Recruiting

Observational Study

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06030011

Conditions

Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

NYU Electronic Patient Visit Assessment (ePVA)

Usual Care

Study Details

Brief summary:

The PI and the research team developed the New York University (NYU) Electronic Patient Visit Assessment (ePVA) for head and neck cancer (HNC) as a patient-reported outcome measure (PRO) for the early detection of uncontrolled symptoms. The ePVA is digital patient-reported symptom monitoring system, providing actionable information at point-of-care that enables clinicians to provide real-time interventions. The study aims to advance the science of cancer care delivery by testing the effectiveness of the ePVA as a digital patient-reported monitoring system for patients with HNC in real-world settings and identify implementation strategies that optimize the effectiveness of the ePVA in diverse rural and urban settings. The study hypothesis is that participants assigned to the ePVA arm will have better swallowing, taste and smell, and social function than participants assigned to usual care arm at 4 weeks after completing radiation therapy.

Conditions

Head and Neck Cancer

Study ID

NCT06030011

Start date

Jun 25, 2024

Status verified date

Jul, 2026

Completion date

Aug 31, 2028

Anticipated

Primary completion date

Aug 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria (Patient Participants):

  • Individuals with histologically diagnosed head and neck cancer (HNC) undergoing curative radiation therapy with or without chemotherapy
  • English or Spanish speaking

Inclusion Criteria (Clinician Participants):

  • Clinicians (i.e., physicians, nurses, dentists, physician assistants, social workers, nutritionists, speech swallow therapists) caring for patients with head and neck cancer at the participating institutions

Exclusion Criteria (Patient and Clinician Participants):

  • Any medical condition that could limit the participant's ability to provide informed consent and complete the questionnaires.

Study Design

Enrollment

270 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: NYU Electronic Patient Visit Assessment (ePVA) plus Usual Care

active comparator: Usual Care

Interventions

NYU Electronic Patient Visit Assessment (ePVA)

The NYU Electronic Patient Visit Assessment (ePVA) for head and neck cancer is a digital patient-reported symptom monitoring system, providing actionable information at point-of-care that enables clinicians to provide real-time interventions. Patients access the ePVA through a web link and complete the survey questions within 10 minutes on digital devices (e.g., smart phones, laptops, or digital devices provided by the clinic).

Usual Care

Usual care encompasses pre-treatment, on treatment, and post-treatment care. Pre-treatment care includes education of patients on the treatment plan. On-treatment care includes daily monitoring by a nurse in the radiation therapy (RT) department, weekly on-treatment visits with the RT nurse practitioner and radiation oncologist, and weekly visits with medical oncology nurse practitioners and medical oncologists for patients receiving RT plus chemotherapy. Post-treatment care includes follow-up visits with HNC clinicians (i.e., surgeon, medical oncologist, oral maxillofacial surgeons, and radiation oncologist) to assess the patient's cancer status and identify the patient's acute and long-term symptoms. The clinician's decisions on radiologic exams and referrals to appropriate specialist services, including dental care, are based on the patient's cancer status and symptoms.

Primary outcome measure

  • Head and neck cancer (HNC) symptoms as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ) [ Time Frame: 4 weeks after completing radiation therapy ]

Central Contacts and Locations

Central contacts

Janet H. Van Cleave, PhD, RN

(713) 500-2000Janet.H.VanCleave@uth.tmc.edu

Locations

University of Kansas Cancer Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Chris Lominska, MD

clominska@kumc.edu

NYU Langone Perlmutter Cancer Center

Recruiting

New York, New York, United States, 10016

Contacts

Kenneth Hu, MD

Kenneth.Hu@nyulangone.org

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Jul 6, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-07-06.