Understanding the perceived impact and value of research advocacy initiatives for colorectal cancer

Research advocacy utilizes patient insight to progress research, ensuring that patient values remain a priority. It is integral to inform activities such as designing clinical trials, providing perspectives on Institutional Review Boards (IRB’s), and reviewing research grants. As a leader in colorectal cancer (CRC) advocacy, Fight Colorectal Cancer (Fight CRC) developed a formal research advocacy training program in 2015 with the goal of preparing CRC advocates to become the most educated patient voice at the research table. Methods


Introduction
The idea of patient centricity has been de ned as, "putting the patient rst in an open and sustained engagement of the patient to respectfully and compassionately achieve the best experience and outcome for that person and their family." 1 This concept is not new, and now more than ever, pharmaceutical companies, healthcare professionals, advocacy organizations and cancer organizations are leveraging the voice, thoughts, values, preferences, strengths and weaknesses of the patient to excel research, ensuring that patients, the consumers of healthcare, are actively involved. 2 Increasingly, regulatory agencies are requiring the involvement of patients, caregivers and champions of a speci c disease type along the research continuum. Also known as research advocates, these individuals in their respective elds are integral to activities such as informing clinical trial designs, providing insight on Institutional Review Boards (IRB) and voting on research grants.
In the early 2000s, it was apparent that the non-scienti c viewpoint was not at the center of research. As a representing the collective patient voice. After getting involved in regulatory advocacy, Roach realized that there were very few "squeaky wheels" in cancer research, and research advocacy could impact the community as a whole. Fight CRC also looked to those already in the eld, speci cally in breast cancer, and predicated the RATS program based on the bene ts it was having in other disease types.
Since the creation of the RATS program, over forty CRC research advocates have completed the foundational training. There are currently over twenty active research advocates who serve on panels with organizations and governmental agencies such as the Department of Defense (DoD) Peer Reviewed Cancer Research Program (PRCRP), the Southwest Oncology Group (SWOG), the Patient Centered Outcomes Research Institute (PCORI), the National Cancer Institute (NCI) and the American Society of Clinical Oncology (ASCO), as well as state-based cancer programs, local institutional review boards, and industry partner advisory boards.
With the uptick in the use of research advocates in oncology, it becomes critical to contribute to the body of evidence based on lessons learned, and understand and de ne the e cacy of a research advocacy training program and subsequently, research advocacy as a whole. This includes the perceived impact and value, as well as gaps and opportunities to enhance the ability of research advocates to effectively serve in the research process. As the RATS program enters its fth year as a formal and sustainable training program, it is necessary to evaluate the perceived value of both the program and research advocacy as a whole, and its impact on CRC research.

Engaging Stakeholders Utilizing Research Advocates
To understand the perceived value of research advocacy from the perspective of professionals in oncology, Fight   Different activities in which this group of stakeholders engaged with research advocates included: Reviewing a role-play script to help educate physicians on how to have a best practice shared decision-making conversation with their CRC patients.
Developing guidelines in Mismatch Repair (MMR) and Microsatellite Instability (MSI) testing for patients being considered for immunotherapy.
Providing commentary during meetings on what issues are important to them as patients and caregivers.
Steering committee/task force reviews which are responsible for reviewing clinical trial protocols for approval.
Developing an EAO CRC research agenda.
Reviewing an R01 proposal for clinical trials.
Serving on peer review panels alongside scienti c reviewers to provide their input on the potential impact a proposal may have on the community if successful.

