RecruitingNot ApplicableNCT05793151

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

A Stepped Wedge Cluster Randomized Trial Comparing a Navigation-Based Multilevel Intervention With Treatment as Usual to Improve Initiation of Timely Postoperative Radiation Therapy in Adults With Head and Neck Cancer

Sponsor

Medical University of South Carolina

Enrollment

532 participants

Start Date

Oct 30, 2023

Study Type

INTERVENTIONAL

Conditions

Head and Neck Cancer Head and Neck Squamous Cell Carcinoma Oral Cavity Cancer Oropharynx Cancer Larynx Cancer

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?

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a patient navigator — a dedicated support person — can help head and neck cancer patients start radiation therapy more quickly after surgery, compared to standard care. **You may be eligible if...** - You are 18 or older - You have been diagnosed with squamous cell carcinoma (a type of cancer) of the mouth, throat, voice box, or nearby areas - Your cancer is at an advanced local stage (stage T3-4 or involving multiple lymph nodes) - You are planning to have surgery with the goal of curing your cancer - You are expected to need radiation therapy after surgery (possibly with chemotherapy) - You speak or read English or Spanish **You may NOT be eligible if...** - You have previously had radiation therapy for head and neck cancer in a way that affects your current treatment needs - You have a severe mental illness that would prevent you from taking part - You have HPV-positive throat cancer at an early lymph node stage (cT1-2N1 with one small lymph node under 3 cm) - You have another untreated cancer that may affect your life expectancy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALENDURE

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.