Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Larynx Cancer, Oral Cavity Cancer, Oropharynx Cancer
Conditions
Brief 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?
Detailed description
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).
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.
Sponsors
National Cancer Institute (NCI)
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
Stepped Wedge Cluster Randomization
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Initiation of Timely PORT | 3 months | The initiation of PORT \> 6 weeks (42 days) following definitive surgery for HNSCC. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to postoperative scheduling with radiation oncology | 3 months | The time from definitive surgery to the placement of the postoperative referral (or follow-up appointment) with the treating radiation oncologist. |
| Time to postoperative appointment with radiation oncology | 3 months | Time from definitive surgery to the attendance at an appointment with the treating radiation oncologist. |
| Time-to-PORT | 4 months | 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 | 1 month | Consultation with a treating radiation oncologist prior to definitive surgery for HNSCC. |
| Pre-radiation therapy dental extractions | 1 month | The removal of indicated carious/non-restorable teeth prior to or during the surgery for HNSCC. |
Countries
United States
Contacts
Primary ContactEvan M Graboyes, MD, MPH
Outcome results
None listed