Breast CarcinomaNCT07644702
WE-CARE Community Health Forums to Increase Breast Cancer Screening and Clinical Trial Participation for Rural and Low Income Women
A study testing Educational Intervention, Patient Navigation and Supportive Care in people with Breast Carcinoma, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 74 years, women only
- Conditions the study is for
- Breast Carcinoma
- What is being tested?
- Educational Intervention, Patient Navigation and Supportive Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2026to 10 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic Health System-Eau Claire Clinic
Eau Claire, Wisconsin, 54701
About this study
Official title: 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.
- Conditions
- Breast Carcinoma
- Being tested
- Educational Intervention, Patient Navigation, Supportive Care
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionOther
Also called Education for Intervention, Intervention by Education, Intervention through Education, Intervention, Educational
Attend education sessions at WE-CARE forum
Patient NavigationBehavioural
Also called Patient Navigator Program
Receive navigation support
Supportive CareOther
Also called Supportive Therapy, Symptom Management, Therapy, Supportive
Attend storytelling sessions at WE-CARE forum
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Educational Intervention; Behavioral: Patient Navigation; Other: Supportive Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment yield
Assessed via the number enrolled divided by the number of eligible participants approached.
Measured: 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).
Measured: At time of forum
Retention
Assessed by the number of participants who complete 3-month follow-up.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Immediately following completion of forum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2026
- Study start30 Jun 2026
- Primary completion10 Sep 2026
- Study completion10 Sep 2026
Why it stopped: Unable to reach enrollment target before the forum date of 9/17/2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pravesh Sharma, MD, Principal investigator, Mayo Clinic Health System-Eau Claire Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07644702
- Sponsor's protocol ID
- 25-008934
- Status last verified
- Sep 2026
- First submitted
- 3 Jun 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Community Engagement Approach to Increasing Breast Cancer Screening and Clinical Trial Participation in Low Income and Rural Populations ('WE-CARE')
- ClinicalTrials.gov ID
- NCT07644702
- Acronym / sponsor ID
- 25-008934
- Conditions
- Breast Carcinoma
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to reach enrollment target before the forum date of 9/17/2026
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 30 Jun 2026 (actual)
- Primary completion
- 10 Sep 2026 (actual)
- Study completion
- 10 Sep 2026 (actual)
- First posted
- 12 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health services research (WE-CARE forum) | Experimental | Other: Educational Intervention, Behavioral: Patient Navigation, Other: Supportive CarePatients 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. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionAlso: Education for Intervention, Intervention by Education, Intervention through Education, Intervention, EducationalAttend education sessions at WE-CARE forum | Other | Health services research (WE-CARE forum) |
| Patient NavigationAlso: Patient Navigator ProgramReceive navigation support | Behavioural | Health services research (WE-CARE forum) |
| Supportive CareAlso: Supportive Therapy, Symptom Management, Therapy, SupportiveAttend storytelling sessions at WE-CARE forum | Other | Health services research (WE-CARE forum) |
Primary outcome
Recruitment yield
Time frame: At time of forum
Assessed via the number enrolled divided by the number of eligible participants approached.
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).
Retention
Time frame: From baseline to 3 months
Assessed by the number of participants who complete 3-month follow-up.
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.
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.
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.
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.
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.
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.
Results and safety
The study was stopped early (reason given: Unable to reach enrollment target before the forum date of 9/17/2026). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pravesh Sharma, MD principal investigator
Mayo Clinic Health System-Eau Claire Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention, Patient Navigation and Supportive Care in people with Breast Carcinoma, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Unable to reach enrollment target before the forum date of 9/17/2026). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment yield (time frame: At time of forum). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.