TeamScience@SWOG Field Guide

TeamScience@SWOG Modules provide guidance for specific research team tasks, and inclusive strategies to complete those tasks, in support of robust and consistent Advocate engagement across all

stages of research.

Overview TeamScience@SWOG Modules

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Module 1: For Leaders: Enabling, Reinforcing, and Rewarding Patient Advocate Engagement orients Executive Officers and Leadership, Committee Chairs, and Study Chairs to a vision for the engagement of Patient Advocates in every stage of research.

Module 2: TeamScience at SWOG provides strategies and downloadable tools to support Patient Advocate engagement in each stage.

Module 3: Engaging Patient Advocates in the Define, Review, Design Stages explains the specific tasks within these stages, and how Patient Advocates contribute.

Module 4: Engaging Patient Advocates in the Implement Stage explains the specific tasks within the Implement Stage, and how Patient Advocates contribute.

Module 5: Engaging Patient Advocates in the Share Stage explains the specific tasks within the Share Stage, and how Patient Advocates contribute.

Table of Contents

Introduction

The TeamScience@SWOG Field Guide has been prepared for leadership of clinical research organizations (Executive Officers, Senior Leaders, Committee Chairs, and Study Chairs a/k/a Principal

Investigators or PI’s) and for all study team members to support equitable partnership in research activities.

TeamScience@SWOG provides a framework for clinical trials research that supports Patient Advocate engagement through inclusive team dynamics, enabled by six key strategies. This Field Guide is intended as a catalyst for the team and its leadership, providing guidance and opportunities that collectively define culture and values and stimulate continuous improvement. The most critical takeaway from the TeamScience@SWOG training and the related Field Guide is clarity about opportunities for Patient Advocate engagement across the research life cycle, along with strategies for increasing engagement at any point in the study team’s work.

A framework is meant to improve and shape, but not burden nor constrain, a process – TeamScience@SWOG is no different. As you collectively put the Field Guide into practice, keep in mind:

• Calibration – the adjustment of expectations based on the trial and the expertise and bandwidth (available time) of the Patient Advocate – and role clarity are the cornerstones of TeamScience and high-performance teams. Without them, the team faces voids or collisions in work and lost opportunities.

• Adapt the Field Guide to the circumstances – one size does not fit all. Prioritize specific places to improve patient advocate engagement within the context – you can’t do everything, nor can you plan for all possibilities. Over time, opportunities will present themselves and the team’s needs during particular stages of the clinical trial lifecycle are unique to the context.

• Leaders will need to delegate as well as model team-oriented behaviors. They cannot be everywhere, nor should they be. Their role is enabling, reinforcing, and rewarding a culture of engagement.

Calibration of Patient Advocate Engagement

Research organizations, committees, study teams, trials, and Patient Advocates themselves are unique in terms of how they operate and the possibilities that they offer. It is therefore not

surprising that Patient Advocate engagement varies.

Conversations between the Patient Advocate and Leadership (Study Chair, Committee Chair or organization leaders) to calibrate the role to the context and to the Advocate’s skills, experience, and available time are a critical success factor to optimize engagement. Committee Chairs and other leaders’ conversations about the Advocate’s involvement in the Committee support their engagement at the portfolio and concept stages and beyond while Study Chair and Advocate conversations may be particularly fruitful during concept development or at the start of trial stages.

Robust Patient Advocate engagement is captured by these statements:

• Researchers agree that they embed their Patient Advocate throughout the research process as a trusted partner.

• Advocates agree that they are embedded into the research process and proactively provide significant insight, feel safe in offering opinions which are valued, and take accountability for the team’s area of focus.

