Head and Neck Cancer
Conditions
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.
Interventions
BEHAVIORALNYU 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).
BEHAVIORALUsual 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.
Sponsors
The University of Texas Health Science Center, Houston
National Cancer Institute (NCI)
New York University
Perlmutter New York University Cancer Center
University of Kansas
Fox Chase Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Head and neck cancer (HNC) symptoms as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ) | 4 weeks after completing radiation therapy | The EORTC QLQ-C30 and QLQ-H\&N35 will be used to measure head and neck cancer symptoms, such as social function, senses of taste and smell, and swallowing. The scores will be summed and then transformed to a single score ranging from 0=Best to 100=Worst. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain as assessed by EORTC QLQ-H&N35 Quality of Life Questionnaire (QLQ) | 4 weeks after completing radiation therapy | The EORTC QLQ-H\&N35 will be used to assess pain. The score will be summed and then transformed to a single score ranging from 0=Best to 100=Worst. |
| Health-Related Quality of Life (HRQoL) as assessed by the EORTC QLQ-C30 Quality of Life Questionnaire (QLQ) | 4 weeks after completing radiation therapy | The EORTC QLQ-H\&N35 will be used to assess Health-Related Quality of Life (HRQoL). The score will be summed and then transformed to a single score ranging from 0=Best to 100=Worst. |
| Acute Care Services Use as assessed by number of acute care visits | 4 weeks after completing radiation therapy | Acute Care Services Use is the use of services delivered in acute care settings, such as feeding tube placements, emergency room visits, and hospitalizations. |
| Acute Care Services Use as assessed by number of days of using acute care | 4 weeks after completing radiation therapy | Acute Care Services Use is the use of services delivered in acute care settings, such as feeding tube placements, emergency room visits, and hospitalizations. |
Countries
United States
Contacts
CONTACTJanet H. Van Cleave, PhD, RN
PRINCIPAL_INVESTIGATORJanet H. Van Cleave, PhD, RN
The University of Texas Health Science Center at Houston (UTHealth Houston)
Outcome results
None listed