WeCare intervention to improve breast cancer screening and research preparedness in rural and low-socioeconomic women: study protocol for a community-engaged feasibility trial

Abstract

Introduction

Women residing in rural areas or belonging to lower socioeconomic status (SES) strata experience disproportionately low rates of breast cancer screening, contributing to delayed diagnoses and poorer prognoses. In addition, their participation in clinical trials remains markedly limited, reducing opportunities to access preventive and screening interventions. Promoting research preparedness among women before disease onset may empower them to make informed decisions regarding their health and willingness to participate in clinical research with fewer emotional and logistical barriers.

Methods and analysis

This project applies a community-based participatory research approach to develop and refine the WeCARE (Women’s Engagement for Cancer Awareness, Resources and Education) intervention for women aged 50–74 years who have either never undergone breast cancer screening or have not received screening in the past 5 years and who reside in rural areas or belong to low SES groups. The intervention consists of two components. Component 1 is a single-day, in-person community forum that includes (a) an educational seminar led by an oncologist to address breast cancer risk and screening guidelines, (b) survivor storytelling to enhance emotional engagement and cultural resonance and (c) facilitated navigation to breast cancer screening and future research participation. Component 2 involves structured post-forum follow-up through multiple touchpoints (phone calls and mailed boosters) to reinforce knowledge, address barriers and support screening completion and research enrolment. Quantitative data (eg, screening completion, satisfaction and follow-up engagement) will be summarised using descriptive statistics to assess feasibility and reach on 50 participants. Qualitative feedback from participants will undergo thematic analysis to identify barriers, facilitators and perceived cultural relevance. Integrated mixed-method interpretation will inform iterative refinement of the WeCARE intervention and guide design of subsequent larger trials.

Ethics and dissemination

Approved by the Mayo Clinic Institutional Review Board (IRB #25–008934). All participants will provide informed consent. Procedures ensure confidentiality, cultural sensitivity and participant safety. Data will be stored in REDCap and disseminated through publications, conferences, local town halls and community reports.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• The study uses a community-based participatory research approach to ensure co-development, cultural tailoring and shared decision-making with the community.

• The approach is guided by two theoretical frameworks (the Extended Parallel Process Model and the Socio-Ecological Framework) to assess behavioural and emotional factors influencing screening intention.

• Enrolment below target is possible given historically low research participation among rural and low socioeconomic status women; partial enrolment would still yield valuable data on recruitment barriers and intervention acceptability to inform future trials.

• The Rural-Urban Commuting Area codes and the Housing-based Socioeconomic Status (HOUSES) index are proxies for access barriers and do not capture insurance status or out-of-pocket costs directly; the Wisconsin Well Woman Program collaboration helps concentrate recruitment towards women with financial and access-related barriers.

• Findings may not generalise beyond English-speaking women in Midwest cultural contexts; future adaptations will incorporate multilingual materials and broader outreach.

Introduction

Advancements in cancer treatment and screening over the past two decades have led to a decrease in cancer-related deaths in the US. However, these gains have not been equitable, and people who live in rural areas consistently have higher rates of cancer mortality.¹ Among all cancers, breast cancer is the most common cancer among women,² and the survival rate for breast cancer is largely dependent on the stage at diagnosis, with later-stage breast cancer correlating to a poorer prognosis.³ For example, women diagnosed with localised breast cancer have a 5-year survival rate of >99%, whereas those diagnosed with distant breast cancer have a 5-year survival rate of only 33%.⁴ Moreover, multiple US studies indicate that women of lower socioeconomic status (SES) experience significantly poorer breast cancer outcomes5,7 and are more likely to be diagnosed at later stages, experiencing more aggressive disease subtypes and receive limited medical treatment that follows established evidence-based practice guidelines.⁸