NATIONAL CANCER INSTITUTE

How Advocates Support the Clinical Trial Life Cycle

Clinical Trial Development Process

Def

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1 Analyze portfolio

Create portfoliostrategy

Propose concept

Analyze data

Publish results

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Advocate’s Role

• Provide feedback that frames trial questions important to patients

• Provide support for balanced trial portfolios across treatment, prevention, and control, where science supports research

• Review trial inclusion and exclusion criteria for maximal patient participation where safe and possible

• Collaborate on protocol development

• Provide feedback on communications and patient-friendly materials

• Create awareness around need for patient accrual

• Provide input on trial accrual strategies and offer support

• Share study results with appropriate patient and advocacy groups through interviews, presentation, publication, and social media channels

Patient Advocate Engagement Across the Clinical Trial Lifecycle

The National Cancer Institute (NCI) has defined five stages for the clinical trial lifecycle: Define, Review, Design, Implement, and Share. Patient Advocates support each of these stages with activities

representing the core scope of work they do in a clinical trial context.

The infographic below shows the stages, their subprocesses, and associated Patient Advocate activities, and is the cornerstone for TeamScience@SWOG. Leaders should consider how well the Advocate is being engaged and supported in these activities.

Calibrate and Clarify Roles Worksheet

The process of calibrating and clarifying roles is critical to the success of any high-performance team. The Study Chair is responsible the Patient Advocate’s role being clear and aligned with their available time, skills,

experience, and needs. But this cannot be done without help. The Protocol Coordinator, the Patient Advocate, and other members of the study team support those goals, with coaching and mentoring from Committee Chairs, Executive Officers, and Leadership.

Specifying the role of the Patient Advocate so that it incorporates their skills and experience while respecting availability, can be both proactive and reactive. A future opportunity requiring significant bandwidth (available time), or a pattern of missed opportunities for engagement, should trigger conversations by one or more of the players.

The most critical enabler to “calibrate and clarify” the role of the Patient Advocate is also the most basic: comparing current, planned, or historical activities to the Patient Advocate activities within the Life Cycle. This companion worksheet supports that process.

The study team has a number of opportunities to clarify their Advocate’s role, and they include in person, phone, and email interactions such as:

• Ad hoc status checks initiated by any member of the study team or by any member of leadership

• Annual evaluations (Patient Advocate and Committee Chair)

• Committee meetings

• Trial kickoffs

• Executive Review preparation or debriefs

• RaPID meetings

• Lessons learned and continuous improvement discussions after stages or trials are completed

Beyond that, the strategies covered in Module 1 For Leaders; Enabling, Reinforcing, and Rewarding Patient Advocate Engagement frame the actions of Committee Chairs, Executive Officers, and Executive Leadership as they, too, “calibrate and clarify” the role of the Patient Advocate:

1. Lead by example

2. Mentor Study Chairs and Patient Advocates

3. Use 1:1 and large group to build collaboration

4. Acknowledge and actively address power differentials

5. Active listening

6. Coach Patient Advocates

7. Recognize and encourage Patient Advocate contributions

To build skills in calibrating and clarifying roles including the Patient Advocate, use the “Try This” activities below.

Calibrate and Clarify Roles Worksheet

TryThis | As a Patient Advocate or Study Chair, after you identify a particularly challenging accrual problem:

• Can we discuss my [or your] role with regard to addressing the accrual challenges I anticipate on this trial because of [root cause]?

TryThis | As a Patient Advocate, after you note that your team is considering a course of action that seems at odds with your experience:

• “I have seen and heard many comments from survivors on this topic which runs contrary to this.”

• “Could I suggest that I ask a question on [this relevant web forum] or ask [this advocacy group] to ask a random sample of patients about this before we finalize this decision?”

TryThis | As a Protocol Coordinator, after you note the absence of the Patient Advocate on a communication:

• [to Study Chair] I’ve added the Patient Advocate to this discussion. I have noted some valuable feedback on this topic from Advocates in my other Committees.

TryThis | As an Executive Officer or Executive Leader, after you have noted differences in involvement by Advocates in a particular Stage:

• [to Committee Chair, Study Chair or Patient Advocate] I have observed some high impact work being done by Advocates in other Committees during the Implementation stage that I think could be very helpful in this Committee. Here is what I have seen . . . .

Calibrate and Clarify Roles Worksheet

TryThis | As a Patient Advocate, during annual evaluation process:

• [to Committee Chair] As I looked across the trials that I supported over the past year, I noted that I was not as fully engaged in [Stage] as I would like to be. I spoke with some of my Advocate counterparts, and here are some ideas to improve that . . . .