Performance of Research Advocates
On a scale of one to ve, with one being completely unprepared, and ve being completely prepared, we asked stakeholders to evaluate the research advocates. The average score of respondents was 4.51 out of 5.
Additionally, participants were asked to rate their level of agreement (strongly disagree to strongly agree) on the following statements regarding their interactions with research advocates.
89% strongly agreed or agreed that the research advocate was engaged in the discussions at an appropriate level and that the group bene tted and saw the value of having a patient advocate voice. 5% strongly agreed or agreed that the research advocate showed up with the right orientation and training to serve in this role as a patient representative.
84% strongly agreed or agreed that the research advocate provided a unique perspective that wouldn't have otherwise been captured.
100% strongly agreed or agreed that the research advocate was willing to learn and that they would engage with Fight CRC research advocates again.
Responses highlighting how the research advocate contributed to shaping the conversation or leading to change included: The input was invaluable in identifying in particular 1) the level of detail some patients may wish to have explained by their physician and 2) phrases that were too technical and needed to be updated to be more clearly understood by patients.
The [research advocate] set the tone for an honest, empathetic conversation regarding the realities of living with a cancer diagnosis and how the lives of family members and loved ones are changed following a diagnosis. Additionally [the advocate] brought up multiple ideas for types of educational tools that patients might nd valuable.
We also asked what value the Fight CRC research advocates provide the scienti c community and their role in cancer research. Responses included: The CRC advocates have not only provided input into CRC, but also in other Gastrointestinal (GI) cancers. They are willing to learn about other cancers and contribute on a wider scale. They have been so essential since we have had many concepts to review in the past six months. They have been contributing and adding value with good written reviews and presenting their reviews on the phone calls with our team.
There are two values that I think research advocates will bring to research: (1) constantly reminding those that design and perform research that there are real people who will bene t from their work and (2) pointing out that sometimes what doctors/researchers assume that patients prefer is not actually what patients prefer.
Areas of improvement for research advocates that the scienti c community suggested included better representation of the collective patient experience and not a single person's perspective, preparing ahead of time the message that advocates want to convey, and increased biologic and therapeutic knowledge.
Overall, on a scale of one to ve, with one being completely unsatis ed, and ve being completely satis ed, the average ranking was 4.68. Additionally, 95% of respondents indicated a 4-or 5-star rating of their engagement with research advocates. In order to understand how the RATS program affected the research advocates' learning experience, we evaluated both change in knowledge and change in con dence. These metrics help measure the contributions of the RATS program on direct outcomes, including the impact of the training program.

Research Advocate Demographics
The top three topics that advocates increased their knowledge of the most included checkpoint inhibitors (56% increase in knowledge), the gut microbiome (55% increase) and precision medicine (55% increase). The three areas where research advocates gained the most con dence included joining a panel, board or research study as a research advocate (59% increase in con dence), being able to set realistic and timely goals as a research advocate (55%) and representing the collective patient voice as a research advocate (55%).
From the research advocate's perspective, the majority saw the program having value and impact on research. Comments included: The RATS program is a great way to get prepared advocates onto panels and other volunteer opportunities which require a knowledgeable patient voice. It provides support and peers to bounce ideas off of. It also provides info regarding open opportunities. All of these things can help push forward research by putting a face to the work researchers do and by helping to increase clinical trial accruals.
Experience and training gained from a reliable source. When people note you are a "RATS" member, they know you are in the group of lifelong learning and that you have put time and effort into your advocacy journey. The connections as well as knowledge of our fellow RATS is loaded with experience and knowledge.
Research advocates were asked to rate how well the RATS program equipped them to sit on panels and provide effective input on a scale from one to ten (one being not well prepared to ten being very well prepared). The average score was 8.4. Additionally, 100% of respondents believed their authentic patient voice has been taken seriously by the research community.
Research advocates identi ed several gaps in the RATS program which included creating a mentorship program, continuing to grow the use of community tools and resources, additional basic science training and annual in-person meetings.

Discussion
Prior reviews have identi ed common themes for effective patient centricity, including: "1) authentic and sustained engagement across the research continuum and beyond, 2) clarity in the roles and expectations of all parties engaged in the research, 3) mutual trust and respect, 4) commitment to colearning and co-production, and 5) access to the appropriate resources, supports and training." 3 It is apparent that for patient engagement to positively impact research, multifaceted approaches are necessary and numerous factors should be considered.

Creating a Highly E cacious Training Program
In order for research advocacy to have a signi cant impact and a high perceived value on research, it is important to have a highly e cacious research advocacy training program which can determine the success of research advocates' engagement in the research process. A well designed and executed program will equip research advocates with the necessary tools to successfully work in tandem with the research and medical community. Previous research conducted by Ivlev et. all has shown that online training developed for patients increases both their knowledge and skills to effectively review PCORI research with a patient centric focus. 4 Other organizations have evaluated training programs in the "basic competencies of evidence-based medicine (EBM) for selected and motivated patient and consumer representatives" and found that it is feasible and may have a positive impact on advocacy work. 5 After conducting an evaluation of the current RATS program, it is clear that Fight CRC's training program prepares research advocates to effectively engage in the research process. Based on feedback from the research community, the research advocates were very well prepared to engage in scienti cally focused conversations, showed up with the right orientation and training, provided a unique perspective and were bene cial to the conversation. From the patient's perspective, the majority increased their scienti c knowledge and con dence levels after completing training provided by Fight CRC, agreed that the RATS program equipped them to sit on panels and provide effective input and believed that their authentic patient voice has been taken seriously by the research community.
This type of evaluation feedback from both the research community and research advocates supports the notion that a training program can provide advocates with the skills necessary to engage with the scienti c community and can support the opportunity for authentic and sustained engagement across the research continuum.

