Gastrointestinal CancersNCT05359042
Electronic Patient Reported Outcomes in Patients With Gastrointestinal Cancers
A study testing Electronic Patient Reported Outcomes platform and Health Related Quality of Life Surveys in people with Gastrointestinal Cancers and Gastrointestinal Cancer Metastatic, run by University of California, San Francisco.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancers, Gastrointestinal Cancer Metastatic
- What is being tested?
- Electronic Patient Reported Outcomes platform and Health Related Quality of Life Surveys
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: Electronic Patient Reported Outcomes in Patients With Gastrointestinal Cancers at Risk for Unplanned ED Visits and Hospitalizations
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- To prospectively validate a risk model predicting emergency department (ED) visits and admissions due to cancer treatment side effects.
EXPLORATORY OBJECTIVES:
- 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.
- Being tested
- Electronic Patient Reported Outcomes platform, Health Related Quality of Life Surveys
- Keywords
- Patient Reported Outcomes, Hospitalizations, Emergency Department Visits
- Medical subject headings
- Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Patient Reported Outcomes platformOther
Also called ePRO 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.
Health Related Quality of Life SurveysOther
Also called HRQoL
Surveys will be administered to participants
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 6 months
Secondary outcomes (8)
Proportion of chat modules completed
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.
Measured: Up to 6 months
Proportion of chats in which PRO-CTCAE was offered were completed.
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
Measured: Up to 6 months
Change in EQ-5D scores over time
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.
Measured: Up to 6 months
Number of patient-reported symptoms
Number of patient-reported symptoms over the 6-month study period will be reported by frequency of symptom.
Measured: Up to 6 months
Number of patient-reported symptoms that were severe and were escalated
Number of patient-reported symptoms that were categorized as severe and escalated will be reported by frequency of symptom.
Measured: Up to 6 months
Mean change in pain score over time.
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.
Measured: Up to 6 months
Number of phone calls and secure messages
The overall volume of phone calls and secure messages between each patient and the clinical team will be reported.
Measured: Up to 6 months
Predictive value of ED Visit and/or hospital admission
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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2022
- Study start15 Jun 2024 (estimated)
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Why it stopped: Logistical constraints
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancersStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized 2:1 to intervention arm or the standard of care arm
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wesley A Kidder, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05359042
- Sponsor's protocol ID
- 214511
- Other IDs
- NCI-2022-02553
- Status last verified
- May 2024
- First submitted
- 27 Apr 2022
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Patient Reported Outcomes in Patients With Gastrointestinal Cancers at Risk for Unplanned ED Visits and Hospitalizations
- ClinicalTrials.gov ID
- NCT05359042
- Acronym / sponsor ID
- 214511
- Keywords
- Patient Reported Outcomes, Hospitalizations, Emergency Department Visits
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Logistical constraints
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- 15 Jun 2024 (estimated)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 3 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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.
- To prospectively validate a risk model predicting emergency department (ED) visits and admissions due to cancer treatment side effects.
EXPLORATORY OBJECTIVES:
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized 2:1 to intervention arm or the standard of care arm
| Arm | Type | Receives |
|---|---|---|
| ePRO Assessment Tool | Experimental | Other: Electronic Patient Reported Outcomes platform, Other: Health Related Quality of Life SurveysParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic Patient Reported Outcomes platformAlso: ePRO platformThe 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. | Other | ePRO Assessment Tool |
| Health Related Quality of Life SurveysAlso: HRQoLSurveys will be administered to participants | Other | ePRO Assessment Tool |
Primary outcome
Proportion of patients who engaged with the ePRO tool
Time frame: 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
Time frame: 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
8 secondary outcomes
Proportion of chat modules completed
Time frame: Up to 6 months
Proportion of chats in which PRO-CTCAE was offered were completed.
Time frame: Up to 6 months
Change in EQ-5D scores over time
Time frame: Up to 6 months
Number of patient-reported symptoms
Time frame: Up to 6 months
Number of patient-reported symptoms that were severe and were escalated
Time frame: Up to 6 months
Mean change in pain score over time.
Time frame: Up to 6 months
Number of phone calls and secure messages
Time frame: Up to 6 months
Predictive value of ED Visit and/or hospital admission
Time frame: Up to 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wesley A Kidder, MD principal investigator
University of California, San Francisco
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Patient Reported Outcomes platform and Health Related Quality of Life Surveys in people with Gastrointestinal Cancers and Gastrointestinal Cancer Metastatic, run by University of California, San Francisco.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who engaged with the ePRO tool (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2024.