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NCT Number: NCT07644702

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

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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Key information

Conditions

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

Age range

50 year–74 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic Health System-Eau Claire Clinic

Eau Claire, Wisconsin, 54701, United States

Location status: Recruiting

Location contact

Pravesh Sharma, MD

CONTACT

[email protected]

715-838-5369

Pravesh Sharma, MD

PRINCIPAL_INVESTIGATOR

Stephanie Larson

CONTACT

715-838-1976

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational Intervention

Other

Attend education sessions at WE-CARE forum

Other names: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational

Patient Navigation

Behavioral

Receive navigation support

Other names: Patient Navigator Program

Supportive Care

Other

Attend storytelling sessions at WE-CARE forum

Other names: Supportive Therapy, Symptom Management, Therapy, Supportive

Primary outcomes

  1. Recruitment yield

    Time frame: At time of forum

    Assessed via the number enrolled divided by the number of eligible participants approached.

  2. Exposure reach (community level reach)

    Time frame: 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).

  3. Retention

    Time frame: From baseline to 3 months

    Assessed by the number of participants who complete 3-month follow-up.

  4. Perceived participant satisfaction

    Time frame: 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.

  5. Perceived barriers to engagement and community impact

    Time frame: Immediately following completion of forum

    Assessed by post-intervention focus groups and brief qualitative interviews. Results will be analyzed descriptively.

  6. Perceived facilitators to engagement and community impact

    Time frame: Immediately following completion of forum

    Assessed by post-intervention focus groups and brief qualitative interviews. Results will be analyzed descriptively.

  7. Perceived acceptability - AIM

    Time frame: 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.

  8. Perceived appropriateness - IAM

    Time frame: 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.

  9. Perceived feasibility - FIM

    Time frame: 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

  1. Change in breast cancer screening intention

    Time frame: 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.

  2. Chang in breast cancer screening behavior

    Time frame: 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.

  3. Perceived trust in medical researchers

    Time frame: 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.

  4. Change in perceived research readiness

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Pravesh Sharma, MD

CONTACT

[email protected]

715-838-5369

Stephanie Larson

CONTACT

715-838-1976

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

A Community Engagement Approach to Increasing Breast Cancer Screening and Clinical Trial Participation in Low Income and Rural Populations ('WE-CARE')

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 12, 2026
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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