• Ask: How can I be more effective in the future?

TryThis | As a Committee Chair or Study Chair, after trial closure due to full accrual on a challenging trial:

• [to Patient Advocate at the semi-annual in-person meeting] I want to thank [Advocate] for the help in turning around this trial. Your insights and countermeasures kept this trial open, made this trial better, and allowed us to close it with full accrual. I think it would be helpful for all of us to include the Patient Advocates in accrual countermeasures. For reference, here are the actions taken in this trial . . . .

TryThis | As a Study Chair, after receiving approval from the sponsor (NCI or other sponsor):

• [to Patient Advocate] I am glad that you asked to discuss your role on this trial. I have not worked with Patient Advocates in the past on the [pick one or more: Define/Review/Design/Implement/Share] Stage. Can you help me understand how you support that Stage?

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Representing the Patient Perspective Worksheet

The Patient Advocate’s primary contribution is to represent the patient perspective, which ideally includes a broad knowledge of the particular disease and its treatments, the concerns of the patient disease

community, and their own experience. Although the Advocate may be uniquely able to consider study issues from the participant’s point of view, other members of the team should work toward building their own ability to take on the patient’s view and may well have considerable clinical or personal experience to draw on.

There are a number of aspects of a protocol that should be considered from the patient perspective. They include:

• The primary outcomes of the study

• Study design elements (eligibility, comparators, primary and secondary endpoints, patient reported outcomes, and study burden)

• Feasibility of the study in reaching accrual targets

As the study goes through early stages of concept development, Executive Review, and protocol development, the questions below can be asked again and again, yielding progressively richer and more informative answers.

TryThis | Ask these questions to investigate the patient’s perspective.

Primary Outcomes

• Will the results matter to patients and their caregivers, e.g., better health outcomes? Better quality of life? Fewer side-effects: lower costs?

• In the best-case scenario, what information will be gained from this study?

• Will this knowledge still be relevant by the time the study is likely to be completed?

• How may future patients be affected by the results of the study?

• Are there alternative, less costly or less time-consuming ways to obtain the same knowledge?

Study Design Element/Eligibility

• Who is included and why?

• Who is excluded and why?

• Are eligibility criteria translatable to a more general cancer population?

• Including diverse populations?

• Could the primary question be answered with fewer patients?

Study Design/Intervention

• How strong is the evidence that the intervention will be effective?

• How much benefit is it likely to have?

• If a drug trial, what drug, dose and schedule of administration will be used?

• What alternatives were considered?

• If not a drug trial (e.g., radiation, surgery, psycho-social, quality of life, etc.), what types of interventions were considered?

• Will supportive therapies (e.g., drugs provided to counteract side effects) will be provided? If so, under what circumstances?

• Under what circumstances will aspects of the intervention be modified?

Study Design/Comparator

• Is the control intervention appropriate?

• How are placebos used? How effective is the standard intervention?

• Is there blinding?

• What issues beyond the treatment might affect the outcome?

• If patients do relatively poorly in the control group, is cross-over allowed?

Study Design/Primary Endpoints

• Is the outcome important to patients?

• Is the expected minimum difference meaningful enough to patients?

• Will it allow the trial to rapidly lead to definitive conclusions?

• How will it be measured?

• What alternative outcomes were considered and why was this one chosen?

• Are the measures appropriate given the objectives of the study?

• Why not include patient reported outcome measures in this study?

Representing the Patient Perspective Worksheet

Requesting, Giving and Receiving Feedback Worksheet

As collaborators, Patient Advocates, Study Chairs, and other research team members must be able to talk about each other’s ideas and suggestions. One key skill to make those conversations productive is

feedback. Use these guidelines as a checklist to formulate feedback you are giving and review the example to see them illustrated.

• If you can’t think of a constructive purpose for your feedback, don’t give it at all!

