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

Sponsor

Medical University of South Carolina (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05793151

Collaborator

(none)

484

Enrollment

Arms

50.9

Anticipated Duration (Months)

Study Details

Study Description

Brief 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?
What are the mechanisms through which ENDURE reduces treatment delays?
What are the barriers and facilitators to implementing ENDURE across diverse clinical settings?

Condition or Disease	Intervention/Treatment	Phase
Head and Neck Cancer Head and Neck Squamous Cell Carcinoma Oropharynx Cancer Oral Cavity Cancer Larynx Cancer	Behavioral: ENDURE	N/A

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 (secondary objective).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

484 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Intervention Model Description:

Stepped Wedge Cluster RandomizationStepped Wedge Cluster Randomization

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2024

Anticipated Primary Completion Date :

Mar 30, 2028

Anticipated Study Completion Date :

Mar 30, 2028

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: ENDURE

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

Behavioral: ENDURE

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.

No Intervention: Treatment As Usual

Treatment as usual at each site consists of standard of care clinical practices

Outcome Measures

Primary Outcome Measures

PORT Delay [3 months]
The initiation of PORT > 6 weeks (42 days) following definitive surgery for HNSCC.

Secondary Outcome Measures

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.
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Medical University of South Carolina

Investigators

Principal Investigator: Evan M Graboyes, MD, MPH, Medical University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Evan Graboyes, Associate Professor-Faculty, Medical University of South Carolina

ClinicalTrials.gov Identifier:

NCT05793151

Other Study ID Numbers:

Pro00123953

First Posted:

Mar 31, 2023

Last Update Posted:

Apr 5, 2023

Last Verified:

Apr 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Head and Neck Neoplasms

Squamous Cell Carcinoma of Head and Neck

Mouth Neoplasms

Oropharyngeal Neoplasms

Laryngeal Neoplasms

Study Results

No Results Posted as of Apr 5, 2023