A critical factor that correlates with poor prognosis of breast cancer among women who belong to lower SES and reside in rural areas is poor breast cancer screening rates.⁹ It is well established that early detection of breast cancer through screening mammography enables earlier diagnosis and significantly improves overall survival.¹⁰ However, rural and low-income women face substantial social determinants of health barriers such as geographic isolation, poverty, limited education and limited access to insurance and healthcare resources¹¹ in obtaining these essential services compared with their urban counterparts, resulting in delayed detection and poorer cancer outcomes.^{11 12}

Moreover, people in rural areas and those with low SES have low rates of clinical trial participation that could provide an avenue to access screening^{13 14} and prevention interventions prior to their approval for routine clinical use. If patients from rural and low SES areas are not participating in clinical trials at similar rates as those who are socioeconomically advantaged and from urban areas, this trend may contribute to significant health disparities, which ultimately lead to one section of society suffering more than another and cause greater healthcare costs.¹⁵ Trialists have devoted considerable effort to improving women’s enrolment in clinical trials, primarily by conducting clinic-based outreach to those already diagnosed with cancer.¹⁶ While outreach to already diagnosed women provides an important channel for enhancing trial enrolment, much of the recruitment effort occurs at a relatively advanced stage of the patient journey (ie, post-diagnosis). As a result, limited attention has been paid to building participant awareness, research preparedness and informed decision-making earlier in the disease continuum¹⁷ (eg, at risk assessment or pre-diagnosis phases).

Prior studies demonstrate that socioeconomically disadvantaged and minority populations have lower research literacy and fewer opportunities to engage in clinical research due to geographic, informational and resource barriers.18,20 Consequently, limited research preparedness constrains their ability to evaluate and pursue trial participation when opportunities arise, perpetuating structural inequities in access to innovative cancer care and outcomes.^{21 22} Following a cancer diagnosis, patients often experience significant emotional distress and cognitive overload, which can hinder their ability to process complex information related to clinical trials. This psychological state may reduce their readiness or capacity to participate in research; therefore, promoting research preparedness prior to a cancer diagnosis is critical.^{23 24} Empowering women about clinical research processes early and prior to disease occurrence can overcome these emotional and functional barriers to trial enrolment and, in turn, improve both screening uptake and access to emerging therapies.¹⁶ Yet, few interventions have focused on community-engaged strategies to increase both breast cancer screening and research preparedness prior to diagnosis.

To address this gap, our proposal applies two theoretical frameworks. First, using the Extended Parallel Process Model (EPPM),²⁵ this study examines how perceived threat (personal assessment of one’s risk of developing breast cancer) and perceived efficacy jointly influence screening intentions. Efficacy within the EPPM framework has two dimensions: (1) response efficacy, the belief that the recommended action (eg, obtaining a mammogram) effectively reduces risk and (2) self-efficacy, the confidence in one’s ability to perform that action despite potential barriers such as cost, transportation or fear of results. When individuals perceive a substantial threat, they assess both types of efficacies to determine whether to act. The EPPM thus provides a theoretical basis for tailoring message framing and follow-up strategies to enhance both perceived threat and efficacy.

Second, the Socio-Ecological Framework (SEF)^{26 27} situates individual processes within multilevel community and system barriers. By leveraging proven engagement strategies such as community partnerships, breast cancer survivors storytelling and patient navigation to screening and ongoing research, we aim to strengthen individuals’ interpersonal connections (peers with similar experience), relationships with local organisations (eg, faith and healthcare institutions, Wisconsin Well Woman Program (WWWP) and societal elements (eg, local culture). This multilevel approach helps individuals identify various anchor points to create more effective and sustainable change when intervention is administered.

Through these tested theoretical models and outreach efforts, our aim is to raise awareness about breast cancer, facilitate screening engagement, encourage enrolment in the Mayo Clinic research registry and foster research preparedness for future clinical trials. To our knowledge, no prior intervention has combined community-engaged education, survivor storytelling and patient navigation within a theoretically grounded framework (EPPM+SEF) to both increase breast cancer screening and prepare underserved women for future research participation.

Question: can a community-engaged WeCARE (Women’s Engagement for Cancer Awareness, Resources and Education) intervention demonstrate feasibility and preliminary signals of change in breast cancer screening intention and uptake, trust in medical research and research participation readiness among women in rural areas and with low SES who are overdue for breast cancer screening?

