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?
Age >/= 18 years
Squamous cell carcinoma (SCC) (or histologic variant) of the oral cavity, oropharynx, hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity
American Joint Committee on Cancer (AJCC) 8th edition clinical T3-4 or >N1 SCC of the oral cavity, oropharynx, hypopharynx, larynx, paranasal sinuses, nasal cavity, or unknown primary.
No history of radiation therapy for treatment of HNSCC in the definitive or adjuvant settings that would, at the discretion of the enrolling clinician, affect the patient's need for adjuvant RT.
Inability to speak or read English or Spanish.
Severe mental illness that would prevent trial participation.
HPV-positive OPC or unknown primary SCC staged as cT1-2N1 with a single ipsilateral LN < 3 cm
Synchronous untreated malignancy expected to impact life expectancy
Sequential
ENDURE
BehavioralENDURE 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.
Initiation of Timely PORT
The initiation of PORT \> 6 weeks (42 days) following definitive surgery for HNSCC.
Time-to-PORT
The number of days from the date of definitive surgery for HNSCC to the date of initiation of PORT.
Pre-Surgical consultation with radiation oncology
Consultation with a treating radiation oncologist prior to definitive surgery for HNSCC.
Pre-radiation therapy dental extractions
The removal of indicated carious/non-restorable teeth prior to or during the surgery for HNSCC.
Time to postoperative scheduling with radiation oncology
The time from definitive surgery to the placement of the postoperative referral (or follow-up appointment) with the treating radiation oncologist.
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Medical University of South Carolina
Lead sponsor
National Cancer Institute (NCI)
Collaborator
