NCT05359042

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of California, San Francisco · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gastrointestinal Cancers
• Gastrointestinal Cancer Metastatic

Interventions

Type	Name	Description
OTHER	Electronic Patient Reported Outcomes platform	The ePRO tool is developed by a third-party vendor, Conversa, and engages the patient in a chat-based interaction to assess patient symptoms and provide educational material.
OTHER	Health Related Quality of Life Surveys	Surveys will be administered to participants

Timeline

• Start date: 2024-06-15
• Primary completion: 2024-12-30
• Completion: 2024-12-30
• First posted: 2022-05-03
• Last updated: 2024-05-08