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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Medical University of South Carolina
Study ID
NCT05793151
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • ENDURE — BEHAVIORAL
    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.

Study Details

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?

Key Dates

Start date
Oct 30, 2023
Status verified
Dec 2025
Primary completion
Mar 30, 2028
Completion
Mar 30, 2028

Study Design

Enrollment
532 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: ENDURE
    ENDURE is a theoretically-informed, navigation-based, multilevel intervention targeting barriers to timely, guideline-adherent PORT.
  • No Intervention: Treatment As Usual
    Treatment as usual at each site consists of standard of care clinical practices

Primary Outcome Measure

Initiation of Timely PORT [ Time Frame: 3 months ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Washington University in St. LouisSt LouisMissouri63110
Ryan Jackson, MD
[email protected]
314 362 8641
Duke University Medical CenterDurhamNorth Carolina27710
Russel R Kahmke, MD, MMCi
Medical University of South CarolinaCharlestonSouth Carolina29425
Evan Graboyes, M.D., MPH, FACS
[email protected]
(843) 792-0719
Baylor College of MedicineHoustonTexas77030
Vlad C Sandulache, MD, PhD

Find similar trials in St Louis, MO

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Washington University in St. Louis· St Louis, MODuke University Medical Center· Durham, NCMedical University of South Carolina· Charleston, SCBaylor College of Medicine· Houston, TX

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