CancerNCT04809740
Evaluating the Implementation and Impact of Navigator-delivered ePRO System
A study testing Navigator-delivered Home ePRO in people with Cancer, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Navigator-delivered Home ePRO
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,090 participants
- Where
- 1 siteUnited States
- Study dates
- 4 May 2021to 28 Feb 2027
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patient Group:
- Age ≥18
- Cancer patients at participating institution
- Receipt of chemotherapy, targeted therapy, and immunotherapy at participating institution from 2019-2026.
Who cannot join
- Second opinion only at participating institution.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35249
About this study
Official title: Evaluating the Implementation and Impact of Navigator-delivered ePRO Home Symptom Monitoring and Management
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.
- Conditions
- Cancer
- Being tested
- Navigator-delivered Home ePRO
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Navigator-delivered Home ePROOther
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
| Study group | Role | What they receive |
|---|---|---|
| Patient Group | Other | Patients from UAB/MCI enrolled Receives: Other: Navigator-delivered Home ePRO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Service Penetration
% of eligible patients enrolled
Measured: up to 3 months of starting a treatment for cancer
Secondary outcomes (9)
Proportion of Alerts Closed Within 48 Hours
alerts are measured by abstracting alert data from the ePRO database
Measured: up to 48 hours
% of Patients Completing ≥1 ePRO Survey
ePRO surveys are abstracted from the electronic patient-reported outcome system
Measured: 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
Measured: up to 6 months
% of Surveys Completed of Surveys Sent to Patient
ePRO surveys are abstracted from the ePRO database including surveys completed
Measured: 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
Measured: 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)
Measured: up to 3 months, up to 6 months
Number of Hospitalizations
Proportion of patients hospitalized (abstracted from the EMR)
Measured: up to 3 months, up to 6 months
Number of ICU Visits
Proportion admitted to the ICU
Measured: up to 3 months, up to 6 months
Total Cost of Care
total costs sent by UAB to payers (abstracted from billing records)
Measured: up to 3 months, 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 posted22 Mar 2021
- Study start4 May 2021
- Primary completion31 Dec 2025
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,090 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- University of South Alabama, National Institute of Nursing Research (NINR)
- Responsible party
- Principal investigator, Gabrielle Rocque, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809740
- Sponsor's protocol ID
- IRB-300007406
- Other IDs
- 5R01NR019058
- Status last verified
- Jun 2026
- First submitted
- 10 Dec 2020
- Last updated
- 16 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rocque GB, Henderson NL, Dent DN, Padalkar TV, Hendrix E, Smith CS, Odom JN, Kaufmann T, Huang CS, McGowan C, Pierce JY, Basch EM, Smith JD, Stover AM. Barriers encountered and implementation strategies deployed to facilitate real-world remote symptom monitoring in patients receiving active cancer treatment. Front Health Serv. 2026 Aug 12;6:1875180. doi: 10.3389/frhs.2026.1875180. eCollection 2026.
PubMed 42656729Rocque 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 at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Implementation and Impact of Navigator-delivered ePRO Home Symptom Monitoring and Management
- ClinicalTrials.gov ID
- NCT04809740
- Acronym / sponsor ID
- IRB-300007406
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,090 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- University of South Alabama, National Institute of Nursing Research (NINR)
- Study start
- 4 May 2021 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 22 Mar 2021 (actual)
- Results
- Posted 16 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient Group | Other | Other: Navigator-delivered Home ePROPatients from UAB/MCI enrolled |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18
- Cancer patients at participating institution
- Receipt of chemotherapy, targeted therapy, and immunotherapy at participating institution from 2019-2026.
Key exclusion criteria (1 listed)
- Second opinion only at participating institution.
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 |
|---|---|---|
| Navigator-delivered Home ePROThe 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 | Other | Patient Group |
Primary outcome
Service Penetration
Time frame: up to 3 months of starting a treatment for cancer
% of eligible patients enrolled
9 secondary outcomes
Proportion of Alerts Closed Within 48 Hours
Time frame: up to 48 hours
% of Patients Completing ≥1 ePRO Survey
Time frame: up to 6 months
% of Expected ePRO Surveys Completed Per Patient
Time frame: up to 6 months
% of Surveys Completed of Surveys Sent to Patient
Time frame: up to 6 months
Symptom Trajectory
Time frame: up to 3 months; up to 6 months
Number of ED Visits
Time frame: up to 3 months, up to 6 months
Number of Hospitalizations
Time frame: up to 3 months, up to 6 months
Number of ICU Visits
Time frame: up to 3 months, up to 6 months
Total Cost of Care
Time frame: up to 3 months, up to 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42656729Rocque GB, Henderson NL, Dent DN, Padalkar TV, Hendrix E, Smith CS, Odom JN, Kaufmann T, Huang CS, McGowan C, Pierce JY, Basch EM, Smith JD, Stover AM. Barriers encountered and implementation strategies deployed to facilitate real-world remote symptom monitoring in patients receiving active cancer treatment. Front Health Serv. 2026 Aug 12;6:1875180. doi: 10.3389/frhs.2026.1875180. eCollection 2026.
- Derived from this study: PubMed 35459238Rocque 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.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Navigator-delivered Home ePRO in people with Cancer, run by University of Alabama at Birmingham at 1 site in United States.
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 4 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Yes. Results are posted in the registry (first posted 16 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Service Penetration (time frame: up to 3 months of starting a treatment for cancer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04809740, which also lists 2 linked publications.
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 16 Jun 2026.