Multi-Site Trial of Navigation vs Treatment as Usual for Delays in Starting Adjuvant Therapy (ENDURE)

A Stepped Wedge Cluster Randomized Trial Comparing a Navigation-Based Multilevel Intervention With Treatment as Usual to Decrease Delays Starting Postoperative Radiation Therapy in Adults With Head and Neck Cancer

The goal of this clinical trial is to compare the effectiveness of a navigation-based multilevel intervention (ENDURE) with treatment as usual at decreasing delays starting guideline-adherent postoperative radiation therapy among patients with head and neck cancer. The main questions the trial aims to answer are: Does ENDURE decrease delays starting PORT relative to treatment as usual? What are the mechanisms through which ENDURE reduces treatment delays? What are the barriers and facilitators to implementing ENDURE across diverse clinical settings?

In this hybrid type 1 effectiveness-implementation study, the investigators will conduct a stepped-wedge cluster randomized trial with cancer centers (n=4; 484 patients) randomized to sequentially deliver treatment as usual (TAU) then ENDURE to patients with head and neck cancer undergoing surgery and postoperative radiation therapy (PORT). The trial will assess the effect of ENDURE vs TAU on delays starting PORT (primary objective), racial disparities in PORT delay (secondary objective), and the underlying mechanisms of ENDURE (secondary objective). The investigators will concurrently conduct a mixed-methods study with quantitative measures of implementation outcomes and qualitative data about implementation determinants from semi-structured interviews with key stakeholders and site visits (secondary objective).

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

ENDURE is a theoretically-informed, navigation-based, multilevel intervention targeting barriers to timely, equitable guideline-adherent PORT.

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.

The time from definitive surgery to the placement of the postoperative referral (or follow-up appointment) with the treating radiation oncologist.

Time from definitive surgery to the attendance at an appointment with the treating radiation oncologist.

Inclusion Criteria: Age >/= 18 years Diagnosis of locally advanced squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx, larynx, paranasal sinuses) Plan to undergo surgery at a participating site Plan to undergo postoperative radiation therapy (at the facilitating performing the surgery or elsewhere) Exclusion Criteria: History of radiation to the head and neck region Inability to speak or write English Cognitive impairment that precludes trial participation Synchronous untreated malignancy (patients with indolent malignancies; e.g., non-melanoma skin cancer, would not be excluded)

Below are the key elements of the data sharing plan as outlined in the NIH Policy for Data Management and Sharing: Research materials will include: (1) self-report measures from patients; (2) clinical data from the electronic medical record; (3) audio recordings and transcriptions of interviews from stakeholders; and (4) field notes from direct observations of the delivery of ENDURE at each site. Data will be raw or minimally processed. The investigators plan to use REDCap for data capture and management of the clinical and self-report measure data and NVivo for management of the qualitative data. REDCap data dictionaries can be distributed for reuse. The final data dictionaries have not been developed. Scientific data and metadata will be generated, preserved, and shared using NIH common data elements. Scientific data and metadata arising from the project will be uploaded to openICPSR, a self-publishing repository for social, behavioral, and health sciences research data.

Data will be shared no later than the time of a publication of findings of the trial's primary endpoint in a peer-reviewed journal.

All data sharing will comply with privacy and confidentiality protections such as the NIH Certificate of Confidentiality and applicable laws, regulations, and policies governing data derived from human participants.