Electronic Patient Reported Outcomes in Patients With Gastrointestinal Cancers

May 6, 2024 updated by: University of California, San Francisco

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of patients who engaged with the ePRO tool
Time Frame: Up to 6 months
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
Time Frame: 6 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of chat modules completed
Time Frame: Up to 6 months
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.
Time Frame: Up to 6 months
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
Time Frame: Up to 6 months
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
Time Frame: Up to 6 months
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
Time Frame: Up to 6 months
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.
Time Frame: Up to 6 months
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
Time Frame: Up to 6 months
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
Time Frame: Up to 6 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, San Francisco

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Wesley A Kidder, MD, University of California, San Francisco

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 15, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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