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

Medical University of South Carolina532 enrolled

Overview

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?

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 improving initiation of timely PORT (primary 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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

532

Conditions

Head and Neck Cancer

Interventions

ENDUREBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age \>/= 18 years 2. Squamous cell carcinoma (SCC) (or histologic variant) of the oral cavity, oropharynx, hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity 3. 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. 4. 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. 5. Plan for curative intent surgery at one of the participating centers 6. 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: 1. Inability to speak or read English or Spanish. 2. Severe mental illness that would prevent trial participation. 3. HPV-positive OPC or unknown primary SCC staged as cT1-2N1 with a single ipsilateral LN \< 3 cm 4. Synchronous untreated malignancy expected to impact life expectancy

Locations (4)

Washington University in St. Louis

St Louis, Missouri, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

RECRUITING

Baylor College of Medicine

Houston, Texas, United States

RECRUITING

Outcomes

Primary Outcomes

Initiation of Timely PORT

The initiation of PORT \> 6 weeks (42 days) following definitive surgery for HNSCC.

Time frame: 3 months

Secondary Outcomes

Time-to-PORT

The number of days from the date of definitive surgery for HNSCC to the date of initiation of PORT.

Time frame: 4 months

Pre-Surgical consultation with radiation oncology

Consultation with a treating radiation oncologist prior to definitive surgery for HNSCC.

Time frame: 1 month

Pre-radiation therapy dental extractions

The removal of indicated carious/non-restorable teeth prior to or during the surgery for HNSCC.

Time frame: 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.

Time frame: 3 months

Time to postoperative appointment with radiation oncology

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

Time frame: 3 months

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

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts