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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Health services research (WE-CARE forum) | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Intervention | Other | Attend education sessions at WE-CARE forum |
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| Measure | Description | Time Frame |
|---|---|---|
| Recruitment yield | Assessed via the number enrolled divided by the number of eligible participants approached. | At time of forum |
| Exposure reach (community level reach) | 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 | Assessed by the number of participants who complete 3-month follow-up. | From baseline to 3 months |
| Perceived participant satisfaction | 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 | 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 | Assessed by post-intervention focus groups and brief qualitative interviews. Results will be analyzed descriptively. | Immediately following completion of forum |
| Perceived acceptability - AIM |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in breast cancer screening intention | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pravesh Sharma, MD | Contact | 715-838-5369 | sharma.pravesh@mayo.edu | |
| Stephanie Larson | Contact | 715-838-1976 |
| Name | Affiliation | Role |
|---|---|---|
| Pravesh Sharma, MD | Mayo Clinic Health System-Eau Claire Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Health System-Eau Claire Clinic | Recruiting | Eau Claire | Wisconsin | 54701 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| Patient Navigation | Behavioral | Receive navigation support |
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| Supportive Care | Other | Attend storytelling sessions at WE-CARE forum |
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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 | 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 | 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 |
| Chang in breast cancer screening behavior |
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 | 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 | 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 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D018479 | Early Intervention, Educational |
| D004522 | Educational Status |
| D008722 | Methods |
| D062526 | Patient Navigation |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D002662 | Child Health Services |
| D003153 | Community Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D011314 | Preventive Health Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D008919 | Investigative Techniques |
| D018802 | Patient-Centered Care |
| D011320 | Primary Health Care |
| D003191 | Comprehensive Health Care |
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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