Patient Engagement in Cancer Research: Environmental Scan Report

Conducted by the Hutchinson Institute for Cancer Outcomes Research (HICOR) at Fred Hutchinson Cancer Research Center for the PCORI Eugene Washington Engagement

Award Project, “Enhancing Patient Engagement in Community-Based Outcomes Research” (8623-FHCRC)

August 8, 2018

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Table of Contents

Introduction 2

Approach Internal Scan Methods External Scan Methods

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Results Internal Scan Results External Scan Results

Cancer Research Centers and Research-Related Organizations Oncology Studies Common Goals of Patient Engagement Tools, Best Practices and Challenges

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Limitations

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Conclusions

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Future Directions

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References

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Appendix A: Patient Engagement at Cancer Research Centers

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Appendix B: Stakeholder Engagement at Cancer Research Centers

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Appendix C: Patient Engagement Resources and Tools

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Introduction

Hutchinson Institute for Cancer Outcomes Research (HICOR): Research Portfolio

Located at the Fred Hutchinson Cancer Research Center in Seattle, the Hutchinson Institute for Cancer Outcomes Research (HICOR) is a program led by Dr. Scott Ramsey which designs and implements national clinical trials, collaborative community projects, and innovative research studies to reduce the human and economic burden of cancer. Cancer care delivery research (CCDR) is a primary focus of the HICOR portfolio. As defined by the National Cancer Institute (NCI), “cancer care delivery research is a multidisciplinary science that examines how patient and clinician behavior, organizational structures, health technologies, and financing approaches influence the availability, quality, cost and outcomes of cancer care.”1 CCDR utilizes a variety of research methods including comparative effectiveness research (CER), care delivery interventions, and pragmatic trials.

HICOR’s Stakeholder Engagement

HICOR engages a broad network of stakeholders in Washington state including 32 patient partners and 75 stakeholder partners (i.e. cancer care providers, payers/health insurance providers, guideline experts, non-profit representatives, government representatives, researchers/academics) through HICOR’s Value in Cancer Care Initiative. These community members provide feedback on research prioritization and the design and implementation of community-based studies that test interventions aimed at improving cancer care delivery. Patient partners comprise a small subgroup within this network. HICOR aims to strengthen and formalize its patient engagement program through a two-year capacity building project funded by the Patient-Centered Outcomes Research Institute (PCORI) Eugene Washington Engagement Award.

The PCORI Eugene Washington Engagement Award Project

The goal of this project is to create clear processes and communication pathways to integrate patient partners into HICOR’s CCDR portfolio, including study planning, implementation and dissemination. The first phase of the project is a needs assessment, which includes: 1) an environmental scan of peer and gray literature (i.e., unpublished literature) describing cancer research patient engagement models, enablers and best practices, 2) patient partner focus groups to understand patient research priorities in CCDR, and 3) a stakeholder survey to understand HICOR faculty and other stakeholder perspectives on patient engagement. Based on the results from the needs assessment, we will develop a patient engagement plan, which outlines all systems, processes and procedures for sustainable patient engagement.

Patient Advisory Council (PAC)

This project is guided by a Patient Advisory Council (PAC) consisting of five patient partners from the greater Seattle area who identify as patient advocates, survivors, and caregivers in the community. Patients were invited to serve on the PAC due to their involvement in either HICOR’s Value in Cancer Care Initiative or HICOR CCDR studies, their demonstrated understanding of HICOR’s research portfolio, and the diversity and depth of experiences they bring to the project. PAC members provide guidance and oversight of all project activities and convene regularly to discuss project updates and key deliverables.

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Approach I. Overview The purpose of the environmental scan was to review existing methods, models, activities, best practices, and opportunities for patient engagement in CCDR. The following outline illustrates the broad processes and methods that were used to conduct the scan. These are described in more detail in the subsequent sections.

A. Internal Scan

a. Define internal scan focus question b. Review and thematically categorize existing and planned HICOR research portfolio c. Solicit Patient Advisory Committee feedback on HICOR research portfolio summary

B. External Scan

a. Define external scan focus question b. Conduct an online search targeting cancer research centers and other organizations involved in cancer

research, including those suggested by the PAC, for information about existing patient engagement practices

c. Review published literature (i.e. academic/scientific, gray literature) to identify oncology research studies that incorporate patient engagement, mechanisms of patient engagement, and best practice and tools for patient engagement in cancer research, focusing on CCDR whenever possible

II. Internal Scan Methods

A. Define Internal Scan Focus Question.

The internal scan focus question, which corresponds to the overarching goal of this project, is: How do we best integrate patients’ research priorities and interests with HICOR’s research portfolio, faculty expertise and available resources? To guide our scan, we separated this “big picture” question into three specific questions:

a. What are HICOR’s CCDR priorities? b. What are patient priorities and interests pertaining to CCDR? c. What are the existing tools and best practices for integrating patient engagement into CCDR?

B. Review and thematically categorize existing and planned HICOR research portfolio and priorities through a three-step process:

a. We generated a list of all HICOR active research studies and projects in development. b. We organized this list into thematic categories. For each category, we defined the lay research

question(s) that addressed the topic area. For example, the category of “Clinical Guideline Adherence” was associated with the lay research questions: What is happening in patient care compared to what the guidelines recommend? What is driving the gaps between what guidelines recommend and real-world patient care?

c. Using the NCI’s CCDR definition, we determined which categories fell under the umbrella of CCDR (N=10). These ten categories were referred to as “HICOR’s CCDR priorities,” and are summarized in Table 1.

