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.

Study Overview

• Status: Withdrawn
• Conditions: Gastrointestinal Cancers; Gastrointestinal Cancer Metastatic
• Intervention / Treatment: Other: Electronic Patient Reported Outcomes platform; Other: Health Related Quality of Life Surveys

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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • University of California, San Francisco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ePRO Assessment Tool; 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.	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 Names: ePRO platform; Other: Health Related Quality of Life Surveys; Surveys will be administered to participants; Other Names: HRQoL
No Intervention: Standard of Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who engaged with the ePRO tool	The point estimation of proportion of patients who engaged with the ePRO tool via virtual care chat at least once after enrollment and its 95% binomial confidence interval (CI) will be obtained.	Up to 6 months
Change in overall score of EQ-5D	The EQ-5D is a standardized instrument for measuring generic health status. The health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents self-rate their level of severity for each dimension by selecting one of the following responses: no problems (0), slight problems (1), mild problems (2), moderate problems (3), or severe problems (4) with a particular dimension. Lower scores indicate less issues/problems with that particular health dimension. Change in overall score of EQ-5D index between the intervention and usual of care arms between baseline and 6 months will be reported	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of chat modules completed	To evaluate the degree of engagement with virtual care chat as defined by the proportion of chat modules completed per patient. Point estimation and 95% binomial CI will be obtained assuming normality assumption holds.	Up to 6 months
Proportion of chats in which PRO-CTCAE was offered were completed.	To evaluate the degree of engagement with virtual care chat as defined by the proportion of chats in which PRO-CTCAE was offered were completed. Point estimation and 95% binomial CI will be obtained assuming normality assumption holds	Up to 6 months
Change in EQ-5D scores over time	The EQ-5D is a standardized instrument for measuring generic health status. The health status is measured in terms of five dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The respondents self-rate their level of severity for each dimension by selecting one of the following responses: no problems (0), slight problems (1), mild problems (2), moderate problems (3), or severe problems (4) with a particular dimension. Lower scores indicate less issues/problems with that particular health dimension. Change in overall score of EQ-5D index between the intervention and usual of care arms between baseline, every 3 months, and at the completion of the study will be examined using a linear mixed model.	Up to 6 months
Number of patient-reported symptoms	Number of patient-reported symptoms over the 6-month study period will be reported by frequency of symptom.	Up to 6 months
Number of patient-reported symptoms that were severe and were escalated	Number of patient-reported symptoms that were categorized as severe and escalated will be reported by frequency of symptom.	Up to 6 months
Mean change in pain score over time.	The pain score will be obtained using a standard pain index with values ranging from 0= No Pain to 10= Worst pain as reported by patients. Higher scores indicate a greater degree of patient reported pain. The change in pain scores will be evaluated using a linear mixed model.	Up to 6 months
Number of phone calls and secure messages	The overall volume of phone calls and secure messages between each patient and the clinical team will be reported.	Up to 6 months
Predictive value of ED Visit and/or hospital admission	To prospectively validate a risk model predicting ED visits and admissions due to treatment side effects via Model area under the receiver operating characteristic (AUROC). Accuracy of a previously developed model will be prospectively assessed during the course of this study. The model currently generates an assessment of risk that a patient will have an Chemotherapy Measure (OP-35) qualifying event in the 30-day period following an infusional therapy administration. An OP-35 event is defined as: One or more inpatient admissions for anemia, dehydration, diarrhea, emesis, fever, nausea, neutropenia, pain, pneumonia, or sepsis within 30 days of chemotherapy treatment.	Up to 6 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Investigators: Principal Investigator: Wesley A Kidder, MD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2024
• Primary Completion (Estimated): December 30, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: April 27, 2022
• First Submitted That Met QC Criteria: April 27, 2022
• First Posted (Actual): May 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2024
• Last Update Submitted That Met QC Criteria: May 6, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Emergency Department Visits; Patient Reported Outcomes; Hospitalizations
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Gastrointestinal Diseases; Gastrointestinal Neoplasms
• Other Study ID Numbers: 214511; NCI-2022-02553 (Registry Identifier: NCI Clinical Trials Reporting Program (CTRP))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No