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

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

NCT ID: NCT05793151

Condition: Head and Neck Cancer
Head and Neck Squamous Cell Carcinoma
Oropharynx Cancer
Oral Cavity Cancer
Larynx Cancer

Conditions: Official terms:
Head and Neck Neoplasms
Squamous Cell Carcinoma of Head and Neck
Mouth Neoplasms
Oropharyngeal Neoplasms
Laryngeal Neoplasms

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Sequential Assignment

Intervention model description: Stepped Wedge Cluster Randomization

Primary purpose: Health Services Research

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: ENDURE
Description: 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.
Arm group label: ENDURE

Summary: 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: 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).

Criteria for eligibility:
Criteria:
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) 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. 4. No history of radiation therapy for treatment of HNSCC in the definitive or adjuvant settings.Plan to undergo surgery at a participating site 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 write English 2. Severe mental illness that would prevent trial participation 3. Synchronous untreated malignancy expected to impact life expectancy

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Washington University in St. Louis

Address:
City: Saint Louis
Zip: 63110
Country: United States

Status: Recruiting

Contact:
Last name: Ryan Jackson, MD

Phone: 314-362-8641
Email: jackson.ryan@wustl.edu

Facility:
Name: Duke University Medical Center

Address:
City: Durham
Zip: 27710
Country: United States

Status: Recruiting

Contact:
Last name: Russel R Kahmke, MD, MMCi

Facility:
Name: Medical University of South Carolina

Address:
City: Charleston
Zip: 29425
Country: United States

Status: Recruiting

Contact:
Last name: Evan Graboyes, M.D., MPH, FACS

Phone: (843) 792-0719
Email: graboyes@musc.edu

Facility:
Name: Michael E DeBakey Veterans Affairs Medical Center

Address:
City: Houston
Zip: 77030
Country: United States

Status: Recruiting

Contact:
Last name: Vlad C Sandulache, MD, PhD

Start date: October 30, 2023

Completion date: March 30, 2028

Lead sponsor:
Agency: Medical University of South Carolina
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: Medical University of South Carolina

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05793151