Specific aims

Aim

Evaluate the feasibility, acceptability and implementation characteristics of the WeCARE community intervention among women in rural areas and those with low SES. Outcomes include recruitment yield (enrolled÷eligible approached), community reach (attendees÷estimated exposed population), retention (participants completing 3-month follow-up (T3) assessments÷enrolled), participant satisfaction and perceived acceptability, appropriateness and feasibility. Feasibility will be supported if predefined benchmarks are met for recruitment, retention, measure completion and implementation ratings.

Exploratory aim 1

Estimate preliminary directional change in theory-based determinants of breast cancer screening intention from baseline (pre-forum) (T0) to 3-month follow-up (T3). Constructs derived from the EPPM include perceived susceptibility, perceived severity, response efficacy, self-efficacy and intention measured using the Risk Behaviour Diagnosis Scale (RBDS). RBDS data will be used to estimate variability, internal consistency and directional signal. Mammography completion or scheduling at T3 will be reported descriptively to characterise behavioural progression and outcome variability for a future efficacy trial.

Exploratory aim 2

Assess the feasibility of measuring research trust and early research participation readiness among forum participants. Outcomes include change in trust in medical researchers (validated 4-item scale), expressed interest in research participation and documented observational study enrolment captured through navigator logs. Enrolment indicators will be summarised descriptively to estimate ascertainment feasibility and variability rather than to test intervention effects.

Methods and analysis

Study design and setting

This is a single-arm, prospective, community-engaged implementation study employing a community-based participatory research (CBPR) framework²⁸ to evaluate the feasibility, acceptability and implementation characteristics of the culturally tailored WeCARE intervention (forum and post-forum components) and to estimate preliminary signals of change in breast cancer screening intention, screening engagement, trust in medical research and research participation readiness among women in rural areas with low SES.

By the completion of this study, we will recruit approximately 50 participants (if this enrolment threshold of at least 70% is not met, a second forum will be conducted) from the local rural community in Eau Claire, Wisconsin, and nearby areas. The participant is not required to be a Mayo Clinic patient.

The project-specific community advisory board (CAB) will prepare advertisement, recruitment and study materials. The CAB for this project includes 10–12 members from the community who are adult females and invited through our established relationships with the local non-profit community organisations, Mayo Clinic social network (Mayo Clinic Connect) and word of mouth, if they meet the following criteria: (1) have been diagnosed with breast cancer and/or are breast cancer survivors, (2) live in a rural and/or low-income area (self-reported) and (3) are primary care physicians and oncologists interested in breast cancer treatment and research. The CAB compensation will be US$75 for each meeting of about 1 hour and targeted to have about 5–6 meetings during the project. Prior to starting the project, the CAB members will meet with the principal investigator for their role clarity and training (eg, orientation to EPPM/SEF frameworks) to strengthen equitable partnership and avoid tokenism. The CAB members will participate in dissemination activities including presenting at community events and co-authoring lay summaries.

If two forums are conducted, fidelity will be preserved by defining core components (EPPM-aligned education, survivor storytelling, patient navigation and research literacy invitation) that will not change across forums. Contextual elements (venue, timing, language level, case examples and childcare/travel supports) may be adapted from lessons learnt from the first forum with CAB input. All adaptations will be documented using the Framework for Reporting Adaptations and Modifications-Enhanced (FRAME),²⁹ specifying what was changed, who suggested it, when, why and with what effect on fidelity. A structured fidelity checklist (dose delivered, content adherence, delivery quality, participant receipt and enactment in the context of the forum) will be completed for each forum.

This study will be conducted at Mayo Clinic Health System (MCHS), Eau Claire campus. 53% of the census tracts within the MCHS service area are classified as rural, and 62% of patients at MCHS reside in rural communities.³⁰ The MCHS catchment area presents with rural health challenges, as characterised by high disease burden and patient flow, limited specialty access and growing need for health innovations. In addition, we are partnering with the WWWP.³¹ The WWWP is a federally funded program that provides coverage for screening services for low-income and uninsured women across Wisconsin.

