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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Carcinoma
• Intervention / Treatment: Other: Educational Intervention; Behavioral: Patient Navigation; Other: Supportive Care

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pravesh Sharma, MD; Phone Number: 715-838-5369; Email: sharma.pravesh@mayo.edu
• Study Contact Backup: Name: Stephanie Larson; Phone Number: 715-838-1976

Study Locations

• United States
  • Wisconsin
    • Eau Claire, Wisconsin, United States, 54701
      • Recruiting
      • Mayo Clinic Health System-Eau Claire Clinic
      • Principal Investigator: Pravesh Sharma, MD
      • Contact: Pravesh Sharma, MD; Phone Number: 715-838-5369; Email: sharma.pravesh@mayo.edu
      • Contact: Stephanie Larson; Phone Number: 715-838-1976

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Other: Educational Intervention; Attend education sessions at WE-CARE forum; Other Names: Education for Intervention; Intervention by Education; Intervention through Education; Intervention, Educational; Behavioral: Patient Navigation; Receive navigation support; Other Names: Patient Navigator Program; Other: Supportive Care; Attend storytelling sessions at WE-CARE forum; Other Names: Supportive Therapy; Symptom Management; Therapy, Supportive

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Other Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Pravesh Sharma, MD, Mayo Clinic Health System-Eau Claire Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2026
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): January 30, 2028

Study Registration Dates

• First Submitted: June 3, 2026
• First Submitted That Met QC Criteria: June 8, 2026
• First Posted (Actual): June 12, 2026

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 8, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Health Services Administration; Investigative Techniques; Therapeutics; Patient Care; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Community Health Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Patient Care Management; Comprehensive Health Care; Patient-Centered Care; Primary Health Care; Methods; Palliative Care; Early Intervention, Educational; Educational Status; Patient Navigation
• Other Study ID Numbers: 25-008934

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No