A Community Engagement Approach to Increasing Breast Cancer Screening and Clinical Trial Participation in Low Income and Rural Populations ('WE-CARE')
| Registry | NCT07644702 |
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| Status | Terminated - Unable to reach enrollment target before the forum date of 9/17/2026 |
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| Phase | Not applicable |
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| Study type | Interventional; na, single group, masking: none, health services research |
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| Enrollment | 1 (Actual) |
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| Sponsor | Mayo Clinic (Other) |
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| Conditions | Breast Carcinoma |
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| Interventions | Educational Intervention, Patient Navigation, Supportive Care (Other, behavioral) |
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| Dates | start 2026-06-30, primary completion 2026-09-10, completion 2026-09-10, first posted 2026-06-12, last updated 2026-09-14 |
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| Locations | 1 site in United States |
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Related Papers Related Patents Related Grants Related Experts
All trials for Breast Carcinoma All trials of Educational Intervention All trials of Patient Navigation
-Summary
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.
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+Arms and interventions
| Arm | Type | Interventions | Description |
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| Health services research (WE-CARE forum) | Experimental | Other: Educational Intervention; Behavioral: Patient Navigation; Other: Supportive Care | 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. |
- Educational Intervention (Other), also known as Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational: Attend education sessions at WE-CARE forum
- Patient Navigation (Behavioral), also known as Patient Navigator Program: Receive navigation support
- Supportive Care (Other), also known as Supportive Therapy, Symptom Management, Therapy, Supportive: Attend storytelling sessions at WE-CARE forum
+Outcome measures
Primary outcomes
- Recruitment yield [At time of forum]: Assessed via the number enrolled divided by the number of eligible participants approached.
- Exposure reach (community level reach) [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).
- Retention [From baseline to 3 months]: Assessed by the number of participants who complete 3-month follow-up.
- Perceived participant satisfaction [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.
- Perceived barriers to engagement and community impact [Immediately following completion of forum]: Assessed by post-intervention focus groups and brief qualitative interviews. Results will be analyzed descriptively.
- Perceived facilitators to engagement and community impact [Immediately following completion of forum]: Assessed by post-intervention focus groups and brief qualitative interviews. Results will be analyzed descriptively.
- Perceived acceptability - AIM [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.
- Perceived appropriateness - IAM [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.
- Perceived feasibility - FIM [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.
Other outcomes
- Change in breast cancer screening intention [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.
- Chang in breast cancer screening behavior [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.
- Perceived trust in medical researchers [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.
- Change in perceived research readiness [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.
+Eligibility
Sex: Female, ages: 50 Years to 74 Years
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
+Locations (1)
| Facility | City | Country | Status |
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| Mayo Clinic Health System-Eau Claire Clinic | Eau Claire, Wisconsin | United States | |
+Investigators