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NCT05359042 | Not yet recruiting | Gastrointestinal Cancers


Electronic Patient Reported Outcomes in Patients With Gastrointestinal Cancers
Sponsor:

University of California, San Francisco

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.

Condition or disease

Gastrointestinal Cancers

Gastrointestinal Cancer Metastatic

Intervention/treatment

Electronic Patient Reported Outcomes platform

Health Related Quality of Life Surveys

Phase

Not Applicable

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 : Interventional
Estimated Enrollment : 300 participants
Masking : None (Open Label)
Primary Purpose : Health Services Research
Official Title : Electronic Patient Reported Outcomes in Patients With Gastrointestinal Cancers at Risk for Unplanned ED Visits and Hospitalizations
Actual Study Start Date : March 15, 2024
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2024
Arm Intervention/treatment

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

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.

Other: Health Related Quality of Life Surveys

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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.

Electronic Patient Reported Outcomes in Patients With Gastrointestinal Cancers

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Electronic Patient Reported Outcomes in Patients With Gastrointestinal Cancers

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Locations


Not yet recruiting

United States, California

University of California, San Francisco

San Francisco, California, United States, 94143

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