• Focus on description rather than judgment

• Focus on observation rather than inference

• If it’s about a person’s behavior, rather than a work product, focus on behavior rather than the person

• Own your thoughts and feelings; state them clearly

• Balance positive and negative

• Be aware of feedback overload

Similarly, use these same guidelines for receiving feedback:

• If you’re unclear about what the feedback is about, ask questions to clarify

• Acknowledge the feedback with a neutral restatement

• Focus on explaining, not defending, your position or idea

• Consider how the feedback might improve things

• Propose how you would address the feedback

• Clarify what is going to happen next

Here are some examples of giving constructive feedback:

1. “I thought the informed consent was pretty strong, there was only one part of it I would like to discuss” (both positive and negative feedback; one issue at a time works well)

2. “I think my suggestion will strengthen our ability to recruit patients” (this is your constructive purpose; lead with it!)

3. “I think the description of the bio-specimen collection is overly complicated. Can we delete all but the first two sentences, which I thought were well done and comprehensive?” (description of what you’re commenting on, and a suggested solution)

TryThis | As a Patient Advocate, after you have given someone feedback on a concept, ask for feedback on your feedback.

• Was my feedback balanced, e.g., did you hear what I liked, as well as what I suggested changing?

• Was I clear about where my feedback was coming from, e.g., a concern about patient experience; or clarification needed for lay audience?

• Was the change I suggested feasible?

TryThis | As a Study Chair, schedule time at the end of study team meeting for feedback on the discussion. Ask these kinds of questions:

• Did we strike a good balance between getting through the agenda, and hearing from everyone?

• How did I do at listening to your feedback?

• How did the team do at listening to feedback?

• What obstacles to participation could we do away with for next time?

• Did any issues remain unresolved?

TryThis | As a Protocol Coordinator asking for feedback on a protocol, ask specific questions with your email/in your phone call that invite the feedback you are looking for. Try asking for suggested solutions as well as identified problems. Examples are:

• Can you identify any concerns you have about burden on patients? Can you suggest a way to decrease that burden?

• Is there any way you see to improve the likelihood of patient participation? Please suggest improvements.

• Do you think the study outcomes will be important to the broader patient community? If not, can you say why?

• Are there study populations that would benefit but are being excluded? If so, which ones, and how are they excluded?

Requesting, Giving and Receiving Feedback Worksheet

4. “It sounded overwhelming to me as it’s described, and I wasn’t entirely sure what it meant.” (your thoughts and feelings)

5. “Can you help me understand what you meant?” (Leave room for the other person to respond.)

6. “What if we described it like this?” (offer specific wording)

7. Summarize the change agreed on and express your appreciation for their responsiveness

To build your team’s skill in giving and receiving feedback, use the “Try This” activities below.

Advocating for Your Perspective Worksheet

All teams will experience differences of opinion. One goal of including Patient Advocates on study teams is to ensure that the patient perspective is one of several perspectives that members should be

voicing, including scientific, logistical, ethical and other perspectives. A key distinction in how those differing opinions are shared is to aim for dialogue, rather than debate. Dialogue is collaborative and works toward a common understanding. Debate is oppositional and aims to prove one side is right while the other is wrong. Follow these best practice guidelines in order to support productive dialogue.

Sometimes it may be necessary to ‘advocate’ for a change in process or meeting norms, to make space for advocating for a position. For example, if your team always ‘runs out of time’ before everyone gets a chance to speak, ask for a change so that the discussion leader asks halfway through the meeting if everyone has had a chance to speak.

Best practice guidelines

• I-statements, such as “I think”, “I believe”

• State your goal: what is the outcome you are trying to achieve with this input?

• Pros and cons: promote your point of view while acknowledging downsides if you see them. How does your point of view strengthen or advance the study?

• Contextualize: where is your point of view coming from?

• Provide evidence that clarifies, rather than making your case: your experience? Information from advocacy groups? Peer-reviewed journals? Other trials?

To build your team members’ skills in advocating for a perspective, use the “Try This” Activities below.

TryThis | As the Study Chair developing a concept, when you are discussing the concept with one or more people, try out these questions to invite others to advocate for their perspective:

• “From your point of view, how important would the outcomes of this study be? Who do you think would benefit the most from it?”

