Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04809740

Evaluating the Implementation and Impact of Navigator-delivered ePRO System

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Second opinion only at participating institution.

Treatment and study plan

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

Primary outcomes

  1. Service Penetration

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

    % of eligible patients enrolled

Secondary outcomes

  1. Proportion of Alerts Closed Within 48 Hours

    Time frame: up to 48 hours

    alerts are measured by abstracting alert data from the ePRO database

  2. % of Patients Completing ≥1 ePRO Survey

    Time frame: up to 6 months

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

  3. % of Expected ePRO Surveys Completed Per Patient

    Time frame: up to 6 months

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

  4. % of Surveys Completed of Surveys Sent to Patient

    Time frame: up to 6 months

    ePRO surveys are abstracted from the ePRO database including surveys completed

  5. Symptom Trajectory

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

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

  6. Number of ED Visits

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

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

  7. Number of Hospitalizations

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

    Proportion of patients hospitalized (abstracted from the EMR)

  8. Number of ICU Visits

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

    Proportion admitted to the ICU

  9. Total Cost of Care

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

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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute of Nursing Research (NINR)
  • University of South Alabama

Registry information

Official study title

Evaluating the Implementation and Impact of Navigator-delivered ePRO Home Symptom Monitoring and Management

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Mar 22, 2021
Registry last updated
Jun 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.