- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04809740
Evaluating the Implementation and Impact of Navigator-delivered ePRO System
May 17, 2023 updated by: Gabrielle Rocque, University of Alabama at Birmingham
Evaluating the Implementation and Impact of Navigator-delivered ePRO Home Symptom Monitoring and Management
1) Evaluate implementation of navigator-delivered Home ePRO for all cancer patients across multiple practice sites; 2) examine the barriers, facilitators, and implementation strategies used in implementing navigator-delivered Home ePRO; and 3) assess the impact of Home ePRO on clinical and utilization outcomes.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Randomized controlled trials by Basch (collaborator) and colleagues 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, investigators from two institutions will conduct a large-scale population-based implementation of an evidence-based Home ePRO intervention for all adult cancer patients receiving chemotherapy, including vulnerable populations such as African Americans, rural residents, and socioeconomically disadvantaged individuals.
This implementation will leverage infrastructure from Medicare's payment reform projects (Oncology Care Model, Oncology Care First Model), which require and financially support patient navigators, a natural workforce for Home ePRO implementation.
The investigators' hypothesis is that the deployed implementation strategies will result in successful navigator-delivered Home ePRO, which will improve both patient and health system outcomes.
Using the Consolidated Framework for Implementation Research (CFIR), this hypothesis will be tested using a hybrid type 2 design with three specific aims: 1) evaluate implementation of navigator-delivered Home ePRO for all cancer patients across multiple practice sites; 2) examine the barriers, facilitators, and implementation strategies used in implementing navigator-delivered Home ePRO; and 3) assess the impact of Home ePRO on clinical and utilization outcomes.
In Aim 1, Home ePRO will be evaluated using implementation outcomes (service penetrance, provider adoption/penetration, intervention fidelity).
In Aim 2, the investigators will gauge patient and healthcare team perceptions of barriers, facilitators of navigator-led Home ePRO, implementation strategies used to address these barriers, implementation strategy fidelity, and perception of implementation strategy ability to address barriers using an iterative qualitative analysis.
In Aim 3, patient-level outcomes (functional status, distress, depression, healthcare utilization, cost, survival) will be evaluated using real-world data sources.
The project is innovative because it will be the first study to evaluate real-world implementation of navigator-led Home ePRO for all cancer patients receiving chemotherapy, an approach that is both immediately scalable and sustainable within value-based payment models.
The proposed research is significant because it is expected to demonstrate successful implementation of navigator-delivered Home ePRO and effectiveness of the ePRO intervention on diverse patient populations.
Furthermore, the project will generate an implementation blueprint of successful implementation strategies that can be easily applied to other patient-reported outcomes, with the potential to positively impact patient care as health care transitions to a value-based system.
Study Type
Interventional
Enrollment (Anticipated)
7500
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Stacey A Ingram, MEd
- Phone Number: 205-934-6287
- Email: saadewakun@uabmc.edu
Study Contact Backup
- Name: Valerie M Lawhon, BS
- Phone Number: 205-934-9652
- Email: vlawhon@uabmc.edu
Study Locations
-
-
Alabama
-
Birmingham, Alabama, United States, 35249
- Recruiting
- University of Alabama at Birmingham
-
Contact:
- Stacey A Ingram, MEd
- Phone Number: 205-934-5287
- Email: saadewakun@uabmc.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Patient Group
7,500 Patients from UAB/MCI
|
evaluate implementation of navigator-delivered Home ePRO for all cancer patients across multiple practice sites; 2) examine the barriers, facilitators, and implementation strategies used in implementing navigator-delivered Home ePRO; and 3) assess the impact of Home ePRO on clinical and utilization outcomes
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Service Penetration