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Table 1: HICOR’s CCDR Priorities

HICOR CCDR Priorities and Research Questions

Health Outcomes (Patterns of Care, Screening, Prevention) How do patterns of care, screening and prevention impact patient outcomes? How can we improve outcomes and inform effective interventions aimed at patients, providers and health systems to reduce the burden of cancer? Disparities How do patient care, access to care, and outcomes vary based on patient characteristics (e.g., race, ethnicity, geographic location, socioeconomic status)?

Clinical Guideline Adherence What is happening in patient care compared to what the guidelines recommend? What is driving the gaps between what guidelines recommend and real-world patient care?

Financial Impact of Cancer How do we understand and reduce the economic burden on patients and the health care system?

Cost-effectiveness What do we get for what we pay? What is the relationship between cost and desired outcome? How does the value of existing treatment A compare with new treatment B? What are the benefits of a new treatment, such as fewer side effects, quality of life, and survival?

Clinical Trial Participation What are the barriers to clinical trials participation? Can we design trials that are easier for patients to join?

Precision Medicine What is the impact of tumor genetic testing and emerging targeted therapies on patient care?

Patient-Centered Health Information Technology How can we leverage or build technologies that improve patient experience and outcomes?

Data Transparency and Public Reporting How can public reporting of quality and cost data improve care? What is the best way to share performance metrics and results with the general public (including patient and stakeholder communities)?

Implementation Science What are the best ways to get effective treatments and technologies into the community?

C. Solicit Patient Advisory Committee Feedback on HICOR research priorities We convened the PAC to solicit their feedback on HICOR research priorities including whether there are gaps in our portfolio, and to request guidance more generally on which CCDR topics are of greatest interest and relevance to patients.

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III. External Scan Methods

A. Define External Scan Focus Question As a starting point for our external scan, we defined our focus question as: What are the best practices for integrating patient engagement into cancer care delivery research (CCDR)? During our initial search, we quickly found that this focus question was too narrow in scope to render substantial results. Thus, we expanded our focus question to: What are the best practices for integrating patient engagement into cancer research? B. Online Search Targeting Cancer Research Centers and Other Organizations Involved in Cancer

Research

We employed three search methods to identify cancer research centers around the country of comparable size and scope to the Fred Hutchinson Cancer Research Center:

a. Google b. National Institutes of Health Project RePORTER c. The online portfolio of the Patient-Centered Outcomes Research Institute (PCORI)

We also included PAC suggestions of organizations that incorporate patient engagement, including: Society for Participatory Medicine, LUNGevity, National Breast Cancer Coalition (Project LEAD), The Prostate NET (CADRE), and the Alamo Breast Cancer Foundation/San Antonio Breast Cancer Symposium. Finally, we conducted a Google search for additional organizations using the search terms, “drug company” “cancer” “patient advisory” “patient advocate” “patient ambassador.”

Among the research centers and organizations identified, we scanned for information available online regarding patient engagement practices and any existing oncology studies that had a patient engagement component.

C. Comprehensive literature review We conducted an internet search for published literature using these platforms:

a. PubMed b. Google Scholar c. Google d. National Institutes for Health (NIH) Project RePORTER e. Patient-Centered Outcomes Research (PCORI) Portfolio f. National Cancer Institute (NCI) Community Oncology Research Program (NCORP) “Find a Study”

Our primary search terms were “patient engagement” “cancer” and “research.” In addition, we incorporated “best practices” “tools” and “resources” into several searches. Data were organized using tables in Microsoft Word, and publications and citations were archived using EndNote. Regular searches were conducted over a three-week period. Project staff analyzed the scanning output to identify key themes or categories related to our focus question, with guidance from project investigators.

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Results A. Internal Scan Results The internal scan provided valuable information about the alignment of HICOR research portfolio with patient priorities and identified gaps in the portfolio. According to PAC members, HICOR’s 10 areas of CCDR were relevant from the patient perspective; however, the following research areas stood out as being of greatest interest to the PAC and were discussed in depth during the meeting:

• Clinical Trial Participation • Financial Impact of Cancer • Patient-centered Health Information Technology • Disparities • Screening, particularly barriers to access, equity, outcomes, and knowledge/awareness

There was consensus among the PAC and project team that the topic of “Disparities” permeates all categories and is important to consider in all contexts of CCDR. “Disparities” remains a separate category to highlight its importance while recognizing it as a cross-cutting theme. The PAC identified the following gaps and opportunities for further research:

• Health communication: the role and impact of social media and online patient networks on CCDR • Financial impact of cancer: access to disability benefits • Disparities: specific categories such as patient-centered health information technology, clinical trial

participation and screening • Patient engagement: how to engage patients in research, particularly those representing marginalized

identities or disadvantaged communities • Impact of marijuana use on outcomes and the patient experience

PAC members emphasized the influence of social media on cancer patients’ experiences, knowledge and communication. Several members noted that a wealth of information is exchanged on social media, especially through Facebook patient groups (open and closed groups) and Twitter, and that social media can help patients find clinical trials, increase education, and facilitate partnerships with organizations. One PAC member referenced a recent National Cancer Institute (NCI) Workshop in Washington, DC that highlighted the lack of data on the impact of social media on cancer patients. In general, the ways that patients obtain and share information about cancer care online is an understudied research area with significant potential to yield insights relevant to CCDR. To acknowledge this, the PAC and project team decided to add the category of “Health Communication” to the list of HICOR’s CCDR priorities (Table 2). One PAC member also suggested that this category could encompass real-world problems about cancer communication, such as language about “cures” and the danger of giving false hope.

