CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 11 enrolled
Drug / intervention
Patient Navigationother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03821064
NCT03821064N/ACompleted

Single-arm, Phase II Study Evaluating the Clinical Impact of Navigation on Delays and Racial Disparities Starting Postoperative Radiation Therapy for Adults With Locally Advanced Head and Neck Cancer: The NDURE Study

Medical University of South Carolina·interventional·Posted Jan 29, 2019·Updated Feb 1, 2021

In Brief

A clinical study evaluating Patient Navigation for Cancer of Head and Neck. Completed, enrolled 11 participants across 1 site.

Detailed Summary

This study will evaluate whether a new patient navigation intervention can decrease delays starting post-operative radiation therapy after surgery for white and African-American head and neck cancer patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJan 29, 2019
Enrollment StartJun 3, 2019
Primary CompletionNov 21, 2019
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 7.4 years ago

Interventions

Patient Navigationother

NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (\~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.