Time Frame: 5 years
|
% of eligible patients enrolled
|
5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 4, 2021
Primary Completion (Anticipated)
December 1, 2025
Study Completion (Anticipated)
January 1, 2026
Study Registration Dates
First Submitted
December 10, 2020
First Submitted That Met QC Criteria
March 18, 2021
First Posted (Actual)
March 22, 2021
Study Record Updates
Last Update Posted (Actual)
May 18, 2023
Last Update Submitted That Met QC Criteria
May 17, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- IRB-300007406
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cancer
-
Cellworks Group Inc.RecruitingCancer | Relapsed Cancer | Refractory CancerUnited States
-
University of Michigan Rogel Cancer CenterRecruitingCancer Liver | Cancer Brain | Cancer Head &Neck | Cancer PelvisUnited States
-
UNC Lineberger Comprehensive Cancer CenterHyundai Hope On WheelsRecruitingCancer | Pediatric Cancer | Survivorship | Cancer MetastaticUnited States
-
Vanderbilt-Ingram Cancer CenterNational Institutes of Health (NIH)Active, not recruitingAdvanced Cancer | Relapsed Cancer | Refractory CancerUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)CompletedStage III Pancreatic Cancer | Stage IIA Pancreatic Cancer | Stage IIB Pancreatic Cancer | Stage IV Gastric Cancer | Stage IVA Colorectal Cancer | Stage IVA Pancreatic Cancer | Stage IVB Colorectal Cancer | Stage IVB Pancreatic Cancer | Stage IIIA Gastric Cancer | Stage IIIB Gastric Cancer | Stage IIIC Gastric... and other conditionsUnited States
-
University of California, San FranciscoBristol-Myers Squibb; PfizerTerminatedStage IIIA Rectal Cancer | Stage IIIB Rectal Cancer | Stage IIIC Rectal Cancer | Metastatic Colorectal Adenocarcinoma | Metastatic Colon Adenocarcinoma | Metastatic Rectal Adenocarcinoma | Stage IIIA Colon Cancer | Stage IIIB Colon Cancer | Stage IIIC Colon Cancer | Stage IV Colon Cancer | Stage IV Rectal... and other conditionsUnited States
-
MiRXES Pte LtdRecruitingBreast Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Esophageal Cancer | Ovarian Cancer | Prostate Cancer | Thoracic Cancer | Liver CancerSingapore
-
Sidney Kimmel Cancer Center at Thomas Jefferson...CompletedStage I Breast Cancer | Stage I Uterine Corpus Cancer | Stage II Uterine Corpus Cancer | Stage III Uterine Corpus Cancer | Stage II Breast Cancer | Stage IIIA Breast Cancer | Stage IIIB Breast Cancer | Stage IA Breast Cancer | Stage IB Breast Cancer | Stage IIA Breast Cancer | Stage IIB Breast Cancer | Stage... and other conditionsUnited States
-
Massachusetts General HospitalNational Comprehensive Cancer NetworkCompletedGastric Cancer | Pancreatic Cancer | Esophageal Cancer | Rectal Cancer | Colon Cancer | Hepatobiliary CancerUnited States
-
Palleon Pharmaceuticals, Inc.RecruitingMelanoma | Cancer | Breast Cancer | Head and Neck Cancer | Gastric Cancer | Colorectal Cancer | Pancreatic Cancer | Ovarian Cancer | NSCLC | Non Small Cell Lung Cancer | Bladder Cancer | Colon Cancer | Urothelial Cancer | Oncology | CRC | Esophagogastric Junction Cancer | EGJUnited States
Clinical Trials on Evaluate implementation of navigator-delivered Home ePRO for all cancer patients
-
Eskisehir Osmangazi UniversityRecruiting
-
Sidekick HealthLandspitali University Hospital; Ljósið Cancer Rehabilitation CenterActive, not recruitingCancer | Colorectal Cancer | Lung Cancer | Prostate CancerIceland
-
The First Affiliated Hospital with Nanjing Medical...SIR RUNRUN HospitalRecruiting
-
Aalborg University HospitalKaren Elise Jensen Foundation; SENS Innovation Aps; Simon Fougners Hartmann Family... and other collaboratorsRecruitingQuality of Life | Telerehabilitation | COPD | Mobility LimitationDenmark
-
Consorzio OncotechCompleted
-
Memorial Sloan Kettering Cancer CenterThe City College of New York; Queens Cancer Center of Queens Hospital; New York... and other collaboratorsRecruitingAdvanced CancerUnited States
-
Hospices Civils de LyonCompleted
-
University Hospital, MontpellierUniversité Montpellier; Centre National de la Recherche Scientifique, France; Fondation pour la Recherche Médicale and other collaboratorsRecruiting
-
University of RochesterNational Cancer Institute (NCI); National Institutes of Health (NIH)CompletedCancer-related Cognitive DifficultiesUnited States
-
Fondazione Salvatore MaugeriUnknownAmyotrophic Lateral Sclerosis | Chronic Respiratory FailureItaly