ePVA Monitoring System for Head and Neck Cancer

Recruiting at 4 trial locations

Overseen By Janet H. Van Cleave, PhD, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Inability to consent, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

270 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital tool called the ePVA (Electronic Patient Visit Assessment) to help individuals with head and neck cancer track their symptoms during treatment. The researchers aim to determine if the ePVA can improve swallowing, taste, smell, and social interactions compared to usual care methods four weeks after radiation therapy. Participants include those with head and neck cancer currently undergoing radiation therapy, with or without chemotherapy, who can speak English or Spanish. The tool could provide real-time feedback to doctors, aiding in more personalized care. As an unphased trial, this study offers an opportunity to contribute to innovative research that could enhance cancer care for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the ePVA monitoring system is safe for head and neck cancer patients?

Research has shown that the NYU Electronic Patient Visit Assessment (ePVA) helps patients with head and neck cancer report their symptoms and challenges. This system involves no drugs or physical treatments, so it avoids the usual side effects associated with them. Instead, it serves as a digital tool to enhance symptom tracking and management.

Other studies have used the ePVA to monitor symptoms like trouble swallowing and changes in taste or smell, enabling doctors to provide timely support. As a monitoring tool rather than a medical treatment, the ePVA has not been linked to any negative effects. Participants typically use it to report their symptoms, and it is generally well-received. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the NYU Electronic Patient Visit Assessment (ePVA) for head and neck cancer because it offers a fresh approach to monitoring and managing the condition. Unlike the usual care options that rely heavily on in-person check-ups and subjective reporting, ePVA provides a structured, electronic system to track patient symptoms and responses remotely. This potentially allows for more timely interventions and personalized care. The system aims to enhance communication between patients and healthcare providers, making it easier to catch complications early and adjust treatments as needed.

What evidence suggests that the ePVA monitoring system is effective for head and neck cancer?

Research has shown that the NYU Electronic Patient Visit Assessment (ePVA), which participants in this trial may receive alongside usual care, benefits patients with head and neck cancer. It enables patients to report symptoms online, assisting doctors in providing timely care. The ePVA aims to enhance patients' ability to eat, taste, smell, and socialize after radiation therapy. Studies suggest it effectively catches and addresses symptoms early, leading to better outcomes by ensuring patients receive appropriate care when needed. ^{1 6 7 8 9}

Who Is on the Research Team?

Janet H. Van Cleave, PhD, RN

Principal Investigator

The University of Texas Health Science Center at Houston (UTHealth Houston)

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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

I have head and neck cancer and am receiving radiation to cure it, with or without chemotherapy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Participants undergo radiation therapy as part of their standard treatment for head and neck cancer

6-8 weeks

ePVA Monitoring

Participants use the NYU Electronic Patient Visit Assessment (ePVA) for symptom monitoring and real-time interventions

4 weeks

Ongoing digital monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, focusing on symptoms like swallowing, taste, and smell

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• NYU Electronic Patient Visit Assessment (ePVA)
• Usual Care

Trial Overview 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.

How Is the Trial Designed?

Group I: NYU Electronic Patient Visit Assessment (ePVA) plus Usual Care Experimental Treatment 2 Interventions

Group II: Usual Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Fox Chase Cancer Center

Collaborator

Trials

236

Recruited

39,300+

New York University Langone Perlmutter Cancer Center

Collaborator

Trials

1

Recruited

270+

University of Kansas

Collaborator

Trials

157

Recruited

332,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

New York University Meyers College of Nursing

Collaborator

Trials

1

Recruited

270+

Published Research Related to This Trial

In a feasibility study involving 34 head and neck cancer patients undergoing radiation therapy, electronic patient-reported outcome (ePRO) surveys effectively identified 887 abnormal symptoms, all of which were addressed with documented interventions by the care team.

The use of ePROs was positively received by practitioners, indicating that integrating these tools into routine oncology practice can enhance symptom management and improve patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-World Use of Electronic Patient-Reported Outcome (ePRO) Tools Integrated in the Electronic Medical Record During Radiation Therapy for Head and Neck Cancer: Feasibility Study. Katzel, JA., Van Den Eeden, SK., Liu, R., et al.[2023]

The implementation of the electronic Patient-Reported Outcome Measure (PROM) 'OncoFunction' in head and neck cancer patients showed high feasibility, with 846 patients completing the PROM during 2,833 out of 3,610 visits (78.5%).

The latest version of 'OncoFunction' significantly reduced errors and time required for use, enhancing the efficiency of data collection and improving patient follow-up care by providing a comprehensive view of their health-related quality of life.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obtaining Patient-Reported Outcomes Electronically With "OncoFunction" in Head and Neck Cancer Patients During Aftercare. Zebralla, V., Müller, J., Wald, T., et al.[2020]

Between 2015 and 2021, waiting times for head and neck cancer treatment in the Netherlands improved significantly, with the median care pathway interval decreasing from 37 to 26 days and the time to treatment interval from 37 to 33 days.

The percentage of patients starting treatment within 30 days increased from 39% to 64% for the care pathway interval and from 35% to 40% for the time to treatment interval, indicating enhanced efficiency in cancer care delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National Improvement of Waiting Times: First Results From the Dutch Head and Neck Audit. van Oorschot, HD., de Jel, DVC., Hardillo, JA., et al.[2023]

In a study involving 40 patients with advanced cancers receiving chemotherapy, the use of electronically provided patient-reported outcomes (ePRO) revealed a significantly higher number of symptoms rated as ≥Grade 1 compared to evaluations by nurses, indicating that ePRO can detect more adverse events.

