A Randomized Controlled Trial of the Implementation of BREASTChoice , a Multilevel Breast Reconstruction Decision Support Tool With Personalized Risk Prediction.

OBJECTIVE: To implement the BREASTChoice decision tool into the electronic health record and evaluate its effectiveness. BACKGROUND: BREASTChoice , is a multilevel decision tool that: 1) educates patients about breast reconstruction; 2) estimates personalized risk of complications; 3) clarifies patient preferences; and 4) informs clinicians about patients' risk and preferences. METHODS: A multisite randomized controlled trial enrolled adult women with stage 0-III breast malignancy undergoing mastectomy. Participants were randomized to BREASTChoice or a control website. A survey assessed knowledge, preferences, decisional conflict, shared decision-making, preferred treatment, and usability. We conducted intent-to-treat (ITT), per-protocol (PP) analyses (those randomized to BREASTChoice who accessed the tool), and stratified analyses. RESULTS: 23/25 eligible clinicians enrolled. 369/761 (48%) contacted patients enrolled and were randomized. Patients' average age was 51 years; 15% were older than 65. BREASTChoice participants had higher knowledge than control participants (ITT: mean 70.6 vs. 67.4, P =0.08; PP: mean 71.4 vs. 67.4, P =0.03), especially when stratified by site (ITT: P =0.04, PP: P =0.01), age (ITT: P =0.04, PP: P =0.02), and race (ITT: P =0.04, PP: P =0.01). BREASTChoice did not improve decisional conflict, match between preferences and treatment, or shared decision-making. In PP analyses, fewer high-risk patients using BREASTChoice chose reconstruction. BREASTChoice had high usability. CONCLUSIONS: BREASTChoice is a novel decision tool incorporating risk prediction, patient education, and clinician engagement. Patients using BREASTChoice had higher knowledge; older adults and those from racially minoritized backgrounds especially benefitted. There was no impact on other decision outcomes. Future studies should overcome implementation barriers and specifically examine decision outcomes among high-risk patients.

Implementing shared decision making for early-stage breast cancer treatment using a coproduction learning collaborative: the SHAIR Collaborative protocol.

BACKGROUND: Shared decision making (SDM) in breast cancer care improves outcomes, but it is not routinely implemented. Results from the What Matters Most trial demonstrated that early-stage breast cancer surgery conversation aids, when used by surgeons after brief training, improved SDM and patient-reported outcomes. Trial surgeons and patients both encouraged using the conversation aids in routine care. We will develop and evaluate an online learning collaborative, called the SHared decision making Adoption Implementation Resource (SHAIR) Collaborative, to promote early-stage breast cancer surgery SDM by implementing the conversation aids into routine preoperative care. Learning collaboratives are known to be effective for quality improvement in clinical care, but no breast cancer learning collaborative currently exists. Our specific aims are to (1) provide the SHAIR Collaborative resources to clinical sites to use with eligible patients, (2) examine the relationship between the use of the SHAIR Collaborative resources and patient reach, and (3) promote the emergence of a sustained learning collaborative in this clinical field, building on a partnership with the American Society of Breast Surgeons (ASBrS). METHODS: We will conduct a two-phased implementation project: phase 1 pilot at five sites and phase 2 scale up at up to an additional 32 clinical sites across North America. The SHAIR Collaborative online platform will offer free access to conversation aids, training videos, electronic health record and patient portal integration guidance, a feedback dashboard, webinars, support center, and forum. We will use RE-AIM for data collection and evaluation. Our primary outcome is patient reach. Secondary data will include (1) patient-reported data from an optional, anonymous online survey, (2) number of active sites and interviews with site champions, (3) Normalization MeAsure Development questionnaire data from phase 1 sites, adaptations data utilizing the Framework for Reporting Adaptations and Modifications-Extended/-Implementation Strategies, and tracking implementation facilitating factors, and (4) progress on sustainability strategy and plans with ASBrS. DISCUSSION: The SHAIR Collaborative will reach early-stage breast cancer patients across North America, evaluate patient-reported outcomes, engage up to 37 active sites, and potentially inform engagement factors affecting implementation success and may be sustained by ASBrS.