Study population

Women will be recruited through a multimodal recruitment plan involving local partnerships, digital targeting and CAB-guided outreach plans. The participants are not required to be patients at Mayo Clinic/MCHS. Participants must (1) be 50–74 years old; (2) be eligible for breast cancer screening per the US Preventive Services Task Force³² guidelines but have either never undergone screening or have not received screening within the past 5 years; (3) self-identify as female by birth and (4) must reside in rural areas as defined by Rural-Urban Commuting Area (RUCA) codes³³ and/or be individuals classified as belonging to lower SES, as determined by the validated HOUSES (Housing-based Socioeconomic Status) index.³⁴

Design consideration

Because many women in rural and low-income communities lack a primary care provider (PCP),³⁵ this pilot will intentionally include participants both with and without an established PCP. For those without a PCP, the Clinical Research Coordinator (CRC) will provide tailored support to identify local screening resources or connect participants to safety-net clinics using WWWP and CAB-curated referral lists. Including participants without a PCP enhances the study’s pragmatic relevance by capturing real-world barriers and testing the feasibility of longitudinal tracking across diverse care contexts.

These inclusion criteria ensure representation from populations disproportionately affected by healthcare disparities. RUCA codes³³ provide a standardised method to classify rurality based on population density, urbanisation and commuting patterns, thereby capturing residents of small towns and outlying rural communities. The HOUSES index³⁴ is a validated, individual-level SES measure derived from publicly available housing data (eg, property value, square footage and number of bedrooms and bathrooms), allowing for a more precise assessment of socioeconomic disadvantage than traditional aggregate measures. Together, the combined use of RUCA codes and the HOUSES index enables the identification of participants who are either geographically or socioeconomically underserved, ensuring that the study meaningfully addresses disparities in access, utilisation and health outcomes.

Recruitment

The WeCARE intervention project will employ a community-engaged, multimodal recruitment strategy^{36 37} designed to reach participants who meet our inclusion criteria. Recruitment efforts and materials will be co-developed and iteratively refined in collaboration with the CAB, leveraging trusted networks and culturally tailored messaging.

Faith-based and civic organisation partnerships

We will engage local faith-based organisations, community centres and libraries to distribute information materials and host the forum.

Coordination with local community partner

Our collaborator, WWWP, will use their channels to identify eligible women in their networks who are overdue for screening and provide direct invitations. WWWP will assist in distributing informational brochures and pre-registering women interested in attending forums.

Peer-to-peer recruitment

Peer-to-peer recruitment by trusted community members has been shown to enhance trust, credibility and participation among target populations.³⁸ Therefore, a community advocate (eg, a woman who has previously participated in breast cancer screening or is a survivor) will also support recruitment efforts.

Media and print campaigns

We will use targeted advertisements on social media, emphasising the no-cost nature of the forum, availability of childcare and transportation and the connection to trusted programs like WWWP and Mayo Clinic.

Adaptive exposure plan

Exposures will be distributed initially as follows: ~35%–40% electronic health record (EHR), ~25%–30% community announcements, ~10%–25% mailed flyers/letters and ~10%–25% social media/digital shareables. Mailing addresses will be obtained from (1) the Mayo Clinic EHR for eligible patients (via limited data set extraction) and (2) community partners’ opt-in lists. No third-party commercial lists will be used. All addresses will be stored in REDCap, and mailings will be conducted through Mayo-approved secure vendors. After approximately 1000 exposures, we will examine channel-specific conversion rates (exposure to signing up for the forum) and reallocate towards higher-yield channels.3639,41

The advertising material will include a QR code linking to a screening or brief pre-enrolment form. This form will collect basic contact information and assess interest in attending a forum. Completion of the form will trigger a notification to the CRC, who will then follow up directly with interested individuals to provide study information and obtain informed consent, as appropriate. This approach ensures that outreach extends beyond current patients, enabling broader community engagement while maintaining appropriate study oversight and privacy protections.

