Evaluating the Implementation and Impact of Navigator-delivered ePRO System
2 other identifiers
interventional
3,090
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started May 2021
Longer than P75 for not_applicable cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 10, 2020
CompletedFirst Posted
Study publicly available on registry
March 22, 2021
CompletedStudy Start
First participant enrolled
May 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedResults Posted
Study results publicly available
June 16, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2027
ExpectedJune 16, 2026
June 1, 2026
4.7 years
December 10, 2020
April 13, 2026
June 14, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Service Penetration
% of eligible patients enrolled
up to 3 months of starting a treatment for cancer
Secondary Outcomes (9)
Proportion of Alerts Closed Within 48 Hours
up to 48 hours
% of Patients Completing ≥1 ePRO Survey
up to 6 months
% of Expected ePRO Surveys Completed Per Patient
up to 6 months
% of Surveys Completed of Surveys Sent to Patient
up to 6 months
Symptom Trajectory
up to 3 months; up to 6 months
- +4 more secondary outcomes
Study Arms (1)
Patient Group
OTHERPatients from UAB/MCI enrolled
Interventions
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
Eligibility Criteria
You may qualify if:
- Patient Group:
- Age ≥18
- Cancer patients at participating institution
- Receipt of chemotherapy, targeted therapy, and immunotherapy at participating institution from 2019-2026.
You may not qualify if:
- \- Second opinion only at participating institution.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Alabama at Birminghamlead
- University of South Alabamacollaborator
- National Institute of Nursing Research (NINR)collaborator
Study Sites (1)
University of Alabama at Birmingham
Birmingham, Alabama, 35249, United States
Related Publications (1)
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.
PMID: 35459238DERIVED
MeSH Terms
Conditions
Results Point of Contact
- Title
- Gabrielle Rocque
- Organization
- University of Alabama at Birmingham
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine, Division of Hematology & Oncology; Division of Gerontology, Geriatrics, & Palliative Care
Study Record Dates
First Submitted
December 10, 2020
First Posted
March 22, 2021
Study Start
May 4, 2021
Primary Completion
December 31, 2025
Study Completion (Estimated)
February 28, 2027
Last Updated
June 16, 2026
Results First Posted
June 16, 2026
Record last verified: 2026-06