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Multi-Site Trial of Navigation vs Treatment as Usual to Improve Initiation of Timely Adjuvant Therapy

NCT05793151 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 532

Last updated 2025-12-11

No results posted yet for this study

Summary

The goal of this clinical trial is to compare the effectiveness of a navigation-based multilevel intervention (ENDURE) with treatment as usual (TAU) to improve the initiation of guideline-adherent postoperative radiation therapy among patients with head and neck cancer. The main questions the trial aims to answer are:

1. Does ENDURE improve initiation of timely PORT relative to treatment as usual?
2. What are the mechanisms through which ENDURE improves timeliness to treatment?
3. What are the barriers and facilitators to the implementation of ENDURE into routine clinical care?

Conditions

Interventions

BEHAVIORAL

ENDURE

ENDURE provides patient education through the ENDURE Patient Resource Guide and social support by linking patients to community resources (patient-level), standardizes discussions about expectations for PORT and clinical documentation to enhance communication and care coordination within and across interprofessional cancer teams (team-level), and implements referral tracking across fragmented health systems (organization-level). To facilitate care coordination, ENDURE modifies existing standard of care patient navigation (an evidence-based intervention that addresses barriers to timely cancer care) by adding PORT-focused navigation at three key care transitions: into the cancer care system; from inpatient to outpatient after surgery; and from the surgical team to the radiation oncology team.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Medical University of South Carolina

    lead OTHER

Principal Investigators

  • Evan M Graboyes, MD, MPH · Medical University of South Carolina

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-30
Primary Completion
2028-03-30
Completion
2028-03-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05793151 on ClinicalTrials.gov