This clinical trial tests the usefulness of an electronic patient reported outcome (ePRO) platform in patients with gastrointestinal cancers who are at risk for unplanned emergency department visits and hospitalizations. An ePRO platform may allow patients to report symptoms and side effects when they occur. This may give doctors a more complete picture of how patients are doing. The purpose of this study is to learn about more ways to report physical and emotional symptoms related to cancer and its treatment to the patient's care team, and to learn how reporting these symptoms impacts the way oncology health care providers are able to respond.
Additional locations may be listed on ClinicalTrials.gov for NCT05359042.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To evaluate the feasibility of the ePRO platform by describing the proportion of patients who engages with the ePRO tool via virtual care chat at least once after enrollment.
II. To investigate the potential differences in health-related quality of life (HRQoL) over the study period of 6 months between the patients in the intervention and usual care arms.
SECONDARY OBJECTIVES:
I. To evaluate the degree of engagement with virtual care chat.
II. To measure the potential differences in health-related quality of life (HRQoL) via European Quality of Life Five Dimension Five Level Scale Questionnaire (EQ-5D) from enrollment to the completion of the study in the intervention and usual care arm.
III. To describe the symptom experience of patients on the intervention arm.
IV. To evaluate the performance of clinical escalation rules and impact on clinic workflow and efficiency for the clinical team.
V. To prospectively validate a risk model predicting emergency department (ED) visits and admissions due to treatment side effects.
EXPLORATORY OBJECTIVES:
I. To compare unplanned ED visits and hospitalizations between intervention arm and control arm.
II. To compare referral patterns to Symptom Management Clinic during the study period.
III. To compare concordance between patient self-reported and provider assigned Eastern Cooperative Oncology Group (ECOG) performance status.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP A: Patients report their symptoms for 6 months via standard of care messaging through MyChart or telephone calls.
GROUP B: Patients report their symptoms for 6 months via ePRO platform on days 4 and 7 after infusion of cycle 1, weekly, and 2 days before every scheduled visit with provider team.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationUniversity of California San Francisco
Principal InvestigatorWesley Allen Kidder