Pancreatic cancer is an especially insidious form of cancer. According to Global Cancer Statistics 2020 (2020), the number of worldwide deaths (466,000) is almost high as the number of diagnoses (496,000).
A research initiative launched by Stand Up To Cancer (SU2C) and the Lustgarten Foundation for Pancreatic Research aims to bring those dire numbers down, through the development of novel approaches to treat and evaluate early pancreatic cancer. Ryan Nipp, an investigator on the SU2C–Lustgarten Foundation for Pancreatic Research Interception Research Team, spoke with Outsourcing-Pharma about the team’s goals, efforts, and accomplishments so far.
OSP: Could you please talk a little bit about how the COVID-19 pandemic impacted the way traditional trials (onsite) were conducted?
RN: In the initial days of the COVID pandemic, some clinical trials had to pause enrollment, delay opening, and alter the way patients presented for clinic visits. Additionally, some oncology clinics made changes to visitor policies, which resulted in patients not having their loved ones and/or family caregivers present in person for visits.
Importantly, to try to help avoid putting patients at risk for COVID, many cancer centers and oncology clinics saw increased use of telehealth and video visits to try to limit the need for in-person visits for patients.
OSP: Please share your perspective on how the pandemic impacted attitude toward and adoption of the decentralized clinical trials format.
RN: It would seem that the increased use of, and comfort with, telehealth has led to a change in attitudes from patients and clinicians toward the adoption of decentralized clinical trials. Notably, certain components of clinical trial enrollment and conduct may be more amenable to a decentralized design. For example, patients receiving care at community sites or different cancer centers may have access to certain clinical trials more feasibly if conducted via a decentralized format.
Additionally, clinician-to-clinician and patient-to-clinician communication about available trials and/or eligibility may be enhanced by a decentralized clinical trial design.
OSP: What about oncology trials—what sorts of changes did these studies undergo that might have been different from trials for other conditions?
RN: For oncology trials, in which patients may be at particularly high risk for poor outcomes related to COVID, many centers quickly adjusted the requirements for in-person visits and tried to adopt telehealth in order to avoid having high-risk patients being placed at risk for frequent visits to the hospital and/or clinics where they may encounter active COVID infections.
OSP: It’s widely accepted that clinical trials don’t reach people from certain communities (Black/Brown, rural, economically disadvantaged, etc.) equally. How can the decentralized clinical trials format level the playing field?
RN: The decentralized trials format could help reach patients from certain communities in several ways. First, the decentralized format could theoretically help patients and clinicians from certain communities have more ready access to information about the trials that are available as well as the ability to more quickly screen patients for eligibility and enrollment.
Second, decentralized trials may help remove the issue of frequent travel to academic cancer centers as a barrier to trial enrollment by allowing the increased use of telehealth to replace in-person visits, as well as helping with symptom monitoring and addressing treatment side effects remotely.
OSP: Could you please talk about some of the efforts SU2C has made to help increase decentralized clinical trial adoption, and to reduce inequities in research and care?
RN: SU2C is working towards bringing more clinical trials to where patients are, which is one way to achieve more equitable patient-centered care. By funding our team – the SU2C-Lustgarten Foundation For Pancreatic Research Interception Research Team – SU2C has invested in testing innovative strategies for delivering supportive oncology care at home.
Additionally, SU2C’s Health Equity Initiative is working to address critical needs in medically underserved communities by increasing diversity in SU2C-funded clinical trials, funding innovative research that addresses cancer inequities, and raising awareness for the importance of cancer screenings and clinical trials.
OSP: Could you please tell us about the important work being tackled by the SU2C–Lustgarten Foundation For Pancreatic Research Interception Research Team?
RN: Our SU2C-funded team at Massachusetts General Hospital has conducted a study of a novel intervention, called “Supportive Oncology Care at Home.” Patients received the Supportive Oncology Care at Home intervention while receiving neoadjuvant treatment of pancreas adenocarcinoma.
The intervention entailed the following:
- remote monitoring of daily patient-reported symptoms, daily vital signs, and weekly body weight
- a hospital in the home care model for symptom assessment and management
- structured communication with the oncology team.
With this pilot study, we demonstrated the feasibility and acceptability of a Supportive Oncology Care at Home intervention, which has led to additional research investigating the efficacy of this intervention for decreasing healthcare use and improving patient outcomes in a larger scale randomized trial.