Using a digital tool to monitor symptoms in head and neck cancer patients
Implementing the NYU Electronic Patient Visit Assessment (ePVA) for Head and Neck Cancer In Rural and Urban Populations
This study tests if a new digital tool that helps head and neck cancer patients report their symptoms during radiation therapy can improve their swallowing, taste, smell, and social life compared to standard care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 270 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 5 sites (Kansas City, Kansas and 4 other locations) |
| Trial ID | NCT06030011 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the New York University Electronic Patient Visit Assessment (ePVA), a digital system designed for real-time monitoring of symptoms in patients with head and neck cancer undergoing radiation therapy. The ePVA allows patients to report their symptoms, enabling clinicians to provide timely interventions. The study aims to compare outcomes between patients using the ePVA and those receiving usual care, focusing on improvements in swallowing, taste, smell, and social function four weeks post-treatment. It also seeks to identify strategies for implementing the ePVA effectively in both rural and urban healthcare settings.
Who should consider this trial
Good fit: Ideal candidates include individuals with histologically diagnosed head and neck cancer who are undergoing curative radiation therapy and can communicate in English or Spanish.
Not a fit: Patients with medical conditions that impair their ability to provide informed consent or complete questionnaires may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved symptom management and quality of life for head and neck cancer patients during and after treatment.
How similar studies have performed: Other studies have shown promise in using digital patient-reported outcomes for symptom management, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Kansas City, Kansas and 4 other locations
- University of Kansas Cancer Center — Kansas City, Kansas, United States (Recruiting)
- NYU Meyers College of Nursing — New York, New York, United States (Not_yet_recruiting)
- NYU Langone Perlmutter Cancer Center — New York, New York, United States (Recruiting)
- Fox Chase Cancer Center — Philadelphia, Pennsylvania, United States (Not_yet_recruiting)
- UTHealth Houston Cizik School of Nursing — Houston, Texas, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Janet H. Van Cleave, PhD, RN — The University of Texas Health Science Center at Houston (UTHealth Houston)
- Study coordinator: Janet H. Van Cleave, PhD, RN
- Email: Janet.H.VanCleave@uth.tmc.edu
- Phone: (713) 500-2000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.