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Table 2: HICOR’s CCDR Priorities – Updated following PAC guidance

HICOR’s CCDR Priorities PAC input Highlighted as a top PAC priority

Health Outcomes (Patterns of Care, Screening, Prevention)

Disparities Should be studied as a factor in other areas of CCDR, as disparities exist across the healthcare delivery continuum.

Clinical Guideline Adherence Screening is a particular area of interest. Providers without oncology-specific training may not be well informed of existing cancer care guidelines.

Financial Impact of Cancer Gaps or loss of insurance coverage an issue. Loss of employment (for patients or caregivers) and disability play a large role in financial hardship.

Cost-effectiveness

Clinical Trial Participation African American men have low participation. Time off work and lack of knowledge of available clinical trials are known barriers. Other barriers are lack of or poor communication between the patient and provider about trial opportunities, especially those not being conducted at the provider’s institution.

Precision Medicine

Patient-Centered Health Information Technology

Data Transparency and Public Reporting

Implementation Science

Health Communication (new category added following PAC guidance)

Suggested by PAC as a new CCDR priority. Emphasis on wealth of information exchanged on social media, especially by Facebook patient groups and on Twitter. Social media platforms help patients access clinical trials, increase health education and facilitate partnerships with organizations. There is not enough research in this area. Noted the existence of a digital divide, with white women most likely to access online resources.

B. Results of External Scan

B1. Cancer Research Centers and Research-Related Organizations that Incorporate Patient and Stakeholder Engagement

We identified 20 cancer research centers and other research-related organizations that incorporate patient or stakeholder engagement. A full list of these cancer research centers and their engagement practices is in Appendix A: Patient Engagement at Cancer Research Centers and Appendix B: Stakeholder Engagement at Cancer Research Centers. Table 3 is a summary of the patient engagement mechanisms, activities and engagement goals identified by the scan.

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Table 3. Common patient engagement mechanisms, goals and activities used by organizations funding or conducting cancer research

Patient engagement mechanism

Number and type of organizations identified in

the search who use this mechanism (n= 20)

Stated patient engagement activities and goals

Specified application in CCDR:

Patient Advocate Committee

1 of 20: Federal cancer research organization/program

• Ensure the concerns of patients are addressed • Ensure patients understand risks and benefits of joining

a clinical trial

Other examples from cancer research, not identified as CCDR:

Specified patient engagement, but no publicly available description of mechanism and/or practices

9 of 20: Cancer research center/program Industry Professional society Foundation

• Optimization of patient engagement in the research • Share patient perspectives • Engage patients in defining research questions and the

scientific process • May be compensated for participation

Patient Advisory Council Patient Research Advocacy Group Patient Advocate Steering Committee

5 of 21: Cancer research center/program Industry Federal funder of cancer research

• “build patient powered research agenda” • “dismantle the wall between researcher and

researched” • Establish protocols for patient engagement in research • Develop and provide training for advocates and

researchers to promote efficient collaboration • Collective identification of research priorities • Identify areas for patient, survivor and caregiver

inclusion in research • Promote inclusion of patient centered research

materials • Contribute to the submission and conduct of grants that

require patient participation • Integrate patients advocates into the development and

evaluation of clinical trials • Optimize patient portal • Develop video series for new patients and their families • Worked to reduce financial toxicity

Inclusion of Patient Advocates on existing Advisory Boards

2 of 20: Industry • No information publicly available

Individual patient advocates advise researchers on specific study issues as needed by participating in meetings and reviewing materials

2 of 20: Cancer research center/program

• Ensure scientific objectives lead to improvements in patient care

• Promote effective interaction and collaboration among investigators, patients

Patient Advisory Program 1 of 20: Cancer research center

• Different types of advisors each with different responsibilities and time commitments

• Attend project meetings, review materials, participate in surveys

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Scientist-Survivor Program 1 of 20: Professional society

• Connect patient advocates with scientific mentors

We did not identify any comparable or “peer” research programs to HICOR that conduct cancer care delivery research (CCDR) and patient or stakeholder engagement. Of the 20 cancer research organizations identified in our scan, only SWOG, a NCI-supported network of cancer research across the U.S., Canada, and beyond, described the use of patient engagement specifically in CCDR. The remaining 19 organizations described patient engagement in cancer research but not CCDR. SWOG utilizes a 17-member Patient Advocate Committee for patient engagement that seeks to ensure the concerns of cancer patients are addressed and that patients understand the risks and benefits of joining a clinical trial.32 SWOG Patient Advocate Committee members serve on research committees, including a Cancer Care Delivery Committee, and play a key role in the SWOG prioritization and approval process for newly proposed studies.

Among the organizations identified by our scan, most described their patient engagement activities and goals but did not provide a publicly available description of the mechanisms of engagement (e.g. committee, focus groups). The most commonly used engagement mechanism across organization type was a formal patient advocate council or committee. 4 of 20 organizations used this approach to conduct their engagement activities.