Intervention

The WeCARE intervention will consist of two components (tables1 2): (1) a single-day, in-person community health forum lasting approximately 2 hours and (2) post-forum follow-up phone calls at 1 and 3 months to foster self-efficacy, address barriers and encourage engagement in breast cancer screening and research preparedness. Another forum will be planned if we do not reach our 70% attendance threshold for the first forum.

Table 1. In-person forum components and key features.

Component	Key features
Educational sessions	Brief presentations led by a breast oncologist regarding risk, screening guidelines and clinical trials (co-developed and refined with CAB for cultural relevance). Incorporates interactive discussion segments (small-group reflections, myth-busting Q&A and audience polling) to promote engagement and address misconceptions. Dispels treatment and clinical trial myths and outlines care pathways.
Survivor storytelling	Led by trained Community Companions (local breast cancer survivors who participated in a clinical trial) to humanise cancer and clinical research. Culturally grounded narratives created by Community Companions involve expressive story writing based on their lived experiences, followed by a story circle in which participants share early drafts with the CAB for feedback. The process culminates in final script development for forum presentation, designed to build trust and reduce stigma. Story-sharing and peer-dialogue formats to encourage discussion of personal experiences, stigma and coping strategies. Topics include diagnosis, healthcare and research experiences, treatment side effects, survivorship and maintaining quality of life.
Patient navigation	Screening navigation: facilitates mammography through PCPs, mobile units or trials; addresses barriers (transport and insurance); supports on-site scheduling and helps coordinate screening-related follow-up with the WWWP, Mayo Clinic or external healthcare providers. Research navigation: real-time guidance on screening and matching with screening-related clinical trials or observation studies/registries at Mayo Clinic.

CAB, community advisory board; PCP, primary care provider; Q&A, questions and answers; WWWP, Wisconsin Well Woman Program.

Table 2. Phone follow-up contacts and booster activities.

Timing	Activities	Purpose
T2	Support touch points: review screening experiences; identify barriers and discuss solutions; collaborate with Mayo Clinic clinicians and the WWWP to facilitate screening; assess eligibility for observational/clinical studies; invite participants to share experiences or micro-stories/testimonies that might encourage other women and gather feedback and data.	Gather feedback, resolve immediate challenges, ensure screening completion and engage in peer impact.
	Review mammogram status (if completed): • Positive result: coordinate diagnostic imaging; schedule specialty consultations; provide navigation for timely treatment; referrals for financial counselling, transportation, childcare or health literacy. • Negative result: reinforce the importance of routine screening; provide risk-reduction education; address residual concerns and connect to supportive resources.	Ensure timely diagnostic follow-up for abnormal findings; encourage continued adherence and promote health literacy.
Micro-booster mailing #1 (month 1.5)	Culturally tailored postcard/letter co-developed with the CAB; includes a brief peer quote or testimonial (“I finally got mine done”) with information on how to schedule a mammogram and how to contact the CRC.	Reinforce motivation through relatable peer modelling; maintain emotional connection between calls.
Micro-booster mailing #2 (month 2.5)*	‘Staying on track’ message emphasising pride, community and persistence; invites reflection (‘Share with a friend who might need this reminder’).	Encourage diffusion of positive norms (peer-to-peer encouragement).
T3	Reassess barriers and reinforce autonomy; close with gratitude and empowerment framing (‘You’re helping other women see what’s possible’). Offer ongoing contact or a peer advocate connection.	Sustain engagement and transition from navigator support to community ownership of health behaviour.

^*Implemented if resources permit and endorsed by the CAB.

CAB, community advisory board; CRC, clinical research coordinator; T2, 1-month follow-up (call); T3, 3-month follow-up (call); WWWP, Wisconsin Well Woman Program.

