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

Study Overview
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Brief Summary
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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? Does ENDURE decrease racial disparities in delays starting PORT relative to treatment as usual What are the mechanisms through which ENDURE reduces treatment delays?

Detailed Description
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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 (exploratory objective).

Official Title
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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

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

Intervention / Treatment
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* Behavioral: ENDURE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) clinical stage grouping III-IV (8th edition) for patients with SCC of the oral cavity, p16-negative oropharynx, hypopharynx, larynx, paranasal sinuses, and nasal cavity or AJCC clinical stage grouping III-IV (7th edition) for patients with p16-positive SCC of the oropharynx or unknown primary. No history of radiation therapy for treatment of HNSCC in the definitive or adjuvant settings.Plan to undergo surgery at a participating site Plan for curative intent surgery at one of the participating centers Plan for PORT (regardless of whether it is at the surgical center) with or without concurrent chemotherapy following curative intent surgery based on the expectation of at least one of the following adverse features on final pathologic evaluation: pT3 or pT4 primary, N1 or greater nodal disease, perineural invasion (PNI), or lymphovascular invasion (LVI). Exclusion Criteria: Inability to speak or write English Severe mental illness that would prevent trial participation Synchronous untreated malignancy expected to impact life expectancy

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Stepped Wedge Cluster Randomization
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ENDURE<br>ENDURE is a theoretically-informed, navigation-based, multilevel intervention targeting barriers to timely, equitable guideline-adherent PORT. | Behavioral: ENDURE<br>* 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.<br>|
| No Intervention: Treatment As Usual<br>Treatment as usual at each site consists of standard of care clinical practices | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PORT Delay | The initiation of PORT > 6 weeks (42 days) following definitive surgery for HNSCC. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time-to-PORT | The number of days from the date of definitive surgery for HNSCC to the date of initiation of PORT. | 4 months | 
| Pre-Surgical consultation with radiation oncology | Consultation with a treating radiation oncologist prior to definitive surgery for HNSCC. | 1 month | 
| Pre-radiation therapy dental extractions | The removal of indicated carious/non-restorable teeth prior to or during the surgery for HNSCC. | 1 month | 
| 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. | 3 months | 
| Time to postoperative appointment with radiation oncology | Time from definitive surgery to the attendance at an appointment with the treating radiation oncologist. | 3 months |