From these results, we identified the three most common areas of patient engagement activities and focus across all 20 organizations:

1. Development of methodologies for effective patient engagement in cancer research • Establish protocols and frameworks for patient engagement in research • Participate in training to promote efficient collaboration

2. Research priority setting • Identification and ranking of research priorities

3. Providing real-time input on the design and conduct of research activities • Contribute to the submission and conduct of grants that require patient participation • Attend project meetings • Review research materials • Participate in surveys, interviews and focus groups • Inform trial design • Collaborate on core stud decisions • Provide guidance on study activities • Review study findings • Assist with dissemination of results

B2. Oncology Studies that Incorporate Engagement

To focus on stakeholder engagement in cancer care delivery research, we searched the National Cancer Institute (NCI) Community Oncology Research Program (NCORP) database and found six studies that met the “cancer care delivery research” trial type criteria. Only one study – “S1415CD Trial Assessing CSF Prescribing Effectiveness and Risk (TrACER)” – incorporated stakeholder engagement in the study design, specifically through an External Stakeholder Advisory Group (ESAG). HICOR director Dr. Scott Ramsey is the principal investigator on this study, which was funded partially through a Patient-Centered Outcomes Research Institute award (PCS-1402-09988).

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Broadening our search, we looked for examples of patient engagement in oncology studies not limited to CCDR, and we identified 12 relevant articles pertaining to patient engagement in oncology studies (Table 4). Four articles focused solely on patient engagement, and the other eight included patients as part of a multi-stakeholder engagement. None of the studies were conducting CCDR; however many of the studies fell into categories of research that overlap with CCDR including Comparative Effectiveness Research (CER), Patient-Centered Outcomes Research (PCOR), and Health-Related Quality of Life.

Table 4. Patient engagement examples, key learnings and outcomes in cancer research studies, not CCDR-specific

Patient engagement mechanism

Number and type of studies

identified in our search who use this mechanism

(n= 12)

Stakeholder engagement activities and goals

Key engagement learnings, outcomes

Patients are part of an external stakeholder advisory group that includes other types of stakeholders (e.g. clinicians, payers, policy makers)

8 of 12: CER Patient consent process Cancer screening

• Inform trial design • Stakeholder-researcher meetings

with structured discussion process • Research prioritization • Collaborate on core study decisions • Provide guidance on study

activities • Review study findings

• Engagement process resulted in changes made to the trial design

• Challenges included: unclear role expectations, limited opportunities to communicate with investigators, lack of clarity on how stakeholder input was integrated into study design decisions, balancing timely input from stakeholders with pace of research needs

• In-depth, face-to-face deliberation can impact stakeholder priority rankings

• Study in progress, no engagement findings publicly reported

Patient Advisory Committee

1 of 12: CER

• Provide feedback throughout the project

• Assist with dissemination of findings

• Study in progress, no engagement findings publicly reported

Focus groups with diverse stakeholders

1 of 12: Trial participation

• Stakeholders were interviewed to identify barriers and motivators to recruitment during randomized controlled trials

• No engagement findings publicly reported

Online repository of patients and caregivers

1 of 12: urologic oncology

• Research prioritization • Need for varied recruitment strategies to engage a broad representation of patients

• Important to coordinate patient care visits with engagement activities

• Specific methodologies like snowball sampling and translation of engagement materials can improve representation of underrepresented populations

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• Key to effective engagement requires patient involvement as early as possible in the research process

The most common mechanism of engagement, described in 8 of the 12 studies, was an external advisory group in which patients were one of several stakeholder groups convened for the purpose of engaging with a specific oncology study. In general, these stakeholder groups included patients/patient advocates, clinicians, health insurers/payers, policymakers, regulators, health care representatives, and occasionally industry representatives. Other mechanisms used less frequently were a patient advisory committee, focus groups, and an online database of patients and caregivers.

Patient engagement activities were similar to those utilized by the organizations described above and included: development of research questions and causal models, research prioritization and trial design, guidance on study activities, identification of barriers and motivators to recruitment, and assistance with dissemination of study findings.

As reflected in this small number of publications, there is little available information about patient engagement in cancer research. However, there is substantially more information about stakeholder engagement – which may include patients in addition to other individuals like payers and providers – in cancer research.

B3. Common goals of patient engagement in cancer studies and cancer-related organizations

Four common goals of patient engagement emerged from an analysis of the scan results from oncology studies (n=12) together with the patient engagement efforts of organizations involved in cancer research (n=20). They are listed in Figure 1, appearing in order of how frequently they were encountered in the literature.

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Figure 1. Most commonly described goals of patient engagement efforts among identified CCDR and cancer research studies and organizations involved in cancer research

B4. Tools, Best Practices and Challenges of Patient Engagement in Research

Through the comprehensive literature review, we identified reports, presentations and journal articles that featured best practices, recommendations, tools and models for patient engagement in research. The resources were organized into the following categories: general patient engagement in research (N=3), cancer research (N=1), patient-centered outcomes research (N=3), comparative effectiveness research (N=4), health-related quality of life research (N=1), and clinical research (N=1). The full list of resources is featured in Appendix C. None of the resources specifically target patient engagement in cancer care delivery research, yet their recommendations and best practices may be applied to our project and future CCDR research. In all, we identified 30 best practice recommendations for patient engagement. From these, we identified 10 that were described in at least three or more of the source documents (at least 10%). These most commonly encountered best practices are shown below in Table 5.

