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Behavioral Intervention

ePVA Monitoring System for Head and Neck Cancer

N/A
Recruiting
Led By Janet H. Van Cleave, PhD, RN
Research Sponsored by The University of Texas Health Science Center, Houston
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individuals with histologically diagnosed head and neck cancer (HNC) undergoing curative radiation therapy with or without chemotherapy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 weeks after completing radiation therapy
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a digital monitoring system to help detect uncontrolled symptoms in patients with head and neck cancer and provide timely interventions.

Who is the study for?
This trial is for English or Spanish speaking individuals with confirmed head and neck cancer, undergoing curative radiation therapy, with or without chemotherapy. It's also for clinicians treating these patients. People who don't meet these specific criteria are excluded.
What is being tested?
The study tests the NYU Electronic Patient Visit Assessment (ePVA), a digital system for monitoring symptoms in real-time against usual care methods. The goal is to see if ePVA improves swallowing, taste, smell, and social functions after radiation therapy.
What are the potential side effects?
Since this trial involves patient-reported outcomes rather than medication or invasive procedures, there are no direct side effects from interventions like drugs or surgery. However, participants may experience discomfort when discussing sensitive health issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have head and neck cancer and am receiving radiation to cure it, with or without chemotherapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 weeks after completing radiation therapy
This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks after completing radiation therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Head and neck cancer (HNC) symptoms as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)
Secondary study objectives
Acute Care Services Use as assessed by number of acute care visits
Acute Care Services Use as assessed by number of days of using acute care
Health-Related Quality of Life (HRQoL) as assessed by the EORTC QLQ-C30 Quality of Life Questionnaire (QLQ)
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: NYU Electronic Patient Visit Assessment (ePVA) plus Usual CareExperimental Treatment2 Interventions
Group II: Usual CareActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Usual Care
1990
Completed Phase 4
~7700

Find a Location

Who is running the clinical trial?

Fox Chase Cancer CenterOTHER
234 Previous Clinical Trials
39,103 Total Patients Enrolled
New York University Langone Perlmutter Cancer CenterUNKNOWN
University of KansasOTHER
154 Previous Clinical Trials
331,432 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,958 Previous Clinical Trials
41,112,310 Total Patients Enrolled
The University of Texas Health Science Center, HoustonLead Sponsor
957 Previous Clinical Trials
347,582 Total Patients Enrolled
New York University Meyers College of NursingUNKNOWN
Janet H. Van Cleave, PhD, RNPrincipal InvestigatorThe University of Texas Health Science Center at Houston (UTHealth Houston)
~180 spots leftby Aug 2028