The COVID-19 pandemic has upended the US health care delivery system, putting a spotlight on long-standing health and economic inequities, gaps in care, uneven quality, and fragmentation in service models [1]. The rapid implementation and uptake of telemedicine and virtual care in response to the pandemic has been a positive shift [2-4]; however, existing flaws in the system remain, and new challenges to reliable system integration with virtual care are likely, especially in rural regions [5]. The impact of the pandemic on cancer care is particularly worrisome because screening and diagnostic testing have been significantly curtailed or delayed, resulting in projections of a substantial rise in excess deaths from cancer [6]. Of particular concern, patients have been reluctant to return to health care facilities out of concern for exposure to the novel coronavirus.

These compounding challenges have exposed an imperative to redesign systems of cancer care that are “anti-fragile” [7]: resilient, flexible, and democratic. In particular, techniques associated with human-centered design (HCD), such as participatory design; community engagement; and the iterative, collaborative development of sustainable solutions, have been considered essential in re-establishing trust in a health care system challenged during the pandemic [8]. In the tradition of HCD proponents such as von Hippel [9], we believe that innovation to solve problems requires working with the very people, in their own context, whom the problem affects. These are the people who understand the problem best, for whom the solutions must work, and who possess critical knowledge about local resources or potential obstacles to success.

Drawing on recommendations from a 2016 report issued by the legislatively mandated President’s Cancer Panel [10] and in the spirit of the Beau Biden Cancer Moonshot, this study describes a human-centered participatory design approach to engage patient, caregiver, and community stakeholders in solving a community-defined problem: here, the problem of serving rural patients experiencing distress during cancer treatment. The effort represents the work of an interagency, public–private partnership called the LAUNCH (Linking and Amplifying User-Centered Networks through Connected Health) initiative [11]. As a demonstration project, this study illustrates not only the richness and creativity that can come from co-design methods, but also their potential efficacy: our co-designed intervention outperformed the standard of care in usability testing.

For the demonstration project, Appalachian Kentucky was identified as a region that could benefit most from this kind of participatory design because of both positive and negative attributes: high cancer burdens, connectivity challenges related to rural geography, higher poverty rates, increased social capital, and a historical tradition of community engagement and resource sharing [12]. According to data from the National Program of Cancer Registries, cancer incidence [13] and mortality [14] in Appalachia are among the highest in the nation, and differences between counties and some unincorporated areas can show even starker disparities. Appalachia is also home to some of the most rural and difficult-to-access communities in the United States. Although these communities may benefit most from telemedicine and remote care, broadband access and adoption remain among the lowest in the country [15,16].

During the ethnographic research conducted before this co-design project, we developed relationships with community leaders in Appalachian Kentucky and identified communities where similar initiatives have had success because of high interest and engagement. Our ethnographic work demonstrated that community service and collaborative problem solving are a regular part of the social fabric of many Appalachian communities [12]. Our ethnographic work also demonstrated that more top-down approaches to systemic innovation were likely to fail in the region because of historic exploitation of the people and the land by outsiders [17].

In this context, we adopted a formal design process with roots in HCD, which is used to innovate in complex sociotechnical systems such as health care [18]. This approach may also be referred to as DesignX [19], co-design [20], or participatory design [21], each of which has been shown to improve the efficacy, adoption, and trust of new health services [8]. This approach is consistent with, and an extension of, scenario-based design proposed by Carroll [22] and borrows heavily from rapid contextual design tools that are well reviewed by Holtzblatt et al [23]. Throughout this paper, we treat co-design and cocreation as related but distinct concepts. Co-design is a set of techniques that engage all relevant stakeholders in the formulation, design, and iterative testing of ≥1 solutions to a given problem. Cocreation is the overall process of bringing together stakeholder communities to enable development of co-designed solutions, which are implemented within, and used by, these stakeholder communities.

In what follows, we describe the participatory design, development, and usability testing of a mobile app initially framed as a system to facilitate communication about cancer-related distress among patients, caregivers, and providers. We situate these processes within a novel framework we refer to as the LAUNCH Roadmap. We then present results from formative evaluation of the app and service model.

We first engaged stakeholders in Kentucky through ethnographic methods described in the study by McComsey et al [12]. These included semistructured interviews and in situ observations with patients with cancer and cancer survivors; family and caregivers; and providers, payers, technologists, and broadband providers. The purpose of the ethnographic research was to understand the experience of having cancer in Appalachia, to take inventory of the health care and connectivity resources supporting cancer care in rural Kentucky, and to develop a network of local champions to continue similar projects of inquiry and co-design.

