Advanced Cancer Clinical Trial
Official title:
Developing and Testing a Web-based Tool to Engage Advanced Cancer Patients in Palliative Care (ēlos)
The investigators aim to introduce patients with advanced cancer to supportive care resources, including specialty palliative care, through a novel app called "ELOS" (stands for "extra layer of support) in a prospective cohort study. The investigators will compare participant acceptance of this new electronic tool to industry standards and follow ultimate referrals to outpatient palliative care compared to historical, matched controls.
The investigators will conduct a prospective cohort study to investigate usability of
implementing Ēlos across 50 advanced cancer patients within the Duke Cancer Institute and
University of North Carolina - Chapel Hill Cancer Center. The investigators will obtain a
Data Transfer Agreement prior to enrollment at the University of North Carolina. Usability
testing evaluates a technology system's capacity for practical implementation in the field
including logistical, social, financial, regulatory, and time considerations. The Usability
test will also build foundational data needed to design a future, multi-site controlled trial
evaluating the efficacy of Ēlos alongside exploring real-world implementation issues to
address prior to undertaking the larger trial.
To conduct the study, the investigators will consecutively approach two populations: adult
advanced cancer patients (defined as any Stage IV solid tumor malignancy, or Stage III
pancreas or lung cancer) in the GI, GU, and Thoracic Cancer Clinics with a diagnosis made in
the preceding eight weeks. The investigators will primarily evaluate usability through
evaluating subject-reported perceived usefulness. .
The investigators will also measure change in patient self-efficacy and change knowledge of
palliative care scores alongside obtaining baseline data on palliative care referral rates.
To evaluate perceived usefulness, the investigators will use the Perceived Usefulness Scale
and Ease of Use subscales of the System Usability Scale, common tools used in health
technology evaluations30 and a single item "I feel prepared for the palliative care visit".
Lastly, the investigators will measure subsequent referrals to palliative care, comparing the
Ēlos cohort with a non-intervention cohort. the investigators will compare three cohorts: 1).
Ēlos intervention cohort; 2). An age-, disease-, and stage-matched cohort of usual care
patients during the same time period as the intervention; and 3). A similarly-matched cohort
who received usual oncology care six months prior to the study. The latter control cohort
evaluates palliative care referral practices prior to any intervention taking place to reduce
contamination. The investigators will use these preliminary data on referral rates to
determine the effect sizes needed to calculate the sample sizes for an Alliance CCDR protocol
for a NCORP trial.
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