ePVA Monitoring System for Head and Neck Cancer

Recruiting in Palo Alto (17 mi)

+4 other locations

Overseen by Janet H. Van Cleave, PhD, RN

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Inability to consent, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the ePVA treatment for head and neck cancer?

The ePVA system helps patients with head and neck cancer by allowing them to report symptoms and limitations in real-time, which can lead to timely interventions and improve their quality of life. Studies show that using electronic patient-reported outcome tools like ePVA can improve patient satisfaction and help healthcare providers manage symptoms more effectively during treatment. ^{1 2 3 4 5}

Is the ePVA Monitoring System safe for use in humans?

The ePVA Monitoring System, used for tracking symptoms in head and neck cancer patients, has been studied for its feasibility and usefulness in clinical settings. While specific safety data is not detailed, the system is designed to improve patient care by helping manage symptoms, suggesting it is generally safe for use in humans. ^{1 4 5 6 7}

What makes the ePVA treatment unique for head and neck cancer?

The ePVA treatment is unique because it is a web-based tool that allows patients with head and neck cancer to report their symptoms and functional limitations in real-time, enabling early detection and intervention to improve their quality of life. ^{1 2 3 8 9}

Research Team

Janet H. Van Cleave, PhD, RN

Principal Investigator

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

Eligibility Criteria

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.

I speak English or Spanish.

Trial Timeline

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

Treatment Details

Interventions

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

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.

Participant Groups

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+

Dr. LaTanya Love

The University of Texas Health Science Center, Houston

Interim President

MD from UT Medical Branch in Galveston

Dr. Jagat Narula

The University of Texas Health Science Center, Houston

Chief Academic Officer since 2023

MD, PhD

Fox Chase Cancer Center

Collaborator

Trials

236

Recruited

39,300+

Dr. James Helstrom

Fox Chase Cancer Center

Chief Medical Officer since 2014

MD from University of Colorado School of Medicine, MBA from Washington University in St. Louis

Dr. Robert Uzzo

Fox Chase Cancer Center

Chief Executive Officer since 2022

MD from Cleveland Clinic, MBA

New York University Langone Perlmutter Cancer Center

Collaborator

Trials

1

Recruited

270+

University of Kansas

Collaborator

Trials

157

Recruited

332,000+

Lynne A. Bui

University of Kansas

Chief Medical Officer since 2017

MD from the David Geffen UCLA School of Medicine, BA in Molecular and Cell Biology from University of California, Berkeley

Randy Milby

University of Kansas

Chief Executive Officer since 2017

BS in Pharmacy from The University of Kansas, MBA in Finance/Marketing from Washington University in St. Louis – Olin Business School

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

New York University Meyers College of Nursing

Collaborator

Trials

1

Recruited

270+

Findings from Research

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 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]

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]

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]

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]

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 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]

References

1. China 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. [2022]

2. China pubmed.ncbi.nlm.nih.gov

The development, usability, and reliability of the Electronic Patient Visit Assessment (ePVA) for head and neck cancer. [2022]

3. United States 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. [2021]

4. United States 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. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Electronic patient-reported outcomes and toxicities during radiotherapy for head-and-neck cancer. [2023]

6. Japan pubmed.ncbi.nlm.nih.gov

[Electronic Reporting of PRO-CTCAE in Outpatients Receiving Chemotherapy-A Single-Center Feasibility Study]. [2022]

7. Canada 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. [2021]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Obtaining Patient-Reported Outcomes Electronically With "OncoFunction" in Head and Neck Cancer Patients During Aftercare. [2020]

9. England pubmed.ncbi.nlm.nih.gov

National Improvement of Waiting Times: First Results From the Dutch Head and Neck Audit. [2023]