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Electronic Health Reporting for Gastrointestinal Cancer

N/A

Waitlist Available

Led By Wesley A Kidder, MD

Research Sponsored by University of California, San Francisco

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years and older

Diagnosis of gastrointestinal cancers: esophageal, gastric, hepatocellular carcinoma, cholangiocarcinoma, pancreatic, neuroendocrine, small intestine, colorectal and anal cancers

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is testing whether an electronic platform for patients to report their outcomes is feasible for gastrointestinal cancer patients starting a new line of systemic therapy at UCSF.

Who is the study for?

This trial is for adults over 18 with any stage of gastrointestinal cancer who are about to start a new standard infusion therapy at UCSF. Participants must be able to understand and sign consent, have access to a smart device or computer for ePRO, and speak English. Those already on therapy, receiving treatment outside UCSF, taking oral cancer drugs, or in another trial can't join.Check my eligibility

What is being tested?

The study tests the use of an electronic platform where patients report their health-related quality of life while undergoing new systemic therapies for GI cancers. It's randomized, meaning participants are randomly assigned to either use the ePRO system or not during their treatment.See study design

What are the potential side effects?

Since this trial focuses on tracking patient-reported outcomes rather than testing a drug, there aren't direct side effects from interventions like you'd expect with medication trials.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with a type of gastrointestinal cancer.

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I can understand and am willing to sign the consent form.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in overall score of EQ-5D

Proportion of patients who engaged with the ePRO tool

Secondary outcome measures

Change in EQ-5D scores over time

Mean change in pain score over time.

Number of patient-reported symptoms

+5 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ePRO Assessment ToolExperimental Treatment2 Interventions

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.

Group II: Standard of CareActive Control1 Intervention

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor

2,500 Previous Clinical Trials

15,236,171 Total Patients Enrolled

Wesley A Kidder, MDPrincipal InvestigatorUniversity of California, San Francisco

Media Library

Health Related Quality of Life Surveys Clinical Trial Eligibility Overview. Trial Name: NCT05359042 — N/A

Gastrointestinal Cancer Research Study Groups: ePRO Assessment Tool, Standard of Care

Gastrointestinal Cancer Clinical Trial 2023: Health Related Quality of Life Surveys Highlights & Side Effects. Trial Name: NCT05359042 — N/A

Health Related Quality of Life Surveys 2023 Treatment Timeline for Medical Study. Trial Name: NCT05359042 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research project still taking on participants?

"Unfortunately, the information hosted on clinicaltrials.gov indicates that this particular trial is not currently enrolling patients. While first posted in December 1st, 2022 and last edited October 17th of the same year, there are 148 other trials actively recruiting participants right now."

Answered by AI

What are the expected results of this research endeavor?

"This clinical trial's primary outcome, which will be observed over a 6-month period, is the percentage of patients that interacted with the ePRO tool. Secondary objectives involve assessing changes in pain score (as defined by 0= No Pain to 10= Worst Pain) via linear mixed modelling and determining frequency of patient reported symptoms as well as proportion of chat modules completed per participant through point estimation and 95% binomial confidence intervals assuming normality assumptions are met."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Electronic Patient Reported Outcomes in Patients With Gastrointestinal Cancers

2024. "Electronic Patient Reported Outcomes in Patients With Gastrointestinal Cancers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05359042.