Construct validation of the Research Engagement Survey Tool (REST).

BACKGROUND: The Research Engagement Survey Tool (REST) was developed to examine the level of partner (e.g., patients, caregivers, advocates, clinicians, community members) engagement in research studies. The REST is aligned with eight engagement principles based on the literature and consensus reached through a five round Delphi process. Each of the engagement principles has three-five corresponding items that are assessed on two Likert type scales quantity (how often: never, rarely, sometimes, often, always, not applicable) and quality (how well: poor, fair, good, very good, excellent, not applicable). We conducted a comprehensive validation of the REST. Despite the importance of partner engagement in research, currently no gold standard measure exists. METHODS: Multiple strategies were employed to validate the REST. Here, we examine the internal consistency of items for each of the eight engagement principles. In addition, we examine the convergent validity of the comprehensive (32-item) REST with other measures (e.g., medical mistrust, Community Engagement in Research Index, Partnership Self-Assessment Tool, Wilder collaboration inventory, Partnership Assessment In community-based Research). We propose two scoring approaches for the REST; one aligned with the engagement principles and the other aligned with levels of community engagement: (1) outreach and education, (2) consultation, (3) cooperation, (4) collaboration, and (5) partnership. RESULTS: The REST has strong internal consistency (Cronbach's alpha > 0.75) for each of the eight engagement principals measured on both scales (quality and quantity). The REST had negligible (e.g., medical mistrust, community engagement in research index), low (e.g., Partnership Assessment In community-based Research, Partnership Self-Assessment Tool- benefits scale), and moderate (e.g., Wilder collaboration inventory, Partnership Self-Assessment Tool- synergy scale) statistically significant correlations with other measures based on the Spearman rank correlation coefficient. These results suggest the REST is measuring something similar and correlated to the existing measures, but it captures a different construct (perceived research engagement). CONCLUSIONS: The REST is a valid and reliable tool to assess research engagement of community health stakeholders in the research process. Valid tools to assess research engagement are necessary to examine the impact of engagement on the scientific process and scientific discovery and move the field of stakeholder engagement from best practices and lessons learned to evidence-based approaches based on empirical data.

Researchers often conduct studies with partners (e.g., patients, caregivers, advocates, clinicians, community members) who also have an interest in the research topic. Depending on the research study the level of partner engagement in the research process may be high or low. Partners may be involved from the beginning including determining what topic to study and what questions the study should examine. They may suggest who should be included in the study, the geographic area of focus, and the outcome measures to be examined. In addition, they may help recruit study participants, interpret study results, and plan for how to share the results with those that need to know. No standard way exists to find out how involved a partner has been in a study from the partner's perspective. Here we develop and validate survey questions to measure the level of partner engagement in research studies. We looked at existing survey questions used to measure similar topics to make sure that a person who takes the survey gets consistent scores. We tested the survey with community health stakeholders (e.g., patients, caregivers, advocates, clinicians, community members) who are research partners for studies at universities across the United States. Over 2 years, the partners took different versions of the survey online four times. We used the data we collected from each survey to revise the questions and make sure that it measures partner involvement accurately and reliably. The Research Engagement Survey Tool (REST) has 32 questions to examine eight engagement principles on two scales: quantity (how much) and quality (how well). The REST is a valid and reliable tool to examine partner engagement in research.

What matters most: Randomized controlled trial of breast cancer surgery conversation aids across socioeconomic strata.

BACKGROUND: Women of lower socioeconomic status (SES) with early-stage breast cancer are more likely to report poorer physician-patient communication, lower satisfaction with surgery, lower involvement in decision making, and higher decision regret compared to women of higher SES. The objective of this study was to understand how to support women across socioeconomic strata in making breast cancer surgery choices. METHODS: We conducted a 3-arm (Option Grid, Picture Option Grid, and usual care), multisite, randomized controlled superiority trial with surgeon-level randomization. The Option Grid (text only) and Picture Option Grid (pictures plus text) conversation aids were evidence-based summaries of available breast cancer surgery options on paper. Decision quality (primary outcome), treatment choice, treatment intention, shared decision making (SDM), anxiety, quality of life, decision regret, and coordination of care were measured from T0 (pre-consultation) to T5 (1-year after surgery. RESULTS: Sixteen surgeons saw 571 of 622 consented patients. Patients in the Picture Option Grid arm (n = 248) had higher knowledge (immediately after the visit [T2] and 1 week after surgery or within 2 weeks of the first postoperative visit [T3]), an improved decision process (T2 and T3), lower decision regret (T3), and more SDM (observed and self-reported) compared to usual care (n = 257). Patients in the Option Grid arm (n = 66) had higher decision process scores (T2 and T3), better coordination of care (12 weeks after surgery or within 2 weeks of the second postoperative visit [T4]), and more observed SDM (during the surgical visit [T1]) compared to usual care arm. Subgroup analyses suggested that the Picture Option Grid had more impact among women of lower SES and health literacy. Neither intervention affected concordance, treatment choice, or anxiety. CONCLUSIONS: Paper-based conversation aids improved key outcomes over usual care. The Picture Option Grid had more impact among disadvantaged patients. LAY SUMMARY: The objective of this study was to understand how to help women with lower incomes or less formal education to make breast cancer surgery choices. Compared with usual care, a conversation aid with pictures and text led to higher knowledge. It improved the decision process and shared decision making (SDM) and lowered decision regret. A text-only conversation aid led to an improved decision process, more coordinated care, and higher SDM compared to usual care. The conversation aid with pictures was more helpful for women with lower income or less formal education. Conversation aids with pictures and text helped women make better breast cancer surgery choices.

Examining peer support and survivorship for African American women with breast cancer.

OBJECTIVE: More than 3.5 million female breast cancer (BrCa) survivors live in the United States, and the number continues to grow. Health status and quality of life among survivors are variable, and African American (AA) survivors suffer disproportionately from BrCa morbidity and mortality. Emerging evidence suggests that peer support is an effective strategy to promote positive survivorship outcomes for AA BrCa survivors. This study aimed to explore the role of peer support in the BrCa experiences of AA survivors. METHODS: Working collaboratively with The Breakfast Club, Inc. (BCI), a community-based BrCa peer support organization, we conducted a quasiexperiment to compare the BrCa experiences of AA survivors. We conducted in-depth interviews with two survivor groups (N = 12 per group), categorized according to receiving peer support during their BrCa experiences. RESULTS: Survivors who received peer support reported greater access to and utilization of alternative support sources, more capacity to process BrCa-related stress, and improved quality of life and adjustment to life as BrCa survivors compared with those who did not receive peer support. CONCLUSIONS: Peer relationships provide consistent, quality social support. Consistent peer support helps survivors cope with the continued stress of BrCa, with implications for psychosocial health and quality of life. Findings expand our current understanding of peer support and may enable public health and clinical practitioners to better recognize and intervene with those for whom additional support services are needed.

Adapting the Breast Cancer Surgery Decision Quality Instrument for Lower Socioeconomic Status: Improving Readability, Acceptability, and Relevance.

Introduction. Breast cancer is the second most common malignancy in women. The Decision Quality Instrument (DQI) measures the extent to which patients are informed and involved in breast surgery decisions and receive treatment that aligns with their preferences. There are limited data on the performance of the DQI in women of lower socioeconomic status (SES). Our aims were to 1) examine (and if necessary adapt) the readability, usability, and acceptability of the DQI and 2) explore whether it captures factors important to breast cancer surgery decisions among women of lower SES (relevance). Methods. We conducted semistructured cognitive interviews with women of lower SES (based on insurance status, income, and education) who had completed early-stage breast cancer treatments at three cancer centers. We used a two-step thematic analysis with dual independent coding. The study team (including Patient Partners and a Community Advisory Board) reviewed and refined suggested changes. The revised DQI was presented in two focus groups of breast cancer survivors. Results. We conducted 39 interviews. Participants found most parts of the DQI to be helpful and easy to understand. We made the following suggested changes: 1) added a glossary of key terms, 2) added two answer choices and an open text question in the goals and concerns subscale, 3) reworded the treatment intention question, and 4) revised the knowledge subscale instructions since several women disliked the wording and were unsure of what was expected. Discussion. The readability, usability, acceptability, and relevance of a measure that was primarily developed and validated in women of higher SES required adaptation for optimal use by women of lower SES. Further research will test these adaptations in lower SES populations.