It is notable that 21 identified best practices were only described by one source, indicating that at least within our sample, there is no strong consensus on how best to practice patient engagement in the context of CCDR or cancer research more broadly. Indeed, one source stated that there was no, “one size fits all” method for successful engagement.22 Research teams must be flexible and existing practices may need to be adapted to the needs of the project, the targeted community, and the individual patients and other members of the research team.

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Table 5. Most commonly reported best practices for patient engagement from the comprehensive literature review

Best Practice Description 1 Engage patient advocates early and often during the research project. 2 Engage patients throughout the life cycle of the project, from topic selection and study

design, through to dissemination. 3 Critical to establish mutual trust between the patient partners and other members of the

research team. 4 Provide appropriate training to patients and researchers about best practice for

engagement and collaboration. Share a common definition for the research, make sure everyone has a thorough understanding of what the research is about.

5 Respect patient privacy. 6 Focus on community engagement. 7 Ensure dedicated and sufficient resources (money and time) for patient and stakeholder

involvement. 8 Select representatives that are similar to the community or population on which the study

results are intended to apply. 9 Clearly define roles, define requirements for stakeholder selection, maintain a transparent

process 10 Make a sincere effort to give back to the community Item 1 found in 6 of 13 scanning hits; Items 2-5 found in 4 of 13 scanning hits; Items 6-10 found in 3 of 13 scanning hits

Many of the best practice documents identified in our search also described challenges and barriers to patient engagement in research. Although we did not set out to identify engagement challenges and barriers as part of our scan, we determined this information could be useful towards the generation of a comprehensive engagement plan for HICOR as it may help us anticipate and construct strategies to address common challenges, as well as help inform the development of our focus questions.

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Table 6. Barriers and challenges to patient engagement in cancer research

Barriers/Challenges Lack of clarity about patient role and expectations on the project Limited opportunities for patients to communicate with investigators Lack of clarity on how stakeholder input impacts decision-making Balancing timely input from stakeholders with the pace of research needs, time constraints Stakeholders rarely have the time of expertise to act as members of the review team and participate in the review process Sustaining engagement may be challenging during lengthy projects Can be difficult to engage hard-to-reach patient populations such as minorities, non-English speakers, low socio-economic status, physical or cognitive impairment Not enough dedicated money, time and resources. Increased cost and time of the project. Impediments to two-way learning Limited evidence base for effective patient engagement practices, and best practices are likely to evolve making it difficult to keep up. Lack of methodological guidance. Reporting of patient engagement practices in the literature is poor. Principal Investigator acceptance and understanding Targeting the right population to engage Ensure what you are asking patients to do is reasonable Conflicts with patients’ work/life schedules Researcher bias when selecting patients Not having sufficient expertise in engagement Tokenistic engagement vs. meaningful engagement Insufficient incentive for patients (no or low compensation) Perceived inequality between patients and researchers Poor communication Patient lack of knowledge or experience in the subject area Some patients do not wish to be engaged despite the approach you take Some patient are angry or distrustful of healthcare providers Lack of institutional support

Limitations This environmental scan has several limitations. First, the lack of available information specific to CCDR forced us to broaden our search to include engagement practices and resources for all types of cancer research. However, CCDR is distinct from other oncology disciplines, most notably treatment trials, with its multidisciplinary examination of how different social, economic, organizational, behavioral and technological systems impact the health and well-being of cancer patients. As such, it is not guaranteed that engagement strategies that work in a treatment or cancer prevention setting would necessarily translate and prove successful in CCDR. Second, the scan does not capture unpublished literature on resources, projects or knowledge about patient engagement in cancer research. Third, we did not incorporate data collection using social media (e.g., Facebook, Twitter), which may have expanded our resource list or information of cancer-related research projects that incorporate engagement.

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Conclusions

The results from this environmental scan demonstrate that although CCDR is a growing field that is gaining recognition as critical to the future of our health care system and patient outcomes, there is limited publicly available information about the design and implementation of patient and multi-stakeholder engagement programs in the field. Despite this major gap in knowledge, we found that numerous organizations and individual research studies are conducting some form of patient or stakeholder engagement, the most common being through a patient advisory program or community advisory board. In addition, institutions beyond traditional research or medical organizations are incorporating patient and stakeholder engagement into cancer-related research, including pharmaceutical companies, academic societies and foundations or nonprofit organizations that partner with research organizations. Although such examples were not specific to CCDR, many of the targeted research areas overlapped or were relevant to cancer care delivery and include those identified as HICOR’s CCDR priorities such as outcomes research and patient participation in clinical trials. As such, we feel it is worthwhile to explore best practices and techniques from this broader knowledge base to inform our efforts to build a patient engagement program tailored to CCDR and HICOR.

Figure 2 summarizes the most commonly used and identified best practices and patient engagement techniques from the scan results and indicates areas of overlap and gaps with HICOR’s current practices. As shown, there is alignment primarily in the types of activities HICOR patient partners are performing for projects. Significant gaps also emerge, most notably in the infrastructure for effective engagement; additional gaps include the lack of a formal, organizational structure for patients and engagement practices, such as frequency and timing of engagement, defined roles and giving back to the target community. This coupled with the lack of CCDR-specific resources in the literature demonstrate that there is significant potential for HICOR to build capacity and infrastructure to facilitates patient engagement.

Figure 2. Areas of alignment (solid lines) and gaps (dashed lines) between HICOR’s current practices and those of the research organizations and studies identified in our scan.

