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Electronic Patient Reported Outcomes in Patients With Gastrointestinal Cancers

Primary Purpose

Gastrointestinal Cancers, Gastrointestinal Cancer Metastatic

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Electronic Patient Reported Outcomes platform
Health Related Quality of Life Surveys
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Gastrointestinal Cancers focused on measuring Patient Reported Outcomes, Hospitalizations, Emergency Department Visits

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ePRO Assessment Tool

Standard of Care

Arm 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.

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.

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

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.
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
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.
Number of patient-reported symptoms
Number of patient-reported symptoms over the 6-month study period will be reported by frequency of symptom.
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.
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.
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.
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.

Full Information

First Posted
April 27, 2022
Last Updated
October 17, 2023
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT05359042
Brief Title
Electronic Patient Reported Outcomes in Patients With Gastrointestinal Cancers
Official Title
Electronic Patient Reported Outcomes in Patients With Gastrointestinal Cancers at Risk for Unplanned ED Visits and Hospitalizations
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 1, 2023 (Anticipated)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancers, Gastrointestinal Cancer Metastatic
Keywords
Patient Reported Outcomes, Hospitalizations, Emergency Department Visits

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized 2:1 to intervention arm or the standard of care arm
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ePRO Assessment Tool
Arm Type
Experimental
Arm 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.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm 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.
Intervention Type
Other
Intervention Name(s)
Electronic Patient Reported Outcomes platform
Other Intervention Name(s)
ePRO platform
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Health Related Quality of Life Surveys
Other Intervention Name(s)
HRQoL
Intervention Description
Surveys will be administered to participants
Primary Outcome Measure Information:
Title
Proportion of patients who engaged with the ePRO tool
Description
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.
Time Frame
Up to 6 months
Title
Change in overall score of EQ-5D
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Proportion of chat modules completed
Description
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.
Time Frame
Up to 6 months
Title
Proportion of chats in which PRO-CTCAE was offered were completed.
Description
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
Time Frame
Up to 6 months
Title
Change in EQ-5D scores over time
Description
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.
Time Frame
Up to 6 months
Title
Number of patient-reported symptoms
Description
Number of patient-reported symptoms over the 6-month study period will be reported by frequency of symptom.
Time Frame
Up to 6 months
Title
Number of patient-reported symptoms that were severe and were escalated
Description
Number of patient-reported symptoms that were categorized as severe and escalated will be reported by frequency of symptom.
Time Frame
Up to 6 months
Title
Mean change in pain score over time.
Description
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.
Time Frame
Up to 6 months
Title
Number of phone calls and secure messages
Description
The overall volume of phone calls and secure messages between each patient and the clinical team will be reported.
Time Frame
Up to 6 months
Title
Predictive value of ED Visit and/or hospital admission
Description
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.
Time Frame
Up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Banaz Shwan
Phone
877-827-3222
Email
Banaz.Shwan@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wesley A Kidder, MD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Banaz Shwan
Email
Banaz.Shwan@ucsf.edu
Phone
877-827-3222
Email
cancertrials@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Wesley A Kidder, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Electronic Patient Reported Outcomes in Patients With Gastrointestinal Cancers

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