What matters most: protocol for a randomized controlled trial of breast cancer surgery encounter decision aids across socioeconomic strata.

BACKGROUND: Breast cancer is the most commonly diagnosed malignancy in women. Mastectomy and breast-conserving surgery (BCS) have equivalent survival for early stage breast cancer. However, each surgery has different benefits and harms that women may value differently. Women of lower socioeconomic status (SES) diagnosed with early stage breast cancer are more likely to experience poorer doctor-patient communication, lower satisfaction with surgery and decision-making, and higher decision regret compared to women of higher SES. They often play a more passive role in decision-making and are less likely to undergo BCS. Our aim is to understand how best to support women of lower SES in making decisions about early stage breast cancer treatments and to reduce disparities in decision quality across socioeconomic strata. METHODS: We will conduct a three-arm, multi-site randomized controlled superiority trial with stratification by SES and clinician-level randomization. At four large cancer centers in the United States, 1100 patients (half higher SES and half lower SES) will be randomized to: (1) Option Grid, (2) Picture Option Grid, or (3) usual care. Interviews, field-notes, and observations will be used to explore strategies that promote the interventions' sustained use and dissemination. Community-Based Participatory Research will be used throughout. We will include women aged at least 18 years of age with a confirmed diagnosis of early stage breast cancer (I to IIIA) from both higher and lower SES, provided they speak English, Spanish, or Mandarin Chinese. Our primary outcome measure is the 16-item validated Decision Quality Instrument. We will use a regression framework, mediation analyses, and multiple informants analysis. Heterogeneity of treatment effects analyses for SES, age, ethnicity, race, literacy, language, and study site will be performed. DISCUSSION: Currently, women of lower SES are more likely to make treatment decisions based on incomplete or uninformed preferences, potentially leading to poorer decision quality, quality of life, and decision regret. This study hopes to identify solutions that effectively improve patient-centered care across socioeconomic strata and reduce disparities in decision and care quality. TRIAL REGISTRATION: NCT03136367 at ClinicalTrials.gov Protocol version: Manuscript based on study protocol version 2.2, 7 November 2017.

A Community-Based Partnership to Successfully Implement and Maintain a Breast Health Navigation Program.

Breast cancer screening combined with follow-up and treatment reduces breast cancer mortality. However, in the study clinic, only 12 % of eligible women ≥40 years received a mammogram in the previous year. The objective of this project was to implement patient navigation, in our partner health clinic to (1) identify women overdue for a mammogram; and (2) increase mammography utilization in this population over a 2-year period. Women overdue for a mammogram were identified. One patient navigator made navigation attempts over a 2-year period (2009-2011). Navigation included working around systems- and individual-level barriers to receive a mammogram as well as the appropriate follow-up post screening. Women were contacted up to three times to initiate navigation. The proportion of women navigated and who received a mammogram during the study period were compared to women who did not receive a mammogram using Chi square tests for categorical variables and t tests for continuous variables with an α = 0.05. Barriers to previous mammography were also assessed. With 94.8 % of eligible women navigated and 94 % of these women completing mammography, the implementation project reached 89 % of the target population. This project was a successful implementation of an evidence-based patient navigation program that continues to provide significant impact in a high-need area. Cost was the most commonly cite barrier to mammography. Increasing awareness of resources in the community for mammography and follow-up care remains a necessary adjunct to removing structural and financial barriers to accessing preventive services.

A Community Coalition to Address Cancer Disparities: Transitions, Successes and Challenges.