Forum

Each in-person forum includes three components (see table 1). A round table accommodating approximately eight participants will be arranged to facilitate engagement activities during the forum. This configuration promotes group learning, mutual sharing of experiences and interactive discussion. It is also designed to foster lasting connections among participants, enabling continued peer support beyond the forum and potential sustained engagement in health-promoting behaviours.

All intervention content will be co-developed with the CAB input that will include breast cancer specialists, survivors, faith and civic leaders and community engagement experts. Each forum will be supported by a dedicated Mayo Clinic CRC, available by phone, email or fax. The CRC will coordinate with the Mayo Clinic Mobile Mammography Van program to obtain advanced schedules of upcoming community visits. This information will be used to proactively facilitate mammography appointment scheduling for forum attendees, thereby directly linking forum participation to timely screening uptake and reinforcing the forums as action-oriented rather than informational alone. For uninsured or underinsured participants, WWWP will facilitate access to no-cost or low-cost screening through Mayo Clinic or its affiliates.

This approach reframes research participation not because of a life-threatening diagnosis, but as a parallel pathway to prevention and population health equity. Engaging screening-naïve and underscreened women in long-term observational studies and registries offers a feasible opportunity for future clinical trial participation. On-site resources, including childcare, transportation vouchers and snacks, will be provided for participants attending forum in person.

Post-forum

After the WeCARE forums, CRCs will maintain contact with participants through scheduled phone calls at 1 month (T2) and 3 months (T3), lasting about 15–20 min each, to provide continuity of engagement beyond the forum (table 2). These contacts will be used to reinforce the knowledge, skills and strategies introduced during the forums, encourage participants to take meaningful steps towards breast cancer screening, engage in ongoing problem-solving and address barriers to seeking appropriate care (transportation, cost, childcare, anxiety and appointment confusion). Through these follow-up calls, CRCs will also provide reminders for upcoming screenings and referrals to appropriate clinical or community resources as deemed necessary. For positive mammogram results, CRCs will coordinate with the WWWP to facilitate diagnostic imaging, specialty consultations and referrals for financial counselling, transportation, childcare and health-literacy support. For negative results, CRCs will reinforce routine screening intervals and evidence-based risk-reduction behaviours. This sustained communication is designed to foster trust, promote self-efficacy and ensure that the benefits of the forums translate into long-term health behaviour change. We will also incorporate two mailings, timed to ‘nudge’ action. Our follow-up schedule operationalises evidence-based components that have demonstrated efficacy in screening reminders.^{42 43}

Procedure

The data will be collected using secure electronic survey services. To facilitate participation, we have developed a brief pre-enrolment screening form that potential participants will complete when expressing interest in the forums and the study. Recognising that many participants will be from rural areas and may represent lower SES backgrounds, additional flexibility will be provided for these participants. They will have the option to call our CRC to review eligibility. Following enrolment, CRCs will contact participants by phone to conduct baseline assessments and data collection and schedule follow-up evaluations. This multimodal approach ensures inclusivity for participants with limited digital access while maintaining data integrity and completeness. The assessments will be conducted at multiple phases during the study: before the initiation of the intervention baseline (T0, pre-forum); immediately post-forum (T1); 1-month follow-up (T2) and 3 month follow-up (T3). At the baseline assessment (T0), the CRC will gather data such as sociodemographic factors, including age, education level, marital status, address and zip codes; employment status; family history of cancer; medical and psychiatric comorbidities and past 30-day drinking and smoking status. Insurance status and self-reported cost barriers to screening will also be collected at baseline, enabling post hoc characterisation of access-barrier profiles across participants recruited through different channels (eg, WWWP vs EHR or community outreach). If the participant is from Mayo Clinic, the CRCs will attempt to collect most of the information from the electronic medical record. No post-trial intervention is provided; participants receive standard community referrals and treatment after the completion of this trial.

Outcomes and measurements

Table 3 describes the outcomes of this study and the measurements used at the specific time points.

Table 3. Describes outcomes, measures used and time points.

