt slutförande (Faktisk)
10 september 2026
Avslutad studie (Faktisk)
10 september 2026
Studieregistreringsdatum
Först inskickad
3 juni 2026
Först inskickad som uppfyllde QC-kriterierna
8 juni 2026
Första postat (Faktisk)
12 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
14 september 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 september 2026
Senast verifierad
1 september 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Neoplasmer efter plats
- Neoplasmer
- Hudsjukdomar
- Bröstsjukdomar
- Hud- och bindvävssjukdomar
- Bröstneoplasmer
- Administration
- Undersökningstekniker
- Terapeutik
- Patientvård
- Vårdtjänster
- Sjukvårdsanläggningar och tjänster
- Barnhälsotjänster
- Gemenskapens hälsovård
- Förebyggande hälsovårdstjänster
- Socioekonomiska faktorer
- Befolkningsegenskaper
- Patientvårdshantering
- Omfattande vård
- Patientcentrerad vård
- Grundvård
- Metoder
- Palliativ vård
- Tidig intervention, pedagogisk
- Utbildningsstatus
- Patientnavigering
Andra studie-ID-nummer
- 25-008934
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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