• “What do you think the biggest down side is to what I’m proposing?”

• “How do you think this concept could be improved?”

• “If you could change one thing about this concept, what would it be?”

TryThis | As a Patient Advocate asking for a change in a protocol, consent form, accrual plan or other issue, experiment with this format for your comments:

• “If I think about this [protocol; exclusion criterion; consent form] from the point of view of a patient who is [female; male; a certain age], this is what jumps out at me:”

• “Let’s look at this from the point of view of different patients. What concerns would older patients have with this trial? What about young patients? Hispanics? African-Americans?”

TryThis | As a Protocol Coordinator, invite study team members to advocate for a perspective by asking:

• “Can you look at this consent form from the perspective of the clinician explaining it to a patient? What works/what might not?”

• “From the point of view of a single parent, what would you think of participating in this study? As an older adult? As a person of color coming to an unfamiliar medical facility to participate?”

• “In our discussions about this [protocol; consent; accrual plan; eligibility criteria], whose perspective have we missed (Study participants; implementing clinicians; site coordinators)?”

Advocating for Your Perspective Worksheet

Practicing Empathy and Listening Worksheet

TryThis | During early discussions of concepts, tune in to what the Study Chair seems to care most about, and discuss it with him/her:

• “Listening to you talk about this, it sounds like what matters most to you is ….”

• “I can tell you’re excited about this idea; can you tell me what the heart of it is for you?”

• “I think you’re saying patients would benefit because the study would [fill in the blank]. Am I understanding you?”

TryThis | During early discussions of concepts, tune in to what the Patient Advocate seems to care most about, and discuss it with him/her:

• “Listening to you talk about this, it sounds like what concerns you most about this concept is ….”

• “I can tell you’re excited about this idea; can you tell me what the heart of it is for you?”

• “I think you’re saying that some patients who should have access to participating would be excluded from this study because of [fill in the blank]. Am I understanding you?”

Webster’s dictionary defines empathy as ‘the action of understanding, being aware of, being sensitive to, and vicariously experiencing the feelings, thoughts, and experience of another…without having

[those things] fully communicated in an objectively explicit manner’.

The definition above also emphasizes that empathy is an action, not a passive state, and requires our intention to understand and be aware of another’s experience.

Listening to another person is the primary avenue for experiencing empathy, particularly in our increasingly virtual world of relationships. Listening, or active listening as it is often referred to in the context of interpersonal communication, is also a skill to be practiced. In fact, active listening guidelines often include:

• Practice empathy

• Listen attentively

• Reflect back what you’ve heard

• Don’t offer advice, give suggestions, or interrupt with your own experience

• Ask open-ended questions

TryThis | During discussions of the study protocol, try taking on the different perspectives of your study team members, or of study participants, and asking questions:

• “If I were the Protocol Coordinator on this study, should I be concerned about [identify a concern you think they might have]?”

• “From the point of view of a patient who is trying to work, how much disruption to my work week should I expect?”

• “As the biostatistician on this study, would I be unhappy about the number of study sites being proposed?”

TryThis | As you analyze data, try restating what other people are saying, especially if their point conflicts with one of your own:

• “So, from your point of view, you think the data suggests this correlation? [restate what you heard]?”

• “If I’m hearing everyone correctly, these are the three main findings of this study [restate what you heard]”

Practicing Empathy and Listening Worksheet

Facilitating Inclusive Discussions Worksheet

TryThis | To create an inclusive environment, discuss these suggested ground rules, modify them as needed and ask your team to commit to them. Consider including them as reminders on meeting agendas as your team works together.

• Listen respectfully, without interrupting.

• Listen actively and with an ear to understanding others’ views.

• Criticize ideas, not individuals.

• Commit to learning, not debating. Comment to share information, not to persuade.

• Avoid blame, speculation, and inflammatory language.

• Allow everyone the chance to speak.

• Avoid assumptions about any member of the class or generalizations about social groups. Do not ask individuals to speak for their (perceived) social group.

