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

NCT07644702 | Recruiting

• 1 other identifier: 25-008934
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (4)

• Change in breast cancer screening intention

  Baseline, 3-month follow-up, 6-month follow-up

• Chang in breast cancer screening behavior

  At 6 months post-forum

• Perceived trust in medical researchers

  Baseline, 3-month follow-up, 6-month follow-up

Study Arms (1)

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.

Other: Educational Intervention; Behavioral: Patient Navigation; Other: Supportive Care

Interventions

Educational Intervention OTHER

Attend education sessions at WE-CARE forum

Also known as: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Health services research (WE-CARE forum)

Patient Navigation BEHAVIORAL

Receive navigation support

Also known as: Patient Navigator Program

Health services research (WE-CARE forum)

Supportive Care OTHER

Attend storytelling sessions at WE-CARE forum

Also known as: Supportive Therapy, Symptom Management, Therapy, Supportive

Health services research (WE-CARE forum)

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic Health System-Eau Claire Clinic

Eau Claire, Wisconsin, 54701, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Early Intervention, Educational; Educational Status; Methods; Patient Navigation; Palliative Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Socioeconomic Factors; Population Characteristics; Investigative Techniques; Patient-Centered Care; Primary Health Care; Comprehensive Health Care; Patient Care Management; Health Services Administration; Patient Care; Therapeutics

Study Officials

• Pravesh Sharma, MD

  Mayo Clinic Health System-Eau Claire Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pravesh Sharma, MD

CONTACT

715-838-5369; sharma.pravesh@mayo.edu

Stephanie Larson

CONTACT

715-838-1976

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2026
• First Posted: June 12, 2026
• Study Start: January 5, 2026
• Primary Completion (Estimated): January 30, 2028
• Study Completion (Estimated): January 30, 2028
• Last Updated: June 12, 2026

Record last verified: 2026-06

Locations

US (1)