Domain	Outcome/construct	Measure/instrument/data source	Time point(s)
Primary outcomes
Feasibility	Recruitment yield	Recruitment logs documenting the number contacted by CAB partners, clinic staff or research team and the number attending the WeCARE forum	Forum level
	Exposure reach (community-level reach)	Attendance logs and deduplicated recruitment records across indirect exposure channels (flyers, social media and community announcements)	Forum level
	Retention (participant engagement)	Attendance logs and survey completion records	T0–T3
Participant satisfaction (mixed-methods)	Satisfaction with forum content, delivery and cultural relevance	Structured post-forum survey (5-point Likert scale)	T1 (immediately post-forum)
	Barriers and facilitators to engagement and community impact	Focus groups and brief qualitative interviews with participants and CAB members	Post-intervention
Implementation acceptability and appropriateness	Perceived acceptability	AIM, 4 items (5-point Likert)	T1
	Perceived appropriateness	IAM, 4 items (5-point Likert)	T1
	Perceived feasibility (implementation practicality)	FIM, 4 items (5-point Likert)	T1
Exploratory outcomes
Theory-based determinants of screening intention	Perceived threat, perceived efficacy and discriminating value	RBDS grounded in the EPPM	T0–T3
Screening behaviour	Mammography scheduling and completion	Self-reported screening status with optional verification: mammography scheduled by 3 months (T3)	T3 (all participants)
Trust in medical researchers	Trust in medical research and literacy	4-item Trust in Medical Researchers Scale	T0–T3
Research readiness and participation	Research interest and readiness to engage in observational studies	Navigator-administered module: (1) interest item (yes/maybe/no), (2) readiness ruler (0–10) and (3) permission to contact	T1–T3

Completion outcomes will be interpreted in the context of documented mammography scheduling and CRC navigation activity, recognising potential influences of clinic capacity and mobile mammography availability.

AIM, acceptability of intervention measure; CAB, community advisory board; CRC, Clinical Research Coordinator; EPPM, Extended Parallel Process Model; FIM, feasibility of intervention measure; IAM, intervention appropriateness measure; RBDS, Risk Behaviour Diagnosis Scale; T0, baseline (pre-forum); T1, immediately post-forum; T2, 1-month follow-up (call); T3, 3-month follow-up (call); WeCARE, Women’s Engagement for Cancer Awareness, Resources and Education.

Participant satisfaction

Participant satisfaction will be measured using a structured survey, T1. Success is defined as ≥75% of participants rating the experience ≥4 on a 5-point Likert scale. This benchmark aligns with feasibility standards in cancer prevention pilots (70%–80% positive ratings) and reflects whether the culturally tailored forums meet community expectations and foster engagement.

Implementation acceptability and appropriateness

Perceived acceptability, appropriateness and feasibility of the WeCARE intervention will be assessed immediately post-forum (T1) using the validated acceptability of intervention measure (AIM), intervention appropriateness measure (IAM) and feasibility of intervention measure (FIM). Each instrument includes four items rated on a 5-point Likert scale (1=strongly disagree to 5=strongly agree). Mean scores≥4 will indicate satisfactory levels of acceptability, appropriateness and perceived feasibility, consistent with implementation science conventions. The brevity and psychometric validity of these scales make them suitable for community-based feasibility trials, emphasising early implementation readiness.

Theory-based determinants of screening intention (EPPM/RBDS)

Theory-based mediators will be assessed with the RBDS, grounded in the EPPM, at baseline and follow-ups (T0–T3).

Screening intention and behaviour

Breast cancer screening intention and behaviour will be assessed over time (T0–T3) using the behavioural intention subscale of the RBDS. Verification will be optional and used only to evaluate the feasibility of data collection. Screening and intention measures will be analysed descriptively to explore data completeness and to generate preliminary signals for future hypothesis testing.

Trust in medical researchers

Trust in research will be measured using the validated 4-item Trust in Medical Researchers Scale⁴⁴ at T0–T3. Analyses will summarise descriptive distributions and CIs to examine the feasibility of collecting these data and to inform refinement of trust measures for future studies.

