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Founded in , SWOG now has more than 12, members in 47 states and six foreign countries. As part of SWOG, DE intends to help build an evidence base by describing the potential gains and limitations of social media and online tools when applied to the clinical trial enterprise. We have developed guiding principles Table 1 that will allow us to develop projects specific to DE and to support SWOG clinical trials.
As our initial foray into this uncharted area, the Committee has decided to focus its efforts in the following three distinct spheres: the use of digital tools to simplify the consent process; the use of digital methods to engage our members; and the use of digital tools to inspire the public. Table 1.
Guiding Principles for Digital Engagement. Fig 1. Digital engagement in SWOG: A conceptual model of digital engagement integration into the work of disease site committees. Dizon Chair , Charles A. Pal, Anne Schott, Mina S. SWOG recently completed an online survey of survivors of cancer to determine their information sources and needs. Given these findings, DE identified clinical trials as a priority area and focused on the informed consent process as a starting point for innovation.
Informed consent has the following two main aims: to respect and promote autonomy of patients and to protect patients from potential harm. Unfortunately, informed consent documents are lengthy and complex, and this problem is increasing, particularly in the era of targeted treatments where multiple cohorts are being enrolled based on the presence of a tumor characteristic or risk biomarker, such as in the NCI Molecular Analysis for Therapy Choice MATCH trial ClinicalTrials. Various remedies to make informed consent more effective have been evaluated.
Although all interventions were associated with improved understanding, both enhanced consent forms and extended discussions were significantly more effective. More recently, Tait et al 10 , 11 have evaluated the potential benefit of using an iPad-based informational program on the consent process. Although these data are provocative, these studies were not specific to cancer clinical trials.
However, they provide some hope that we can improve the consent process using digital tools. Therefore, the DE will evaluate innovative methods to simplify informed consent that will aim to improve satisfaction, increase comprehension, and, ultimately, improve retention of participants. The growth of online communities consisting of patients, providers, and advocates is robust, and an emerging literature has shown that these communities can yield results and prompt behavior change. Attai et al 12 performed a survey of participants in the Twitter breast cancer social media community.
Whether SWOG members are ready to participate remains uncertain. However, we believe that provision of structure can result in increased engagement. Katz et al 13 evaluated the use of Twitter hashtags before and after the online publication of an organized cancer tag ontology CTO in On the basis of this experience, we aim to evaluate other structured formats to encourage and allow for digital engagement of our members. Clinical trial awareness remains an important priority for SWOG.
A key barrier to clinical research participation is the lack of an overall public awareness about clinical trials and cooperative groups and an understanding of how they relate to the progress we have seen in oncology. Whether digital engagement will increase public interest in the clinical research enterprise and ultimately improve accrual rates is not known.
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Sites such as Just Another Lab Rat! Sedrak et al 15 demonstrated that a significant percentage of ongoing lung cancer—related discussions on social media included a mention of clinical trials, which suggests that there is an opportunity to connect patients, caregivers, and the public in general with investigators.
In addition, Wagle et al 16 developed a social media campaign to support direct-to-patient involvement in basic science research in metastatic breast cancer. Efforts are now under way to understand who is participating in online conversations. Khasnavis et al 17 evaluated tweets sent in the 6 days before and after the US Preventive Services Task Force USPSTF released their draft guidelines endorsing the use of low-dose computed tomography scans for lung cancer screening. In a USPSTF analysis, Prabhu et al 18 evaluated chatter on Twitter after the release of recommendations against the use of prostate-specific antigen to screen for prostate cancer.
There was also a significant increase in tweets against screening and in tweets with links to antiscreening articles. Nonetheless, most tweets were reported to be void of an opinion ie, sharing information only. Still, we believe that social media may be an effective tool for introducing a well-informed opinion and to increase awareness of sound medicine, science, and clinical research to the public, provided key stakeholders are able and willing to engage. Such a proposal was suggested by Chan et al, 19 who identified the following three aspects required for the timely adoption of evidence-based medicine: clinicians able to critically appraise new research; translational teachers who can work with researchers for more effective dissemination; and interactive investigators willing to engage clinicians.