Community-based participatory (CBP) strategies are considered important to efforts to eliminate disparities. This paper outlines how the Program for the Elimination of Cancer Disparities (PECaD) uses CBP strategies as a part of a long-term cancer education, prevention, and control strategy in an urban community. Community partnerships have proved to be vital resources to inform PECaD's agenda and the research practice of academic partners. We begin with a description of PECaD governance and partnership structures. The paper then describes programmatic activities and successes, including efforts to monitor clinical trials, deployment of mammography resources, anti-smoking, and prostate and colorectal cancer (CRC) screening education. The influence of changes in funding priorities, preventive screening policy, and community partner development on the partnership process over time is discussed. PECaD community partners have grown and expanded beyond the Program's mission and developed additional partnerships, resulting in a reevaluation of relationships. The impact of these external and internal changes and pressures on the partnerships are noted. The evolution of the evaluation process and what it has revealed about needed improvements in PECaD activities and operations is presented. A summary of the lessons learned and their implications for CBP practice are provided.

Barriers to mammography among inadequately screened women.

Mammography use has increased over the past 20 years, yet more than 30% of women remain inadequately screened. Structural barriers can deter individuals from screening, however, cognitive, emotional, and communication barriers may also prevent mammography use. This study sought to identify the impact of number and type of barriers on mammography screening status, and to examine whether number and type of barriers are different for never-screened and off-schedule women. A total of 182 women aged 40 years or older completed a computer kiosk facilitated survey as part of a larger patient navigator intervention. Logistic regression analysis indicated that breast cancer knowledge predicted whether a woman had ever had a mammogram (odds ratio [OR] = 1.04, 95% confidence interval [CI] = 1.02-1.06, p = .0003), while the number of emotional, structural, and communication barriers predicted whether a woman was on-schedule for mammograms (OR = 0.79, 95% CI = 0.65-0.95, p = .0127). The results suggest that to increase the use of mammography at recommended regular intervals, interventions should be tailored toward current screening status.

A method for achieving reciprocity of funding in community-based participatory research.

BACKGROUND: The St. Louis Komen Project was conceived to address disparities in breast cancer treatment and outcomes between African-American and White women in St. Louis, Missouri. Our goal was to apportion tasks and funding through a process to which all researcher partners had input and to which all could agree, thus eliminating institutionalized inequalities. METHODS: This paper describes the collaborative process and resulting division of responsibilities, determination of costs, and ultimate allocation of funds and resources, as well as the documentation employed to achieve funding reciprocity and equal accountability. RESULTS: Both communication and documentation are critical. Although the Memoranda of Understanding employed are not a panacea, they codify roles and expectations and promote trust. The process of developing financial transparency set the tone for subsequent steps in the research process. CONCLUSIONS: The exhaustive planning process and project-specific procedures developed by its partners have helped the project foster reciprocity, facilitate participation, and equitably distribute resources.

An institutional strategy to increase minority recruitment to therapeutic trials.

PURPOSE: Participation in therapeutic clinical trials rarely reflects the race and ethnic composition of the patient population. To meet National Institutes of Health-mandated goals, strategies to increase participation are required. We present a framework for institutional enhancement of minority clinical trial accrual. METHODS: We implemented structural changes on four levels to induce and sustain minority accrual to clinical trials: (1) leadership support; (2) center-wide policy change; (3) infrastructural process control, data analysis, and reporting; and (4) follow-up with clinical investigators. A Protocol Review and Monitoring Committee reviews studies and monitors accrual, and the Program for the Elimination Cancer Disparities leads efforts for proportional accrual, supporting the system through data tracking, Web tools, and feedback to investigators. RESULTS: Following implementation in 2005, minority accrual to therapeutic trials increased from 12.0 % in 2005 to 14.0 % in 2010. The "rolling average" minority cancer incidence at the institution during this timeframe was 17.5 %. In addition to therapeutic trial accrual rates, we note significant increase in the number of minorities participating in all trials (therapeutic and nontherapeutic) from 2005 to 2010 (346-552, 60 % increase, p < 0.05) compared to a 52 % increase for Caucasians. CONCLUSIONS: Implementing a system to aid investigators in planning and establishing targets for accrual, while requiring this component as a part of annual protocol review and monitoring of accrual, offers a successful strategy that can be replicated in other cancer centers, an approach that may extend to other clinical and translational research centers.