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Future Directions

We intend to update this environmental scan internally as we gain new information about relevant studies, best practices, or models pertaining to patient engagement in research. The information collected and analyzed through this scan will inform our project planning for the PCORI Eugene Washington Engagement Award, specifically the development of questions for our patient focus groups. We will share the scan results with our PAC and discuss with them which parts may be most relevant in the formation of meaningful focus group questions. Information from the scan that may prove useful to such discussions are examples of common barriers and challenges to engagement, patient acceptability and feasibility of implementing different mechanisms of engagement, and patient preference for various engagement activities.

In our patient partner focus groups themselves, we will further investigate patients’ understanding of CCDR using HICOR’s CCDR priorities framework. In addition, we will draw on best practices as we identify gaps in and enhancements to our patient engagement program throughout our systematic needs assessment. Findings from the scan related to engaging hard-to-reach groups may also inform our recruitment strategy for both the focus groups and the final HICOR patient engagement plan.

In sum, this report reinforces that although there is a lack of publicly available knowledge about patient and stakeholder engagement CCDR, there is a growing body of literature on patient engagement in cancer research more broadly, which yields some information about engagement tools, best practices and challenges. These resources could be adapted for use in CCDR studies and research programs. In addition, this report enhances our understanding of the landscape of patient engagement in cancer research and highlights the promising future of patient and stakeholder engagement in cancer care delivery research.

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21. Curtis P, Slaughter-Mason S, Thielke A, et al. PCORI Expert Interviews Project: Final Report. Portland: Center for Evidence-based Policy, Oregon Health and Science University;2012.

22. Domecq JP, Prutsky G, Elraiya T, et al. Patient engagement in research: a systematic review. BMC Health Services Research. 2014;14(89):1-9.

23. Mullins CD. Integrating patients’ voices in study design elements with a focus on hard-to-reach populations. 2012.

24. Greene SM, Brandzel S, Wernli KJ. From Principles to Practice: Real-World Patient and Stakeholder Engagement in Breast Cancer Research. The Permanente Journal. 2018;22:17-232.

25. PCORI. Workshop on Incorporating the Patient Perspective into Patient-Centered Outcomes Research. Patient-Centered Outcomes Research Institute Methodology Committee;2012.

26. PCORI. Draft Methodology Report: ‘Our Questions, Our Decisions: Standards for Patient-centered Outcomes research. 2012.

27. Forsythe LP, Ellis LE, Edmundson L, et al. Patient and Stakeholder Engagement in the PCORI Pilot Projects: Description and Lessons Learned. Journal of General Internal Medicine. 2016;31(1):13-21.

28. Mullins CD, Abdulhalim AM, Lavallee DC. Continuous Patient Engagement in Comparative Effectiveness Research. JAMA. 2012;207(15):1587-1588.

29. Nass P, Levine S, Yancy C. Methods for Involving Patients in Topic Generation for Patient-Centered Comparative Effectiveness Research: An International Perspective. 2012.

30. Institute BR. Patient Engagement Best Practices Resource Document. Patient-Centered Comparative Effectiveness Research Center at Brigham Research Institute2015.

31. Carlos R. Defining a Roadmap for Patient Engagement in Imaging Comparative Effectiveness Research. 2017.

32. Haywood K, Lyddiatt A, Brace-McDonnell SJ, Staniszewska S, Salek S. Establishing the values for patient engagement (PE) in health-related quality of life (HRQoL) research: an international, multiple-stakeholder perspective. Quality of Life Research. 2017;26(6):1393-1404.

33. Sacristán JA, Aguarón A, Avendaño-Solá C, et al. Patient involvement in clinical research: why, when, and how. Patient preference and adherence. 2016;10:631-640.

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Appendix A: Patient Engagement at Cancer Research Centers

Cancer Research Center Patient Engagement

Model

Description of Patient Engagement

Boston Medical Center, Cancer Research at a Safety Net Hospital

Patient Advisory

Council (PAC)

“provide ongoing training and engagement activities designed to dismantle the wall between researcher and researched, in an effort to increase community engagement in cancer research. The PAC will work with cancer center researchers to build a patient powered research agenda whereby cancer survivors and their family members will collectively identify research priority areas, contributing to the overall vision of the cancer center”2

Dana-Farber Cancer Institute, Administrative Advocacy Planning and Communication (AAPC)

Core, Dana-Farber/Harvard Breast

SPORE

Patient Advocates

“Optimizing the engagement of patient advocates in the research and core work of the Breast SPORE is a significant aim of this Core.”3

Fred Hutchinson Cancer Research Center SPORE (Specialized Program of

Research Excellence)

Patient Advocates

Seattle Cancer Consortium Breast SPORE – “Advocates from the local community, including survivors, participate to assure that scientific objectives lead to improvements in patient care. They advise investigators on issues including recruitment strategies and content of participant materials. They participate in meetings and assist with pilot project application review, reminding us that a strong project is one that moves the SPORE toward advancing breast cancer prevention, early detection or treatment to improve breast cancer outcomes. The patient advocates promote effective interaction and collaboration among investigators, patients and all who are concerned with breast cancer.”4 Pacific Northwest Prostate Cancer SPORE - Institute for Prostate Cancer Research (IPCR)5

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Henry Ford Health System, Patient-Engaged Research Center (PERC), Head and Neck Cancer