We acknowledge that there are many barriers to the incorporation of digital tools by stakeholders, including limited digital literacy, infrastructural barriers to Internet access, and socioeconomic limitations, among others. In a recent article in Time magazine, Vick 20 discusses the digital divide in the United States and the fact that one quarter of US citizens lacks access to broadband, which is a problem not likely to be solved without a federal commitment to provide universal Internet access.
Increasing age, lower annual incomes, and a more limited education are associated with lower levels of digital engagement, whether that be home broadband, adoption of new technology, or owning a smartphone. Therefore, the assumption that older adults are not likely to engage should be challenged and empirically tested, especially because the inclusion of this particular population remains an issue in clinical trial enrollment. Convincing colleagues to adopt digital technologies is also a barrier that must be overcome.
Through the empaneling of the DE, there is now a strong signal to SWOG that we can and should embrace digital engagement. The notion that social media can effectively raise the awareness of clinical trials in the public consciousness has been suggested and deeply desired, although not without concerns.
Because e-health technologies are relatively new, best practices have not yet been established for the use of digital tools as part of the clinical trial enterprise.
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Where social media is used to spur action on a potentially eligible patient, the role of institutional review board review is important to ensure compliance with the Health Insurance Portability and Accountability Act privacy rule, which prohibits the collection of personal health information without written authorization.
Thus, we will need to consider this early in clinical trial development, as part of any recruitment strategy, and throughout the conduct of any trial. Finally, whether a public service campaign can move the needle on clinical trial enrollment remains to be seen. We note that, to date, there is no clear signal that a greater public awareness of clinical trials imparts a positive impact on clinical trial recruitment and participation.
Indeed, online forums populated by patients may share adverse effects, inconclusive findings or early findings, or how to determine through outside laboratory tests whether a patient is on a placebo or therapeutic arm of a clinical trial, thereby stifling enrollment and, ultimately, the successful completion of clinical trials. However, engaging the public may be beneficial by increasing the identification of clinical trials as valid treatment options and by imparting a greater recognition of the federally funded cooperative groups that are devoted to clinical research.
Our team must also address the return on any investments in digital technology as it pertains to administrative and clinical trial outcomes: Do tweets on trials result in more patient consent? Can Facebook engagement reduce the rate of protocol noncompliance? What are the tangible benefits for SWOG members who engage online? These are examples of important questions that SWOG can address in a strategically aligned way through the DE, and the outcomes will not only impact SWOG, but also clinical trialists nationally and internationally.
Future efforts may entail increased efforts to maximize bidirectional communication. Indeed, data have illustrated the benefit of such channels between patients and their treatment teams. In another trial of patients with lung cancer undergoing surveillance, a Web-based system that allowed patients to self-report symptoms was associated with improvement in overall survival compared with standard follow-up; the improvement in survival was a result of earlier detection of relapses and a better performance status of patients at the point of recurrence.
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Although digital tools have become a widespread part of society, their use in medicine and, specifically, in the clinical trial process remains largely untested. Whether such tools can be harnessed to improve the awareness of vital clinical trials in oncology is an area rich for exploration, and SWOG intends to lead the way through our new commitment to study and incorporate digital engagement as part of our work. Through this effort, the SWOG DE aims to provide the evidence base for—or against—the use of varied platforms in the pursuit of modernizing the clinical trial experience and process.
Conception and design: Don S. This constantly evolving picture of tumor biology is helping to shed new light on the behavior of many cancers, as well as providing new pharmacological targets and treatment strategies. Much of this progress has been driven by technological advances, and the last decade has seen huge strides made in the field of live-cell assays, using both traditional 2D techniques and advanced 3D cell culture models.
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