Gastrointestinal Cancer Metastatic, Gastrointestinal Cancers
Conditions
Keywords
Patient Reported Outcomes, Hospitalizations, Emergency Department Visits
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.
Interventions
OTHERElectronic Patient Reported Outcomes platform
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.
OTHERHealth Related Quality of Life Surveys
Surveys will be administered to participants
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Patients will be randomized 2:1 to intervention arm or the standard of care arm
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients who engaged with the ePRO tool | Up to 6 months | 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 | 6 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in EQ-5D scores over time | Up to 6 months | 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 | Up to 6 months | 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 | Up to 6 months | Number of patient-reported symptoms that were categorized as severe and escalated will be reported by frequency of symptom. |
| Proportion of chat modules completed | Up to 6 months | 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. |
| Number of phone calls and secure messages | Up to 6 months | 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 | Up to 6 months | 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. |
| Mean change in pain score over time. | Up to 6 months | 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. |
| Proportion of chats in which PRO-CTCAE was offered were completed. | Up to 6 months | 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 |
Outcome results
None listed