Weclome to CodeX's New Patient Voices Series!
CodeX recently talked with cancer patients, survivors, and advocates to hear their stories and learn more about their perspective through the cancer care coordination process. CodeX (Common Oncology Data Elements eXtensions) is a HL7 FHIR Accelerator, launched at the end of 2019, that is building a community to enable interoperable cancer data modeling and applications that lead to step-change improvements in cancer patient care and research.
How is the Standard of Care Defined?
“Everyone just said this is the standard of care!” Today, Desiree D. has no evidence of disease, but in 2017 she was diagnosed with stage 2b breast cancer at the age of 40. When trying to make decisions about her course of treatment, Desiree was repeatedly told by doctors that she was getting the standard of care. In reality, the “standard of care” is relatively loose terminology. When making treatment decisions, Desiree felt that the standard of care where she was living in Virginia meant something different than the standard of care in Massachusetts or the standard of care in Vermont.
Imagine if a chef could not make a soup because he only understood Portuguese and the soup’s instructions were in Hindi. The chef could look elsewhere and find a solution after further research; however, the lack of a common language has cost the chef time and the chef’s soup is not going to be the same as he wished. This scenario is harmless, but a similar and much more serious situation exists across healthcare systems. The healthcare industry remains significantly less standardized than other industries. This means that treatments for the same type of cancer might vary greatly by geographic location, cancer center, and even oncologist in part because healthcare data is not collected or shared in a standard manner.
Accessing Clinical Trials
Lack of standardization does not mean the healthcare system is completely ineffective at treating cancer. However, it does mean that many patients feel as though they haven’t been provided with the most effective or personalized options. I asked Desiree what treatment options she wished she knew about after her diagnosis, and she said, “I would’ve liked to have known about clinical trials immediately.” Clinical trials offer important options, and important sources of hope, for all patients—and even patients who have not experienced success via more traditional interventions. Clinical trials can help treat current patients, and lead to the discovery of more effective treatments for future patients. Unfortunately, fewer than 6% of American cancer patients are enrolled in clinical trials. Patients are unaware of potentially lifesaving and life improving clinical trials. Those who search for clinical trials struggle to match with one, because insufficient standardization of Electronic Health Record (EHR) data makes efficient matching of patients to promising clinical trials extremely difficult.
When Desiree was making decisions about her course of treatment, her oncologist assumed that she would not qualify for any clinical trials. However, Desiree did her own research and found the website BreastCancerTrials.org. The site has a search tool that takes in data from breast cancer patients and matches them with trials for which they may be eligible. Desiree used the search tool and matched with a clinical trial; despite being told by her oncologist that matching to a trial was impossible. Desiree believes that BreastCancerTrials.org’s work is so crucial, and even at times life-saving, that she is now a patient advocate and the Outreach & Operations Manager for the website.
Despite the hard work of patient advocates like Desiree, it can be challenging for patients to use existing search tools because of the lack of standardization in patient data and of the clinical trials’ enrollment criteria. To find the correct trial a patient needs to enter their health data, often drawn from multiple sources (and memory), into the search tool. According to Desiree, the most important data source when using the search tools at BreastCancerTrials.org is a pathology report. Pathology reports are confusing and difficult to interpret for many patients. Pathology reports and other health records are not written so patients can read them easily, instead, the records are written to provide information that researchers and providers find valuable. On top of the overwhelming confusion caused by complex health records, results come back from matching services in different formats and sometimes do not contain the specific data required for patients to understand how well they match to a trial. Sometimes, patients are able to use the search tool based upon input from their health record but are barraged with search results featuring hundreds of clinical trials.
Clinical Trial Awareness
Desiree wasn’t the only patient or patient advocate we spoke to who hadn’t heard about clinical trials from their primary oncologist. Lydia G., a lymphoma and thyroid cancer patient, explained how she didn’t hear about clinical trials, “It was not brought up by a medical provider, but it was something that I had looked into because I was trying to seek alternative types of [treatments].” Like almost all the patients I spoke with, Lydia’s doctors never suggested clinical trials to her, instead she had to communicate with non-profit patient advocacy groups to research clinical trial eligibility and availability.
To find out more on why patients aren’t recommended by providers for clinical trials, I spoke with Lee J., a patient advocate for the Southwest Oncology Group (SWOG). “Patient advocates suspect that if a trial is not being held or being sponsored at your institution where you’re going [for primary care], your doctor may not be interested in referring you for that trial [at another institution] because that may mean losing you to that institution. So, it’s not only knowing about the trial, but seeing if you can be on that trial locally or [have to] fly in to someplace [far away].”
Integrated Trial Matching
The CodeX use case project most focused on streamlining the clinical trial matching process is Integrated Trial Matching for Cancer Patients and Providers. This project leverages mCODE to help patients, providers, and trial matching services—like BreastCancerTrials.org—make the clinical trial matching process more efficient. Instead of tediously and manually entering information from a pathology report, a patient seamlessly matches to a trial by linking their EHR to the trial matching service. On the other hand, if a medical provider wishes to find the perfect clinical trial for their patient, then they quickly send the EHR mCODE data to the mCODE-enabled trial matching service to find the most promising trials.
Empower the System, Not Just the Patient
To learn more about how data standardization can directly benefit the lives of patients, I was referred by Christine K.—the principal investigator for the ICAREdata Patient Engagement Portal— to Patty S. Patty is the Chair of The Alliance for Clinical Trials in Oncology’s Patient Advocate Committee. According to Patty, empowering the healthcare system is just as important as empowering individual patients. “As a former scientist diagnosed with cancer, I had the tools and means to look and find clinical trials.” Even if some patients are empowered and can use search tools to comb through hundreds of clinical trials, not all patients have the tools or means to look for clinical trials or second opinions about available treatments.
Cancer diagnoses cause great trauma, shock, and confusion. Patients struggle to understand what options are available to them. Patty explained, everyone who is newly diagnosed does not know anything about their cancer or how it’s treated—regardless of their background. After diagnosis, patients are bombarded with information from doctors, but still do not fully understand what options they have. Lack of health literacy leads many patients who would qualify for clinical trials to not discover trials they qualify for—because they have never heard of clinical trials. Patty outlined her goal for the future, “I would like a system in which every patient is asked every time for every study (clinical trial) that they might qualify for—without any preconceived notion of whether they will say yes or no.”
