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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01NR019058 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of South Alabama | OTHER |
| National Institute of Nursing Research (NINR) | NIH |
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Evaluate implementation of navigator-delivered Home ePRO for all cancer patients across multiple practice sites and assess the impact of Home ePRO on clinical and utilization outcomes.
Randomized controlled trials demonstrated that weekly electronic home-based PRO symptom monitoring with automated alerts to clinicians (Home ePRO) in cancer patients was associated with reduced healthcare utilization, improved quality of life, and increased overall survival. However, these trials were administered using infrastructure supported by research funding. A knowledge gap remains about optimal implementation strategies for and effectiveness of Home ePROs in real-world settings. To address this gap, we will conduct a large-scale population-based implementation of an evidence-based Home ePRO intervention for all adult cancer patients receiving chemotherapy. The investigators' hypothesis is that the implementation of navigator-delivered Home ePRO will be successful and will improve both patient and health system outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Group | Other | Patients from UAB/MCI enrolled |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Navigator-delivered Home ePRO | Other | The intervention includes standard of care weekly symptom survey delivery to patients, with alerts generated for symptoms that are sent to clinic nurses to address per standard of care protocol |
| Measure | Description | Time Frame |
|---|---|---|
| Service Penetration | % of eligible patients enrolled | up to 3 months of starting a treatment for cancer |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Alerts Closed Within 48 Hours | alerts are measured by abstracting alert data from the ePRO database | up to 48 hours |
| % of Patients Completing ≥1 ePRO Survey | ePRO surveys are abstracted from the electronic patient-reported outcome system |
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Inclusion Criteria:
Patient Group:
Exclusion Criteria:
- Second opinion only at participating institution.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35249 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35459238 | Derived | Rocque GB, Dionne-Odom JN, Stover AM, Daniel CL, Azuero A, Huang CS, Ingram SA, Franks JA, Caston NE, Dent AN, Basch EM, Jackson BE, Howell D, Weiner BJ, Pierce JY. Evaluating the implementation and impact of navigator-supported remote symptom monitoring and management: a protocol for a hybrid type 2 clinical trial. BMC Health Serv Res. 2022 Apr 22;22(1):538. doi: 10.1186/s12913-022-07914-6. |
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The primary outcome is service penetrance which is the proportion of patients who are eligible who are approached and enroll..
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients Enrolled in ePROs | Patients who are enrolled for ePROs at UAB/MCI |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
All patients enrolled in remote symptom monitoring
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient Group | Patients from UAB/MCI who are enrolled in remote symptom monitoring (Home ePRO) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Service Penetration | % of eligible patients enrolled | Posted | Count of Participants | Participants | up to 3 months of starting a treatment for cancer |
|
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We are not measuring mortality, other (not serious) adverse events, or serious adverse events within this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient Group | The population is the patients enrolled in remote symptom monitoring. Enrollment in remote symptom monitoring is done as part of standard of care. We did not measure mortality, other (not including serious) adverse events, serious adverse events, or mortality within this study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gabrielle Rocque | University of Alabama at Birmingham | 2059752914 | grocque@uabmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 27, 2025 | Jun 8, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| up to 6 months |
| % of Expected ePRO Surveys Completed Per Patient | ePRO surveys are abstracter from the database; the surveys completed are compared to those sent | up to 6 months |
| % of Surveys Completed of Surveys Sent to Patient | ePRO surveys are abstracted from the ePRO database including surveys completed | up to 6 months |
| Symptom Trajectory | abstract from ePRO database the symptom alerts; we will report the proportion alerting for the population over 6 months | up to 3 months; up to 6 months |
| Number of ED Visits | Proportion with patients with an ED visit (abstracted from the electronic medical record) | up to 3 months, up to 6 months |
| Number of Hospitalizations | Proportion of patients hospitalized (abstracted from the EMR) | up to 3 months, up to 6 months |
| Number of ICU Visits | Proportion admitted to the ICU | up to 3 months, up to 6 months |
| Total Cost of Care | total costs sent by UAB to payers (abstracted from billing records) | up to 3 months, up to 6 months |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
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| Secondary | Proportion of Alerts Closed Within 48 Hours | alerts are measured by abstracting alert data from the ePRO database | Not Posted | Dec 2026 | up to 48 hours | Participants |
| Secondary | % of Patients Completing ≥1 ePRO Survey | ePRO surveys are abstracted from the electronic patient-reported outcome system | Not Posted | Dec 2026 | up to 6 months | Participants |
| Secondary | % of Expected ePRO Surveys Completed Per Patient | ePRO surveys are abstracter from the database; the surveys completed are compared to those sent | Not Posted | Dec 2026 | up to 6 months | Participants |
| Secondary | % of Surveys Completed of Surveys Sent to Patient | ePRO surveys are abstracted from the ePRO database including surveys completed | Not Posted | Dec 2026 | up to 6 months | Participants |
| Secondary | Symptom Trajectory | abstract from ePRO database the symptom alerts; we will report the proportion alerting for the population over 6 months | Not Posted | Dec 2026 | up to 3 months; up to 6 months | Participants |
| Secondary | Number of ED Visits | Proportion with patients with an ED visit (abstracted from the electronic medical record) | Not Posted | Dec 2026 | up to 3 months, up to 6 months | Participants |
| Secondary | Number of Hospitalizations | Proportion of patients hospitalized (abstracted from the EMR) | Not Posted | Dec 2026 | up to 3 months, up to 6 months | Participants |
| Secondary | Number of ICU Visits | Proportion admitted to the ICU | Not Posted | Dec 2026 | up to 3 months, up to 6 months | Participants |
| Secondary | Total Cost of Care | total costs sent by UAB to payers (abstracted from billing records) | Not Posted | Dec 2026 | up to 3 months, up to 6 months | Participants |
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