Patient Advisory Program

“Henry Ford Health System Advisor — Serve as a representative on a hospital council or committee. You will attend meetings focused on designer or improving a new or current program, service, policy or process. (Meeting times vary from once every 3 months to once a month) Research Advisor — Share ideas and give feedback on projects, including patient reading materials and strategies to enroll people into studies. (Meeting once a month to once every two months) E-Advisors through Henry Ford Insights — Share feedback in short online surveys. Topics may include patient care experiences, communications, new services and improvement ideas, and better ways to partner with patients. (Time commitment: about 1-2 surveys per month)”6

Memorial Sloan Kettering Cancer Center, Patient

and Family Advisory Council for Quality

(PFACQ)

Patient and Family Advisory

Program

“Below is a sampling of our accomplishments: • Represented on more than 20 MSK committees • Formed core of Integrative Medicine Advisory Group • Optimized Patient Portal, MyMSK • Participated in design innovation workshops • Judged Quality Improvement Fair and selected

patient-centered grants • Developed a video series for new patients and their

family members • Participated in all 2016 and 2017 root cause analyses • Assisted with launch of supportive care initiative • Refining active-treatment-to-monitoring transition • Worked to reduce financial toxicity • Representing PFACQ and MSK”7

Methodist Hospital Research Institute,

Center for Immunotherapeutic

Transport Oncophysics (CITO), Research Projects

and Transport Oncophysics Core (TOC), Community Engagement

Program

Patient Advocates

(N=3)

“Patient advocates are our partners in the development and success of our research center: they recognize the clinical realities of cancer and the numerous burdens on patients. Their perspectives help to clearly define the needs of patients and provide a deeper understanding of the intricacies and challenges of research, particularly cancer research. Advocate involvement adds a meaningful and invaluable dimension as we continue to refine our research strategies and evaluate the data resulting from the CITO and its potential impact”8

SWOG (Global Cancer Research Community)

Patient Advocate

Committee

“They're involved in all aspects of trial design and development, ensuring that the concerns of patients - medical, logistical, emotional, financial - are addressed and that patients understand the risks and benefits of joining a trial.”9

University of North Carolina at Chapel Hill

Patient Research

“Research advocates partner with researchers and clinicians to identify areas for patient, survivor and

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Lineberger Comprehensive Cancer

Center

Advocacy Group (P-RAG)

caregiver inclusion in research and clinical trials. Research advocates provide the patient voice by: - Promoting the inclusion of patient centered materials to aid in recruitment to new or ongoing clinical trials. - Contributing to the submission and conduct of research grants requiring patient partners - Providing the patient perspective in the practicality of a clinical trial and its impact on patient care; and - Providing the patient perspective in staff and student training.”10

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Appendix B: Stakeholder Engagement at Cancer Research Centers

Cancer Research Center Stakeholder Engagement Model

Description of Stakeholder Engagement

Case Western Reserve University, Case

Comprehensive Cancer Center (Case CCC),

Community Outreach and Engagement

Community Advisory Board

(CAB)

“help advise the center and its investigators on cancer disparities and to facilitate community engagement in outreach and research. CAB brings together representatives of the Cancer Center, local community groups and health boards.”11

Charles Drew University of Medicine and Sciences

(CDU)-UCLA Cancer Center Partnership, Outreach Core

Community Academic Council

(30 Members)

Latino Community Academic Council

(15 Members)

“improve the prevention, detection and treatment and survival from cancer by integrating community engagement practices with cancer research strategies”12 “The Community Cancer Outreach, Prevention and Control Program conducts cancer prevention and control through community-partnered participatory research, bidirectional educational exchange, and capacity building with its community partners in underserved and/or socioeconomically disadvantaged populations, predominantly in the South Los Angeles Area. The Program has continued to conduct community-partnered research with support of pilot projects between community and academic faculty.”13

Edwards Comprehensive Cancer Center (ECCC) at

Cabell Huntington Hospital (W. Va)

Patient and Family Advisory Council

“Once established, the Patient and Family Advisory Council started by evaluating our supportive care offerings, but we soon learned that the Patient and Family Advisory Council had important input on almost every aspect of our program.”14

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Mayo Clinic, Community

Engagement in Research Program, Center for Clinical and Translational Science (CCATS)

Community Engagement in

Research Advisory Board

“The Community Engagement in Research Advisory Board is charged with the following duties: - Review and advise Mayo Clinic researchers on community-engaged and community-placed research. - Represent community needs in the community-engaged and community-placed research process. - Work and communicate with groups, organizations, advisory boards, individuals and stakeholders in the community (community members) to understand and identify community priorities. - Help identify community members who could partner with Mayo Clinic researchers to perform community-engaged or community-placed research. - Increase awareness for the role that research can play in solving community needs. - Utilize improved community awareness and contacts established to create a network throughout Rochester, Minnesota, that includes health care providers, community and religious health ministries, inpatient rehabilitation centers, and other health care agencies. Network members may serve as sources for disease-affected and control populations for a broad range of ongoing and future sponsored and investigator initiated project.”15

Moffit Cancer Center

Patient and Family Advisor

“As a patient or family advisor, you would partner with other patients and family members, health care providers and staff to raise issues, communicate patient and family concerns and help with problem solving, with the goal of improving our services.”16

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Seattle Cancer Care Alliance

Patient and Family Advisors

“Patient and Family Advisors improve the care experience by helping us better understand the patient and family point of view. They serve as a resource on committees, short term projects and the Patient and Family Advisory Council to improve communication between staff, patients and families and provide input in the development, implementation and evaluation of SCCA programs, policies and services. Advisors do not work directly with patients. [They] share personal experiences and viewpoints in order to aid staff in the development and evaluation of programs, services and policies.”17

Stanford Cancer Institute,

Community Engagement

Community Advisory/Action

Boards

“[Community Based Participatory Research] begins with a community-identified research topic of importance. The impact of CBPR is realized by combining collaborative knowledge and action to achieve social change; improve health outcomes; and eliminate health disparities. CBPR requires inputs from the community and academic partners from project inception to implementation, and completion of deliverables. Community engaged research (CEnR) is an approach for conducting research that is guided by the identified needs of the communities. The research, although driven by community needs, is largely conducted by the academic partner with ongoing input from the community partner. Therefore, the success of the research depends on the relationship between the two. The SCI-CPP works to facilitate both CBPR and CEnR projects, finding and matching academic and community partners with join cancer interests and concerns.” 18 Stakeholder groups include: - Sustainable Education to Eliminate Disparities (SEED) – Breast Cancer & African Americans (BCAA) Community Advisory Committee (CAC) - Breast Cancer & African Americans Conference - American Indian Community Action Board (AICAB)

University of Chicago Medicine Comprehensive Cancer Center

(UCCCC), Office of Community

Engagement and Cancer Disparities

(OCEDCD)

Community Stakeholder Participation

“The OCECD, under the direction of Karen Kim, MD, has formed strategic alliances with U-Chicago units and other healthcare organizations, as well as community, ethnic, and faith-based groups to create innovative programs that will increase access to care, reduce risk factors for cancer, reduce tobacco use, increase participation in cancer research, and improve the quality of life for cancer patients and survivors.”19

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University of Texas MD Anderson,

Clinical and Translational

Sciences Award (CTSA) Community Engagement Core

Community Practitioners

Program

“A goal of the CCTS is to extend clinical research from the Texas Medical Center to the community, incorporating the efforts of local community medical practitioners (physicians, nurses, dentists, etc.). These community practitioners, who treat the bulk of the local population, can make invaluable contributions to medical research through their observations of patients and by recruiting patients for clinical studies. In turn, participating in research can invigorate their practices and assure that their patients receive the best possible care. The Community Engagement Component can match community practitioners and CCTS investigators with similar interests and provide training in how to conduct clinical studies.”20

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Appendix C: Patient Engagement Resources and Tools Format Title Description General Patient Engagement in Research Report “PCORI Expert Interviews Project:

Final Report”21 Practical methods for engaging patients in research, patient identification and selection, eliciting stakeholder perspectives, patient training and support, dissemination and evaluation, sustainability

Journal Article “Patient engagement in research: a systematic review”22

Key findings: Most common methods to engage patients are through focus groups, interviews, surveys. Most active method of engagement is serving on a study board or advisory council and attending regular meetings with researchers. Includes observed benefits, harms and barriers

Presentation "Integrating patients’ voices in study design elements with a focus on hard-to-reach populations”23

Practical methods, standards, evidence gaps/future needs

Cancer Research Journal Article “From Principles to Practice: Real-

World Patient and Stakeholder Engagement in Breast Cancer Research”24

Kaiser Permanente’s eight principles of patient and stakeholder engagement: authenticity, real-world perspective, mutual trust, plain language, equitable partnerships, relationship building, community engagement, and feedback

Patient-Centered Outcomes Research Report “Workshop on Incorporating the

Patient Perspective into Patient-Centered Outcomes Research”25

Lessons learned, recommended practices, patient engagement challenges, evaluating engagement

Report “Draft Methodology Report: ‘Our Questions, Our Decisions: Standards for Patient-centered Outcomes research”26

Standards for patient-centeredness and engagement, principles and methods for engaging patients in healthcare research

Journal Article “Patient and Stakeholder Engagement in the PCORI Pilot Projects: Description and Lessons Learned”27

Early lessons (define roles and expectations, continuous involvement) and barriers (lack of stakeholder time, lack of research team time)

Comparative Effectiveness Research Journal Article “Continuous Patient Engagement in

Comparative Effectiveness Research”28

10-step process for CER that involves patient engagement

White Paper “Methods for Involving Patients in Topic Generation for Patient-Centered Comparative Effectiveness Research: An International Perspective”29

Evidence-based review of best practices, processes, and methods for patient engagement that have been studied and implemented internationally, and that could be adapted and used to promote patient involvement in research topic generation in the United States

Report “Patient Engagement Best Practices Resource Document”30

Report compiled by the Patient-Centered Comparative Effectiveness Research Center at

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Brigham Research Institute. Includes methods, considerations, and strategies for patient engagement in research; training and external resources

Workshop Summary

“Defining a Roadmap for Patient Engagement in Imaging Comparative Effectiveness Research”31

Workshop structure, patient engagement, and key lessons

Health-related Quality of Life Research Journal Article “Establishing the values for patient

engagement (PE) in health-related quality of life (HRQoL) research: an international, multiple-stakeholder perspective”32

Defines values for patient engagement, environmental success factors

Clinical Research Journal Article

“Patient involvement in clinical research: why, when, and how”33

This paper analyzes the reasons why patients should be more actively involved in research and designates the phases in which they could participate