Our participatory design process included deliberate opportunities for innovation and iteration of the process itself. This report details the participatory design process as it emerged during collaborative problem solving. The LAUNCH Roadmap combines both novel and proven approaches to participatory design. This framework is detailed in prior work by the LAUNCH initiative [11,12] and summarized in this paper in Figure 1.

According to the LAUNCH Roadmap, the innovation process begins with (1) problem identification, which is an iterative process requiring (2) contextual discovery and (3) collaborative problem defining. Next, (4) an ideation step generates potential solutions, which are further (5) refined and ultimately (6) implemented and (7) tested (Figure 1). Our process culminated in a systematic comparison of our outcomes with standard of care outcomes, a project that is underway at the time of this writing.

The LAUNCH Roadmap itself was emergent throughout our process, rather than being an existing framework to be applied (Table 1). We see the LAUNCH Roadmap as a blueprint that can be adapted to different contexts and that may emerge in different forms when iterated upon within the course of any community co-design project. As design processes must be tailored to local contexts, frameworks for implementation must be flexible and follow a bottom-up trajectory of emergence.

Methods for ideation, co-design, and development of low-fidelity prototypes were adapted from the IDEO Human Centered Design Toolkit [38] and used in LAUNCH Roadmap activities 4-6 (Figures 1 and 2 and Table 1). Ideation (activity 4) occurred over the course of 3 events in Kentucky described below. Refinement of concepts and development of prototypes (activities 5 and 6) were conducted over the course of a 4-day sprint in Lexington. Prototypes were first described verbally, then developed with low-fidelity methods such as Post-it Notes (3M) as well as whiteboards and corkboards. In parallel, a professional designer (in Toronto, Ontario, Canada), a mobile app developer (in Berlin, Germany), and a design support group (in La Jolla, California) worked as a pair design [39] distributed group to translate the low-fidelity concepts into working prototypes in 72 hours. These working prototypes were then iterated upon, in real time, by participants in Kentucky using web-based collaborative software. Further material can be viewed in the Multimedia Appendices 1-5.

This study received ethics approval from the University of California, San Diego institutional review board (record number 180589).

We planned and carried out a sequence of community-based, participatory activities in Kentucky (Figure 2). (1-3) Framing and contextual inquiry set the stage for participatory design work. (4) Ideation began in Pikeville, then coalesced at an ideation studio in Lexington, which engaged patients, providers, and caregivers to frame problems in cancer care and conceptualize new strategies to solve these problems. This work contextualized the next design studio in an Appalachian county (Jackson) where community members, patients, and caregivers were encouraged to brainstorm granular solutions to problems generated in the Lexington studio or to make practical those solutions that had been considered. (5) These concepts were presented at a subsequent co-design sprint in Lexington to select a lead candidate. (6) We then prototyped and refined this concept and rapidly developed working interventions to test in the real world with patients, providers, caregivers, and others. (7) The outcome of this work was a new software application and service model developed with participants and delivered to stakeholders for implementation and formal testing.

In this study, we report the results of an ongoing effort to improve the resilience of an oncology system, and a health care system in general, that is struggling to provide equitable access to care for patients both within and outside of the clinical encounter. Specifically, we identified the problem of remote distress monitoring for patients with cancer as an emblematic first step by which a public–private partnership could demonstrate the value of connected cancer care through innovative design methods that democratize the development of solutions. In our efforts, we began with the recognition that successful implementation of connected health solutions in real-world settings requires more than providing broadband access to patients and their care teams. Such an approach requires a careful restructuring of the local workflows and communication channels needed to give patients and their providers the confidence to engage in proactive care irrespective of physical distance or scheduled appointments. Moreover, re-engineering workflows is not something that can be done successfully from the top down; adaptation must be driven by the very individuals who understand the local context. Moreover, this process must have testable, objective outcomes to drive iteration to a clear win state that recognizes both institutional and individual needs.

To facilitate this local adaptation, we created a design and implementation framework (Table 2) informed by our collective experience in human factors, cognitive engineering, anthropology, public health, health communication, design, epidemiology, and clinical medicine. The framework began with a problem-identification stage, which framed geographic areas for contextual inquiry through the combined triangulation of epidemiologic data from registries of cancer burden with industry-level databases on broadband access. The results of these quantitative studies were then used to guide further discovery, problem refinement, and ideation through ethnographic observations, interviews, and semistructured group meetings in those areas of Appalachian Kentucky struggling with the double burden of poor cancer outcomes and lack of access to broadband. These locally co-designed solutions were then prototyped, refined, and tested as part of an implementation solution in Appalachian Kentucky. Clinical trials are currently underway to test the efficacy of these solutions.

