Clinical Trials
Sponsor:
Sponsor Study ID:
Study 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 Locally Advanced Head and Neck Squamous Cell Carcinoma (The ENDURE Trial)
NCT Number:
NCT05793151
Phase:
N/A
Protocol Type:
Health Services Research
Age Group:
Adults
Disease Sites:
Larynx, Lip, Oral Cavity and Pharynx
Study Objectives:
Primary Objective:
1. To evaluate the effectiveness of ENDURE compared with TAU on the initiation of timely, guideline-adherent PORT among patients with 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:
1. 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) median time-to-PORT initiation following surgery and (2) treatment package time.
2. To assess the effectiveness of ENDURE compared with TAU on racial disparities in the timely initiation of 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) median time-to-PORT initiation following surgery; and (3) treatment package time.
3. To evaluate the effect of ENDURE compared with TAU on resolving barriers to timely PORT.
4. To compare the effect of ENDURE compared with TAU on satisfaction with cancer care as determined by Patient Satisfaction with Cancer Care scores.
5. To examine the mechanism through which ENDURE reduces treatment delays compared with TAU as measured by key (1) processes of cancer care delivery and (2) health behavior constructs at the patient and team levels.
6. To characterize the implementation outcomes related to fidelity, adaptation, acceptability, appropriateness, and feasibility of ENDURE across diverse care delivery settings.
Primary Endpoint:
PORT delay, defined per National Comprehensive Cancer Network (NCCN) Guidelines as the initiation of PORT > 6 weeks (42 days) following definitive surgery for HNSCC.
Select Secondary Endpoints:
Time-to-PORT initiation, defined as the number of days from the date of definitive surgery for HNSCC to the date of initiation of PORT.
Treatment package time, defined as the number of days from the date of definitive surgery for HNSCC to the date of PORT completion.
Patient Satisfaction with Cancer Care score.
Pre-surgical radiation consultation, defined as the attendance by the patient at a consultation with the treating radiation oncologist prior to surgery to discuss radiation therapy in the definitive or adjuvant setting.
Pre-radiation therapy dental extractions, defined as the extraction of indicated carious/non-restorable teeth prior to or during definitive surgery.
Time from surgery to PORT referral, defined as the time, in days, from the date of the definitive surgical procedure to the date the referral (or postoperative appointment) is placed to discuss adjuvant therapy with the treating radiation oncologist.
Time from PORT referral to appointment, defined as the time, in days, from the date of the definitive surgical procedure to the date that the patient attends a postoperative appointment with radiation oncology.
Study Documents
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