Research readiness and participation

Indicators of research interest will be assessed using brief items that capture immediate willingness to learn about research, including a binary indicator (‘Would you like information about a research study that matches your health interests?’ with responses yes, maybe/not sure or no) and a 0–10 readiness ruler (‘How ready are you to talk with a team member about joining a study?’). These items will be administered at T1, T2 and T3. Changes in readiness ratings and interest proportions will be summarised descriptively, and navigator logs will record any subsequent enrolment in observational research. Frequencies and trends will be interpreted qualitatively to guide adaptation of research-readiness messaging in subsequent trials.

Qualitative data are essential to developing a nuanced understanding of engagement perceptions, barriers and facilitators related to this project. Focus groups will be conducted with approximately 6–8 participants and a separate group of CAB members and navigators. The objectives are to (1) characterise perceived acceptability, relevance and impact of the intervention; (2) identify barriers and facilitators influencing screening engagement and research participation readiness and (3) assess community capacity-building outcomes, including gains in research knowledge, communication skills, outreach confidence and partnership development. Sessions will be facilitated by trained moderators using a semistructured discussion guide developed with CAB input. Discussions will last approximately 60–90 min. The interview guide will be developed with CAB feedback.

Data analysis plan

Analyses will be primarily descriptive and benchmark-driven, consistent with a single-arm feasibility design. Recruitment, reach, retention, satisfaction and AIM/IAM/FIM scores will be summarised as proportions or means with 95% CIs and compared against predefined feasibility criteria. Exploratory outcomes, including RBDS/EPPM constructs, screening intention, trust, readiness and screening behaviours, will be summarised using distributions and within-participant change from T0 to T3 to estimate variability and preliminary signal; T4 (6-month follow-up) completion will be reported descriptively among eligible participants. Missing data will be summarised without imputation.

The primary objective of this study is to achieve predefined feasibility thresholds and describe changes in beliefs in healthcare and research over time, and thus, it was not designed to achieve a specific statistical power for an a priori meaningful effect size.

All focus group discussions will be audio-recorded, transcribed verbatim and analysed using a thematic analysis approach.⁴⁵ Two trained coders will independently review transcripts and develop an initial codebook combining inductive insights and deductive categories informed by the study’s conceptual framework. NVivo (or comparable software) will be used to manage data.

Sustainability

As part of sustainability planning,^{46 47} at least two community champions will receive formal training in storytelling and health communication, enabling them to continue leading outreach and advocacy activities beyond the project period. The community champions will be allowed to conduct some of the follow-up calls under the supervision of the CRC, which could enhance sustainability beyond research funding. Lessons learnt from this initiative will inform the design of a larger comparative effectiveness clinical trial and support institutionalisation of the forum and CAB model within WWWP and MCHS community engagement infrastructures.

To ensure shared governance and equitable power distribution consistent with CBPR principles, CAB members and community champions will partner with the WWWP and the MCHS Community Engagement team to co-lead decision-making processes for future community health forums. This structure promotes bidirectional influence by allowing community representatives to shape priorities, resource allocation and dissemination strategies.^{28 48}

Ethics and dissemination

This study was reviewed and approved by the Mayo Clinic Institutional Review Board (IRB #25–008934). All participants will provide informed consent prior to participation, and procedures are designed to minimise risk and protect confidentiality. Community engagement activities, including the co-development of forum content and scripts with the CAB, are intended to ensure cultural sensitivity and mitigate potential stigma.

Participant safety will be safeguarded by trained CRCs, who will use standardised scripts approved by CAB and the investigative team and referral pathways to address any emotional distress, abnormal screening results or unmet social needs (eg, transportation, childcare or financial barriers). Data will be stored securely in REDCap, accessible only to authorised study personnel, and curated in accordance with Mayo Clinic policies and National Institute of Health data-sharing guidelines. Results will be disseminated through peer-reviewed publications, conference presentations and community reports shared with participants, the CAB and local stakeholders. De-identified datasets may be deposited in an appropriate research repository consistent with Mayo Clinic policy and funder requirements.