Electronic Patient Reported Outcomes in Patients With Gastrointestinal Cancers

NCT05359042 | Withdrawn

• 2 other identifiers: 214511NCI-2022-02553
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Gastrointestinal Cancers; Gastrointestinal Cancer Metastatic

Keywords

Patient Reported Outcomes; Hospitalizations; Emergency Department Visits

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (8)

• Proportion of chat modules completed

  Up to 6 months

• Proportion of chats in which PRO-CTCAE was offered were completed.

  Up to 6 months

• Change in EQ-5D scores over time

  Up to 6 months

• Number of patient-reported symptoms

  Up to 6 months

• Number of patient-reported symptoms that were severe and were escalated

  Up to 6 months

Study Arms (2)

ePRO Assessment Tool

EXPERIMENTAL

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; Other: Health Related Quality of Life Surveys

Standard of Care

NO 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.

Interventions

Electronic Patient Reported Outcomes platform OTHER

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.

Also known as: ePRO platform

ePRO Assessment Tool

Health Related Quality of Life Surveys OTHER

Surveys will be administered to participants

Also known as: HRQoL

ePRO Assessment Tool

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead

MeSH Terms

Conditions

Gastrointestinal Neoplasms

Interventions

Quality of Life

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases

Intervention Hierarchy (Ancestors)

Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• Wesley A Kidder, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized 2:1 to intervention arm or the standard of care arm

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: May 3, 2022
• Study Start: June 15, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 30, 2024
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share