Gaps and Opportunities in Research Advocacy Training
Based on the areas of improvement suggested by the scienti c community and research advocates, several gaps in research advocacy training were identi ed. Although research advocates indicated that they gained con dence representing the patient voice, the research community indicated that research advocates could continue to improve their skills by better representing a group's experiences rather than a single person's perspective.
This gap is not unique to the RATS program, or even research advocacy in general. Prior research has determined that biases may exist in research advocacy and that patient advocates may not be entirely representative of the collective patient experience. According to researchers it is important to "validate any insight through a variety of other means, such as database analyses or market research." 6 According to the article titled: "How Patient Advocacy Helps Advance Cancer Research: A Conversation on Collaboration" published by ASCO, one of the recommendations to effectively serve as a patient advocate in the research eld is to "remain grounded in the patient communities." As a research advocate, "this means working with newly diagnosed patients, attending support groups, and keeping in touch with how today's patients experience medical care and treatment." 7 An additional gap was the need to increase advocate's knowledge around biology and therapeutic knowledge. According to an evaluation conducted by the Southwest Oncology Group (SWOG) on patient engagement, a primary gap in training included "patient advocates' knowledge regarding clinical trials." 8 Both of these gaps identi ed by the research community can be addressed and improved by leveraging the RATS training framework to further implement evidence based, adult learning techniques. Bryan et al.
identi ed essential learning principles in health promotion practice including: 9 Adults' previous experience must be respected and built upon.
Adults need learning approaches that match their background and diversity Adults need to be actively involved in the learning process.
We recommend training programs like RATS utilize these principles to address the gaps identi ed. This can include involving advocates in the development of the training, understanding that each advocate comes from different professional/technical backgrounds. The training must also be comprehensive, and utilize different learning techniques such as role plays, case studies, in-person events and online modules. By providing co-learning and co-production opportunities, access to the appropriate resources, supports and training, these gaps can be addressed.

The Impact of Advocacy on Research
Understanding how research advocacy impacts the scienti c eld is essential to continue developing effective training programs and improving the ability of research advocates to work with the research community.
Based on the feedback from a diverse community of researchers and advocates, the impact of research advocacy ranges from: Identifying the level of detail patients wish to receive about their diagnosis from their physician.
Updating technical jargon to make research easier to understand for the patient.
Setting the tone for an honest and empathetic conversation and providing insight not otherwise noted.
Providing diverse insight from a range of backgrounds.
Pointing to speci c factors that are important to patients and caregivers.
Increasing clinical trial accruals.
Shaping outcome measures in clinical trials.
Deverka et. al. argues patient advocates can have a positive impact in research by, "identifying relevant research questions; alerting researchers to barriers or facilitators to enrollment; characterizing end points that matter to patients and may be differentially impacted by treatment; distinguishing informed consent or data collection issues that are unclear or burdensome; facilitating peer discussions to obtain a collective patient perspective; and assisting with dissemination and implementation of study results." 8 It becomes clear that research advocacy is not just a concept created out of principle, but rather a need that is essential to integrate along the entire cancer continuum to improve health outcomes for patients in the oncology setting.

Conclusions and Future Recommendations for the Research Community
Based on the impact research advocates can have, it is necessary for researchers and the scienti c community to understand how advocates can positively in uence their work so they may leverage research advocacy to its fullest potential. This includes understanding that "mutual respect is essential, which requires honesty and authenticity. Transparency and commitment from both parties should begin on day one." 10 Additionally, it is necessary to have, "reciprocal relationships in which both parties recognize the value of the other." 11 It is also essential to work with advocates from an array of backgrounds and communities to understand the entire patient experience. Hickey et al. argues, "There are often power differentials between the public and researchers. This is particularly so when the focus is on groups, perhaps considered as marginalized or seldom heard." 11 Not only are there opportunities for research advocacy training programs to improve the value of research advocacy, but opportunities for the Figure 1 Types of events in which stakeholders have engaged with research advocates