Clinical trial NCT05359042: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Gastrointestinal Cancers
Gastrointestinal Cancer Metastatic
Keywords: Patient Reported Outcomes
Hospitalizations
Emergency Department Visits
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2022-05-03
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized 2:1 to intervention arm or the standard of care arm
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Proportion of patients who engaged with the ePRO tool
timeFrame: Up to 6 months
measure: Change in overall score of EQ-5D
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of chat modules completed
timeFrame: Up to 6 months
measure: Proportion of chats in which PRO-CTCAE was offered were completed.
timeFrame: Up to 6 months
measure: Change in EQ-5D scores over time
timeFrame: Up to 6 months
measure: Number of patient-reported symptoms
timeFrame: Up to 6 months
measure: Number of patient-reported symptoms that were severe and were escalated
timeFrame: Up to 6 months
measure: Mean change in pain score over time.
timeFrame: Up to 6 months
measure: Number of phone calls and secure messages
timeFrame: Up to 6 months
measure: Predictive value of ED Visit and/or hospital admission
timeFrame: Up to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Francisco
name: Wesley A Kidder, MD
role: PRINCIPAL_INVESTIGATOR
References: