NCT04809740

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,701

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started May 2021

Longer than P75 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 22, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

May 4, 2021

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

4.7 years

First QC Date

December 10, 2020

Last Update Submit

March 30, 2026

Conditions

Cancer

Outcome Measures

Primary Outcomes (1)

  • Service Penetration

    % of eligible patients enrolled

    5 years

Study Arms (1)

Patient Group

OTHER

7,500 Patients from UAB/MCI

Other: Evaluate implementation of navigator-delivered Home ePRO for all cancer patients

Interventions

Evaluate implementation of navigator-delivered Home ePRO for all cancer patientsOTHER

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

Patient Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35249, United States

Location

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

Neoplasms

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

January 31, 2026

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

US(1)