Navigation-Based Multilevel Intervention with Treatment as Usual to Improve Initiation of Timely Postoperative Radiation Therapy in Adults with Locally Advanced Head and Neck Cancer, ENDURE Trial

Status: active

This clinical trial tests the Enhanced Navigation for Disparities and Untimely Radiation Therapy (ENDURE) navigation-based, multilevel intervention in combination with usual care to improve initiation of timely postoperative radiation therapy in adults with head and neck cancer that has spread to nearby tissue or lymph nodes (locally advanced). Head and neck cancer is associated with poor survival despite aggressive combinations of surgery, radiation, chemotherapy, and immunotherapy and is a disease with profound racial disparities in mortality; Black patients with head and neck cancer have an approximately 50% relative decrease in survival compared to White patients with head and neck cancer. Initiation of postoperative radiation therapy within 6-weeks of surgery is recommended by the National Comprehensive Cancer Network Guidelines and is the first and only Commission on Cancer approved quality metric for head and neck cancer. Delays starting radiation therapy are associated with a decrease in 5-year survival and increased risk of mortality. Unfortunately, delays starting radiation therapy affect approximately 50% of patients with head and neck cancer and nearly 70% of Black patients and are thus a key modifiable driver of poor survival and racial disparities in mortality. Information gained from this trial may allow researchers to determine whether an enhanced patient navigation-based intervention can improve initiation and decrease racial disparities in starting timely, guideline adherent radiation therapy following surgery for locally advanced head and neck cancer.

Inclusion Criteria

Age >= 18 years on the day of consent
Squamous cell carcinoma (SCC) (or histologic variant) of the oral cavity, oropharynx, hypopharynx, larynx, unknown primary, paranasal sinuses, or nasal cavity * In situations in which the patient fulfills all other inclusion criteria but the biopsy shows SCC in-situ or moderate/severe dysplasia but the patient is scheduled to undergo curative intent surgery due to clinical suspicion of invasive SCC, the diagnosis of SCC-in situ or moderate/severe dysplasia is sufficient to fulfill the pathologic diagnosis criterion
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
No history of radiation therapy for treatment of head and neck squamous cell carcinoma (HNSCC) in the definitive or adjuvant settings that would, at the discretion of the enrolling clinician, affect the patient’s need for adjuvant radiation therapy (RT)
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 * At the time of informed consent, plan for adjuvant therapy following curative intent surgery for HNSCC 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 read English or Spanish * For the purposes of this eligibility criterion, speaking refers to English or Spanish language fluency, not alterations of voice due to tracheotomy or laryngectomy status * For the purpose of reading English or Spanish, if the patient is able to participate in clinical care decisions and requires a legally authorized representative to sign the informed consent document for surgery due to inability to understand its written content, then that patient would not be eligible for the clinical trial
Severe mental illness that would prevent trial participation
Human papillomavirus (HPV)-positive oropharyngeal cancer (OPC) or unknown primary SCC staged as cT1-2N1 with a single ipsilateral LN < 3 cm
Synchronous untreated malignancy expected to impact life expectancy * Patients with known indolent malignancies (including but not limited to certain types of non-melanoma skin cancer, chronic lymphocytic leukemia, and micro-papillary thyroid carcinoma, etc.) who are clinically stable and undergoing active surveillance (i.e. do not require tumor-directed therapy) at the time of diagnosis are not excluded from the study
Participation in a therapeutic oncology trial does not preclude a potential patient from enrolling into ENDURE as long as the therapeutic trial does not impact any of the pre-specified ENDURE eligibility criteria

Additional locations may be listed on ClinicalTrials.gov for NCT05793151.

State:

United States

Missouri

Saint Louis

Washington University School of Medicine

Status: Active

Contact: Sidharth V Puram

Phone: 314-362-9943

Email: sidpuram@wustl.edu

North Carolina

Durham

Duke University Medical Center

Status: Active

Contact: Russel R. Kahmke

Phone: 919-629-1597

South Carolina

Charleston

Medical University of South Carolina

Status: Active

Contact: Evan M. Graboyes

Phone: 843-792-0719

Email: graboyes@musc.edu

Texas

Houston

Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center

Status: Active

Contact: Vlad C. Sandulache

Phone: 713-798-7218

Email: vlad.sandulache@bcm.edu

PRIMARY OBJECTIVE:

I. To evaluate the effectiveness of ENDURE compared with treatment as usual (TAU) on the initiation of timely, guideline-adherent postoperative radiation therapy (PORT) among patients with locally advanced head and neck squamous cell carcinoma (LAHNSCC) undergoing surgical therapy with a pathologic indication for PORT as measured by the proportion of patients who initiate PORT within 6 weeks of surgery.