Our goal in publishing these results at this time is to give an indication of how use of the framework could help inform design decisions from the ground up as communities adapt to the complex interplay of remote telemedical options and in-person consultation in a period of intense change in health care. In our case, the ethnographic work we conducted in collaboration with MCC and MCCAN highlighted a need to adapt the traditional verbiage and approach of the NCCN-mandated stress measures to improve buy-in (adoption) and increase comprehension, consider a wellness frame (as opposed to a sick frame), and increase patient and provider engagement. This is just one aspect of system redesign that may often be overlooked without careful examination of patients’ (people’s) values and predilections in the geographic regions in which they are served [16]. Once these were identified, we engaged in co-design efforts with these groups to improve how the instrument could address community prioritized needs in a manner that is locally acceptable, effective, and sustainable.

The results from our iterative evaluation process showed incremental improvements in usability and learnability among patients as we progressed through our iterative development path from the paper-based NCCN DT to a reworded version of the paper-based instrument to a digital adaptation of the NCCN DT and finally to an electronic adaptation of the myPath app. Providers, on the other hand, seemed to be less comfortable with the earlier iteration of the paper-based myPath tool than patients. This seemed to be because clinical staff were more familiar with the traditional language in the NCCN DT and thus felt more comfortable with the existing verbiage. Nevertheless, providers responded with even higher usability and learnability ratings than patients when exposed to the final electronic version of the myPath app. Providers also offered extremely high ratings for the myPath dashboard. From our experience, it seems that the clinical staff grew more appreciative of the form and intent of the project the closer it progressed to its final operable format. The oncology teams were especially taken with the enhanced capacity the dashboard offered in management of caseloads across patients.

When we began our efforts, we relied on an evolving evidence base in cancer care suggesting that strategic deployment of remote, point-of-need technologies can offer instrumental gains for improving medical outcomes, protecting quality of life from the burden and cost of travel to appointments, and for offering intervention opportunities well before emergency services may be needed. In other words, we were following a typical evolutionary path for implementation in cancer care; one that—just like telemedicine more generally—would take years to complete.

Since then, we have watched as the necessities for physical distancing during the COVID-19 pandemic have pushed policy makers and health care administrators to move more rapidly on making connected care an integral part of 21st century medicine. Changes have included provisions for reimbursement by the Centers for Medicare & Medicaid Services, a relaxation of jurisdictional barriers across state lines, a softening of privacy restrictions under the Health Insurance Portability and Accountability Act, and the provision of financial incentives for building out broadband support for medicine within underresourced communities. It is unclear at this time how much of this policy change will continue after the pandemic subsides. What is clear is that a focus on HCD will be crucial as we iterate forward toward new service models in a rapidly changing and continuously challenging time. What is also clear is that these changes in the medical landscape will go well beyond the benefits they may convey to cancer care; they will be applicable to all other facets of care as we move to create an antifragile system for patients and the professionals who care for them.

This paper presents a framework for guiding HCD activities at the community level. It also offers insight into the process of applying the framework to the specific objective of improving distress monitoring processes for patients with cancer living in rural areas surrounding MCC in Lexington. As noted earlier, these efforts are part of the LAUNCH initiative [11]; therefore, it is only one part of a larger, unfolding story. Clinical pilot studies are currently underway to gauge the overall impact that our HCD efforts are expected to have on system and patient metrics. The true test of a community-based HCD approach will not be completely evident until much farther down the line.

Another limitation of this study is that it offers only one example of how a community-driven design approach could be applied to meet the needs of an academic medical center serving a largely rural catchment area. The way to scale the approach, we believe, is to offer pathways by which other communities around the country could apply best practices in HCD to their own local jurisdictions following a true platform-based model of deployment [44]. Future efforts are planned to create a Platform for Agile Development (ie, LAUNCH-PAD) to facilitate local resource matching, knowledge transfer, and a guided application of HCD resources and data within the local context.

In this work, we described the implementation and testing of a co-design framework developed to address a global need for rapid health system innovation that generates effective and locally sustainable solutions that can scale laterally to promote resilience in the system. We hypothesized that this antifragile approach, bridging lead-user innovation with equity, diversity, and inclusion through co-design, could promote resilience in rapidly changing and increasingly uncertain times. Through this process we showed that codeveloped solutions addressing community-defined problems could be produced quickly, with broad stakeholder input, balancing goal-oriented, time-limited development with open and inclusive dialog. In conclusion, we encourage bringing together people with lived expertise and diverse and even dissimilar views because this creates the circumstances and creative outputs required for resilient, scalable, and locally acceptable solutions.