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Active, not recruitingNCT04809740Updated Jun 16, 2026Results posted

Evaluating the Implementation and Impact of Navigator-delivered ePRO System

An interventional study of Navigator-delivered Home ePRO in Cancer, sponsored by University of Alabama at Birmingham. Active, not recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
3,090
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study summary

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.

Read the detailed description

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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Conditions studied

  • Cancer

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03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's enrollment of 3,090 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Patient Group:

  • Age ≥18
  • Cancer patients at participating institution
  • Receipt of chemotherapy, targeted therapy, and immunotherapy at participating institution from 2019-2026.

Exclusion criteria

Exclusion Criteria:

- Second opinion only at participating institution.

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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
3,090 participants (actual)

Study arms

  • Other
    Patient Group

    Patients from UAB/MCI enrolled

    Other: Navigator-delivered Home ePRO

Interventions

  • OtherNavigator-delivered Home ePRO

    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

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What researchers measure

Primary outcomes

  1. Service Penetration

    % of eligible patients enrolled

    Time frame: up to 3 months of starting a treatment for cancer

Secondary outcomes

  1. Proportion of Alerts Closed Within 48 Hours

    alerts are measured by abstracting alert data from the ePRO database

    Time frame: up to 48 hours

  2. % of Patients Completing ≥1 ePRO Survey

    ePRO surveys are abstracted from the electronic patient-reported outcome system

    Time frame: up to 6 months

  3. % of Expected ePRO Surveys Completed Per Patient

    ePRO surveys are abstracter from the database; the surveys completed are compared to those sent

    Time frame: up to 6 months

  4. % of Surveys Completed of Surveys Sent to Patient

    ePRO surveys are abstracted from the ePRO database including surveys completed

    Time frame: up to 6 months

  5. Symptom Trajectory

    abstract from ePRO database the symptom alerts; we will report the proportion alerting for the population over 6 months

    Time frame: up to 3 months; up to 6 months

  6. Number of ED Visits

    Proportion with patients with an ED visit (abstracted from the electronic medical record)

    Time frame: up to 3 months, up to 6 months

  7. Number of Hospitalizations

    Proportion of patients hospitalized (abstracted from the EMR)

    Time frame: up to 3 months, up to 6 months

  8. Number of ICU Visits

    Proportion admitted to the ICU

    Time frame: up to 3 months, up to 6 months

  9. Total Cost of Care

    total costs sent by UAB to payers (abstracted from billing records)

    Time frame: up to 3 months, up to 6 months

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Results

Posted Jun 16, 2026

Participant flow

Participant flow — Overall Study
MilestonePatients Enrolled in ePROs
Started3090
Completed3090
Not completed0

Outcome measures

PrimaryService Penetration

% of eligible patients enrolled

Time frame:
up to 3 months of starting a treatment for cancer
Reported as:
Count of participants · Participants
Service Penetration
ParticipantsPatient Group
Service Penetration3090
SecondaryProportion of Alerts Closed Within 48 Hours

alerts are measured by abstracting alert data from the ePRO database

Time frame:
up to 48 hours

Results for this outcome have not been posted.

Secondary% of Patients Completing ≥1 ePRO Survey

ePRO surveys are abstracted from the electronic patient-reported outcome system

Time frame:
up to 6 months

Results for this outcome have not been posted.

Secondary% of Expected ePRO Surveys Completed Per Patient

ePRO surveys are abstracter from the database; the surveys completed are compared to those sent

Time frame:
up to 6 months

Results for this outcome have not been posted.

Secondary% of Surveys Completed of Surveys Sent to Patient

ePRO surveys are abstracted from the ePRO database including surveys completed

Time frame:
up to 6 months

Results for this outcome have not been posted.

SecondarySymptom Trajectory

abstract from ePRO database the symptom alerts; we will report the proportion alerting for the population over 6 months

Time frame:
up to 3 months; up to 6 months

Results for this outcome have not been posted.

SecondaryNumber of ED Visits

Proportion with patients with an ED visit (abstracted from the electronic medical record)

Time frame:
up to 3 months, up to 6 months

Results for this outcome have not been posted.

SecondaryNumber of Hospitalizations

Proportion of patients hospitalized (abstracted from the EMR)

Time frame:
up to 3 months, up to 6 months

Results for this outcome have not been posted.

SecondaryNumber of ICU Visits

Proportion admitted to the ICU

Time frame:
up to 3 months, up to 6 months

Results for this outcome have not been posted.

SecondaryTotal Cost of Care

total costs sent by UAB to payers (abstracted from billing records)

Time frame:
up to 3 months, up to 6 months

Results for this outcome have not been posted.

Adverse events

Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Patient Group———

Baseline characteristics

All patients enrolled in remote symptom monitoring

Age, Categorical
Age, Categorical(Participants)Patient Group
<=18 years0
Between 18 and 65 years1669
>=65 years1421
Age, Continuous
Age, Continuous(years)Patient Group
Mean61 ± 13
Sex: Female, Male
Sex: Female, Male(Participants)Patient Group
Female1990
Male1100
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Patient Group
American Indian or Alaska Native3
Asian45
Native Hawaiian or Other Pacific Islander0
Black or African American803
White2097
More than one race30
Unknown or Not Reported112
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Patient Group
Hispanic or Latino56
Not Hispanic or Latino2239
Unknown or Not Reported795
Region of Enrollment
Region of Enrollment(Participants)Patient Group
United States3090
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Study locations

1 site
  • University of Alabama at Birmingham
    Birmingham, Alabama 35249, United States
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References and documents

Publications

  • 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. PubMed 35459238 ↗

Study documents

  • Protocol and statistical analysis plan · May 27, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 16, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04809740
Lead sponsor
University of Alabama at Birmingham
Collaborators
University of South Alabama, National Institute of Nursing Research (NINR)
Responsible party
Gabrielle Rocque (Associate Professor of Medicine, Division of Hematology & Oncology; Division of Gerontology, Geriatrics, & Palliative Care, University of Alabama at Birmingham) — Principal investigator
First posted
Mar 22, 2021
Start date
May 4, 2021
Primary completion
Dec 31, 2025
Completion
Feb 28, 2027 (estimated)
Results posted
Jun 16, 2026
Last update
Jun 16, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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