The study found that only a small percentage of symptoms were consistently detected by both ePRO and nurses, suggesting that ePRO could enhance the identification of adverse events in outpatient care, allowing for earlier intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Electronic Reporting of PRO-CTCAE in Outpatients Receiving Chemotherapy-A Single-Center Feasibility Study]. Naiki, Y., Kurosawa, S., Koike, K., et al.[2022]

In a study of 65 patients undergoing head-and-neck radiotherapy, significant declines in quality of life (QOL) were observed, particularly in fatigue, social activity, and overall QOL, with 70.8% of patients reporting these issues during treatment.

The study highlighted that concurrent chemoradiotherapy (CCRT) led to more severe adverse events, including grade 3 complications in 35.4% of patients, significant weight loss averaging 5.5 kg, and a high need for supportive care interventions like intravenous hydration and feeding tube placement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic patient-reported outcomes and toxicities during radiotherapy for head-and-neck cancer. Niska, JR., Halyard, MY., Tan, AD., et al.[2023]

The Electronic Patient Visit Assessment (ePVA) is a reliable and valid web-based tool that effectively captures patient-reported symptoms and functional limitations in individuals with head and neck cancer, demonstrating a high completion rate (92%) among participants.

The ePVA correlates significantly with health-related quality of life (HRQoL) scores, indicating that patients with more symptoms and limitations experience worse HRQoL, thus supporting its potential for real-time clinical interventions to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The usefulness of the Electronic Patient Visit Assessment (ePVA)© as a clinical support tool for real-time interventions in head and neck cancer. Van Cleave, JH., Fu, MR., Bennett, AV., et al.[2022]

The implementation of the Healthcare Monitor (HM) for head and neck cancer patients faced challenges, particularly in aligning the goals of clinicians, administrators, and IT staff, but it led to improved doctor-patient communication and consultation efficiency according to patient feedback.

While patients reported feeling better prepared and more focused on critical issues during consultations with HM, quantitative data did not show significant differences in outcomes compared to standard care, indicating a need for further research to fully assess HM's benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Keys to successful implementation of routine symptom monitoring in head and neck oncology with "Healthcare Monitor" and patients' perspectives of quality of care. Dronkers, EAC., Baatenburg de Jong, RJ., van der Poel, EF., et al.[2021]

The LogPAL mobile health app was found to be feasible and well-accepted among head and neck cancer survivors, with 87% of participants remaining in the study and a mean usability score of 71.9, indicating good user satisfaction.

Participants completed 73.2% of the questionnaires over the 8-week study period, suggesting that the app effectively engaged users in tracking and managing their post-treatment symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Mobile Patient-Facing App for Tracking Patient-Reported Outcomes in Head and Neck Cancer Survivors: Single-Arm Feasibility Study. Teckie, S., Solomon, J., Kadapa, K., et al.[2021]

The Electronic Patient Visit Assessment (ePVA) was developed to help head and neck cancer patients report 42 symptoms and 17 functional limitations, showing high usability with 90% of participants finding it easy to use and 80% expressing high satisfaction.

The ePVA demonstrated strong reliability (alpha = 0.82-0.85) and convergent validity, indicating that it effectively captures the impact of symptoms on quality of life, which is crucial for early detection and intervention in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The development, usability, and reliability of the Electronic Patient Visit Assessment (ePVA) for head and neck cancer. Van Cleave, JH., Fu, MR., Bennett, AV., et al.[2022]

Citations

1. trialx.com trialx.com/clinical-trials/listings/302274/implementing-the-nyu-electronic-patient-visit-assessment-epva-for-head-and-neck-cancer-in-rural-and-urban-populations/

Implementing the NYU Electronic Patient Visit Assessment ... 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 ...

2. trialfinder.panfoundation.org trialfinder.panfoundation.org/en-US/trial/listing/513815

Implementing the NYU Electronic Patient Visit Assessment ... The study aims to advance the science of cancer care delivery by testing the effectiveness of the ePVA as a digital patient-reported monitoring ...

3. mhealth.amegroups.org mhealth.amegroups.org/article/view/47482/html

The usefulness of the Electronic Patient Visit Assessment ... The ePVA may be a useful mHealth tool as a clinical support tool for real-time interventions for patient-reported symptoms and functional limitations in HNC.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1526590019301105

(114) The Electronic Patient Visit Assessment (ePVA) To test clinical usefulness of the ePVA, after informed consent, 72 participants with head and neck cancer completed the ePVA one time before, during, or after ...

5. reporter.nih.gov reporter.nih.gov/search/lzbDW5rRp0yTP2pKtmX-Hg/project-details/11142672

RePORT RePORTER - National Institutes of Health (NIH) | Implementing the NYU Electronic Patient Visit Assessment (ePVA) for Head and Neck Cancer In Rural and Urban Populations. Project Number5R01CA282149-03.

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06030011/implementing-the-nyu-electronic-patient-visit-assessment-epva-for-head-and-neck-cancer-in-rural-and-urban-populations

Implementing the NYU Electronic Patient Visit Assessment ... The PI and the research team developed the New York University (NYU) Electronic Patient Visit Assessment (ePVA) for head and neck cancer ...

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33634190/

The usefulness of the Electronic Patient Visit Assessment ... The usefulness of the Electronic Patient Visit Assessment (ePVA)© as a clinical support tool for real-time interventions in head and neck cancer.

8. withpower.com withpower.com/trial/phase-head-and-neck-neoplasms-2024-9053c

ePVA Monitoring System for Head and Neck Cancer The Electronic Patient Visit Assessment (ePVA) was developed to help head and neck cancer patients report 42 symptoms and 17 functional limitations, showing ...

9. trial.medpath.com trial.medpath.com/clinical-trial/da0e3d70d4ffadf9/nct06030011-nyu-electronic-patient-visit-assessment-head-neck-cancer

Implementing the NYU Electronic Patient Visit Assessment ... 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 ...