Electronic Patient Reported Outcomes in Patients With Gastrointestinal Cancers

Gastrointestinal Cancers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05359042
• Other study ID #: 214511
• Secondary ID: NCI-2022-02553
• Status: Withdrawn
• Phase: N/A
• Start date: June 15, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Gastrointestinal Cancer Metastatic
• Gastrointestinal Cancers
• Gastrointestinal Neoplasms

Intervention

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.
• Health Related Quality of Life Surveys
Surveys will be administered to participants

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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