TryThis | As a final agenda item, discuss whether these “non-inclusive” dynamics happened:

• Were certain conventions or language used that excluded certain groups or individuals from understanding the discussion?

• Were assumptions made about the expectations or interests of participants, e.g., assuming all held the same ones?

• Was disrespectful language or tone, or disrespectful non-verbal communication, part of the meeting?

• Was the discussion unbalanced, e.g., one or more participants took over the conversation?

• Were alternate views or counter-arguments discouraged in any way?

Creating inclusive discussions requires effective facilitation and productive participation by all members of a team. Effective facilitators model inclusive behaviors that members should practice as well. An

inclusive discussion allows all participants to explore ideas while recognizing and supporting the contributions of all.

To build your team’s skill in inclusive discussions, use the “Try This” activities below:

TryThis | State that you want to encourage inclusive participation during a meeting by using some or all of these practices:

• Ask follow-up questions and paraphrase the comments for everyone to ponder. A combination of initiating and probing questions can be an effective approach to bring out participants’ ideas further.

• Ask contributors for further clarification and/or elaboration.

• Re-visit past contributions and incorporate them into subsequent discussions.

• Encourage others to add their reactions or ideas to build on someone’s comment.

• Don’t be afraid to admit your own ignorance or confusion if you don’t know something; invite others to explain or provide resources.

TryThis | At the end of a meeting, or periodically as the team works together, poll your team with these questions:

1. People in the group respected my opinion

Disagree Strongly

Disagree

Agree

Agree Strongly

2. I spoke as much as I wanted to in the group Y N

3. There was enough time to fully discuss all the relevant issues Y N

4. The Study Chair/Facilitator ensured all opinions were considered Y N

5. I understood the issues well enough to participate as much as I wanted to Y N

Facilitating Inclusive Discussions Worksheet

Measuring Progress Towards Patient Advocate Engagement

Project Co-Leaders:

Patricia Deverka, MD, American Institutes for Research; Rick Bangs, MBA, PMP, SWOG Patient Advocate Committee Chair

Instructional Designer: Sue Vargo, Psy.D., American Institutes for Research.

Project Advisory Group

Dr. Charles Blanke, SWOG Group Chair, Oregon Health Sciences University

Dr. Scott Ramsey, Director of the Hutchinson Institute for Cancer Outcomes Research, SWOG Cancer Care Delivery Group Co-Chair

Dr. Dawn Hershman, Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center, SWOG Executive Committee

Dr. Ian Thompson, President of CHRISTUS Santa Rosa Medical Center Hospital, SWOG Genitourinary Committee Chair

Ms. Dana Sparks, SWOG Director of Operations

Ms. Amy Williams, Acting Director, Office of Advocacy Relations, NCI

Ms. Jane Perlmutter, Patient Advocate, Training Expert, President and Founder of Gemini Group

SWOG Patient Advocate Reviewers

Mr. Jack Aiello (Myeloma)

Ms. Amy Geschwender (Symptom Control & QOL)

Ms. Hildy Dillon (Lymphoma)

Ms. Judy Johnson (Lung)

Ms. Florence Kurttila (GI)

Ms. Ginny Mason (Breast)

Ms. Carole Seigel (Pancreatic)

End User Group

Ms Valerie Guild, Vice Chair SWOG Patient Advocate Committee

Dr. Veena Shankaran, Associate Professor, Medical Oncology, University of Washington School of Medicine; Assistant Member, Clinical Research Division, Fred Hutchinson Cancer Research Center; SWOG Principal Investigator

Sandi Hita, SWOG Protocol Coordinator

This training was funded through a Patient-Centered Outcomes Research Institute© (PCORI©) Eugene Washington PCORI© Engagement Award (#6180-AIR) and developed by the American Institutes for Research (AIR).

The views and statements presented in this work are solely the responsibility of the authors and do not necessarily represent the views of the Patient-Centered Outcomes Research Institute© (PCORI©), its Board of Governors or Methodology Committee, or AIR.

Version 1: September 2018

AcknowledgementsTeamScience@SWOG, including the Field Guide, includes the contributions of the following individuals: