Electronic Patient Reported Outcomes in Patients With Gastrointestinal Cancers

University of California San Francisco (UCSF)

Status: Withdrawn

Conditions: Gastrointestinal Cancer Metastatic; Gastrointestinal Cancers

Treatments: Other: Health Related Quality of Life Surveys; Other: Electronic Patient Reported Outcomes platform

Study type: Interventional

Funder types: Other

Identifiers

NCT05359042

214511

NCI-2022-02553 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

ePRO Assessment Tool

Experimental group

Description:

Participants will receive either a text message or an email inviting them to engage in the health chat. Participant assessments including HRQOL and user experience will be administered via the platform. Participants will also be able to participate in short, interactive patient education modules related to the infusion and side effect management.

Treatment:

Other: Electronic Patient Reported Outcomes platform

Other: Health Related Quality of Life Surveys

Standard of Care

No Intervention group

Description:

Participants in the standard of care arm will report symptoms via standard of care messaging through UCSF MyChart or telephone calls throughout the study period, and complete standard of care HRQoL surveys.