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).