SECONDARY OBJECTIVES:

I. To evaluate the effectiveness of ENDURE compared with TAU on the timely initiation of PORT among patients with LAHNSCC undergoing surgical therapy with a pathologic indication for PORT as determined by (1) time-to-PORT initiation following surgery and (2) treatment package time.

II. To assess the effectiveness of ENDURE compared with TAU on racial disparities in the initiation of timely guideline-adherent PORT among Black and White patients with LAHNSCC undergoing surgical therapy with a pathologic indication for PORT as determined by (1) the proportion of patients who initiate PORT within 6 weeks of surgery; (2) time-to-PORT initiation following surgery; and (3) treatment package time.

III. To examine the mechanism through which ENDURE reduces treatment delays compared with TAU as measured by key (1) processes of cancer care delivery.

EXPLORATORY OBJECTIVES:

I. To explore the mechanism through which ENDURE reduces treatment delays compared with TAU as measured by key health behavior constructs at the patient and team levels.

II. To explore the effect of ENDURE compared with TAU on resolving barriers to timely PORT as determined by (1) number of unresolved barriers and (2) proportion of unresolved barriers.

III. To explore the effect of ENDURE compared with TAU on satisfaction with cancer care.

IV. To characterize the implementation outcomes related to fidelity, adaptation, acceptability, appropriateness, and feasibility of ENDURE across diverse care delivery settings.

OUTLINE: Clinic sites are randomized to 1 of 4 arms in which they sequentially deliver TAU followed by ENDURE at a specified time-point.

ARM I (SEQUENCE 1): Patients undergo TAU which consists of discussions about the indications, risks/benefits/alternative, guidelines, timing, and logistical details of adjuvant therapy. These discussions will be administered according to practice patterns of the involved providers on study. At 12 months, sites transition to the ENDURE intervention and patients complete one-on-one, 30-60 minute PORT-focused navigation sessions at their pre-surgical consult, hospital discharge, and first post-operative clinic visit over 6-8 weeks on study. Through this navigation program, patients receive an ENDURE patient resource guide, travel support, standardized discussion with clinician about indication for PORT, personalized PORT care plan, and referrals to optimize adherence with care delivery processes associated with timely PORT on study.

ARM II (SEQUENCE 2): Patients undergo TAU which consists of discussions about the indications, risks/benefits/alternative, guidelines, timing, and logistical details of adjuvant therapy. These discussions will be administered according to practice patterns of the involved providers on study. At 18 months, sites transition to the ENDURE intervention and patients complete one-on-one, 30-60 minute PORT-focused navigation sessions at their pre-surgical consult, hospital discharge, and first post-operative clinic visit over 6-8 weeks on study. Through this navigation program, patients receive an ENDURE patient resource guide, travel support, standardized discussion with clinician about indication for PORT, personalized PORT care plan, and referrals to optimize adherence with care delivery processes associated with timely PORT on study.

ARM III (SEQUENCE 3): Patients undergo TAU which consists of discussions about the indications, risks/benefits/alternative, guidelines, timing, and logistical details of adjuvant therapy. These discussions will be administered according to practice patterns of the involved providers on study. At 28 months, sites transition to the ENDURE intervention and patients complete one-on-one, 30-60 minute PORT-focused navigation sessions at their pre-surgical consult, hospital discharge, and first post-operative clinic visit over 6-8 weeks on study. Through this navigation program, patients receive an ENDURE patient resource guide, travel support, standardized discussion with clinician about indication for PORT, personalized PORT care plan, and referrals to optimize adherence with care delivery processes associated with timely PORT on study.

ARM IV (SEQUENCE 4): Patients undergo TAU which consists of discussions about the indications, risks/benefits/alternative, guidelines, timing, and logistical details of adjuvant therapy. These discussions will be administered according to practice patterns of the involved providers on study. At 34 months, sites transition to the ENDURE intervention and patients complete one-on-one, 30-60 minute PORT-focused navigation sessions at their pre-surgical consult, hospital discharge, and first post-operative clinic visit over 6-8 weeks on study. Through this navigation program, patients receive an ENDURE patient resource guide, travel support, standardized discussion with clinician about indication for PORT, personalized PORT care plan, and referrals to optimize adherence with care delivery processes associated with timely PORT on study.

After completion of study intervention, patients are followed up at start of radiation therapy (10-12 weeks after enrollment), at completion of radiation therapy (4 months after enrollment), and at end of the study (16 months after enrollment).

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Navigation-Based Multilevel Intervention with Treatment as Usual to Improve Initiation of Timely Postoperative Radiation Therapy in Adults with Locally Advanced Head and Neck Cancer, ENDURE Trial

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