Electronic Patient Reported Outcomes in Patients With Gastrointestinal Cancers

Electronic Patient Reported Outcomes in Patients With Gastrointestinal Cancers at Risk for Unplanned ED Visits and Hospitalizations

This is a randomized trial of patients with gastrointestinal (GI) cancers treated at University of California, San Francisco (UCSF) who are starting a new line of systemic therapy to evaluate the feasibility of electronic patient reported outcome (ePRO) platform.

PRIMARY OBJECTIVES:

I. To evaluate the feasibility of the ePRO platform by describing the proportion of participants who engage 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) by comparing the change in overall score of EuroQol five-dimensional Questionnaire (EQ-5D) index.

SECONDARY OBJECTIVES:

I. To evaluate the degree of engagement with virtual care chat as defined by the proportion of chat modules completed.

II. To measure the potential differences in health-related quality of life (HRQoL).

III. To describe the symptom experience of participants in the intervention arm.

IV. To evaluate the performance of clinical escalation rules and impact on clinic workflow and efficiency.

V. To prospectively validate a risk model predicting emergency department (ED) visits and admissions due to cancer 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. III. To compare concordance between participant self-reported and provider assigned Eastern Cooperative Oncology Group (ECOG) Performance Status.

Inclusion Criteria:

• Age 18 years and older
• Diagnosis of gastrointestinal cancers: esophageal, gastric, hepatocellular carcinoma, cholangiocarcinoma, pancreatic, neuroendocrine, small intestine, colorectal and anal cancers.
• Patients can have early stage or advanced cancer and will be starting treatment with new, standard of care infusion therapy regimen at UCSF.
• Ability to understand study procedures and to comply with them for the entire length of the study.
• No limit on prior lines of therapy.
• Access to smartphone, tablet, or computer with capability to use symptom tracking web site (must have mobile phone number or email address).
• Willing and able to provide written, signed informed consent in English.
• Ability of individual or legal guardian/representative to understand a written informed consent document, and the willingness to sign it.

Exclusion Criteria:

• Patients who have already started therapy prior to study enrollment.
• Patients who are receiving their treatment outside of UCSF.
• Participation in another clinical trial (therapeutic or non-therapeutic).
• Patients who are on therapy with oral oncolytics or combination therapy of oral oncolytics and infusional agents.
• Patients who are non-English speakers.