Head and Neck CancerNCT06030011
Implementing the NYU Electronic Patient Visit Assessment (ePVA) for Head and Neck Cancer In Rural and Urban Populations
A study testing NYU Electronic Patient Visit Assessment (ePVA) in people with Head and Neck Cancer, run by The University of Texas Health Science Center, Houston at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- NYU Electronic Patient Visit Assessment (ePVA)
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 5 sitesUnited States
- Study dates
- 25 Jun 2024to 31 Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with histologically diagnosed head and neck cancer (HNC) undergoing curative radiation therapy with or without chemotherapy
- English or Spanish speaking
- 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
Who cannot join
- Any medical condition that could limit the participant's ability to provide informed consent and complete the questionnaires.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Not yet recruiting
UTHealth Houston Cizik School of Nursing
Houston, Texas, 77030
Janet H. Van Cleave, PhD, RN, Janet.H.VanCleave@uth.tmc.edu
- Recruiting
University of Kansas Cancer Center
Kansas City, Kansas, 66160
Chris Lominska, MD, clominska@kumc.edu
- Not yet recruiting
NYU Meyers College of Nursing
New York, New York, 10010
Abraham A. Brody, PhD, RN, ab.brody@nyu.edu
- Recruiting
NYU Langone Perlmutter Cancer Center
New York, New York, 10016
Kenneth Hu, MD, Kenneth.Hu@nyulangone.org
- Not yet recruiting
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Jessica Bauman, MD, Jessica.Bauman@fccc.edu
About this study
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.
- Conditions
- Head and Neck Cancer
- Being tested
- NYU Electronic Patient Visit Assessment (ePVA), Usual Care
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NYU Electronic Patient Visit Assessment (ePVA)Behavioural
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).
Usual CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| NYU Electronic Patient Visit Assessment (ePVA) plus Usual Care | Experimental | Not described Receives: Behavioral: NYU Electronic Patient Visit Assessment (ePVA); Behavioral: Usual Care |
| Usual Care | Active comparator | Not described Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Head and neck cancer (HNC) symptoms as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)
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.
Measured: 4 weeks after completing radiation therapy
Secondary outcomes (4)
Pain as assessed by EORTC QLQ-H&N35 Quality of Life Questionnaire (QLQ)
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.
Measured: 4 weeks after completing radiation therapy
Health-Related Quality of Life (HRQoL) as assessed by the EORTC QLQ-C30 Quality of Life Questionnaire (QLQ)
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.
Measured: 4 weeks after completing radiation therapy
Acute Care Services Use as assessed by number of acute care visits
Acute Care Services Use is the use of services delivered in acute care settings, such as feeding tube placements, emergency room visits, and hospitalizations.
Measured: 4 weeks after completing radiation therapy
Acute Care Services Use as assessed by number of days of using acute care
Acute Care Services Use is the use of services delivered in acute care settings, such as feeding tube placements, emergency room visits, and hospitalizations.
Measured: 4 weeks after completing radiation therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start25 Jun 2024
- Primary completion31 Aug 2028 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), New York University, Perlmutter New York University Cancer Center, University of Kansas, Fox Chase Cancer Center
- Responsible party
- Principal investigator, Janet Van Cleave, The University of Texas Health Science Center, Houston
- Investigators
- Janet H. Van Cleave, PhD, RN, Principal investigator, The University of Texas Health Science Center at Houston (UTHealth Houston)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030011
- Sponsor's protocol ID
- HSC-SN-23-0784
- Status last verified
- Jul 2026
- First submitted
- 1 Sep 2023
- Last updated
- 6 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Van Cleave JH, Brody AA, Schulman-Green D, Hu KS, Li Z, Johnson SB, Major VJ, Lominska CE, Bauman JR, Hanania AN, Tatlonghari GV, Tsikis M, Egleston BL. Implementing the NYU Electronic Patient Visit Assessment (ePVA)(c) for head and neck cancer in rural and urban populations: a study protocol for a type 1 hybrid effectiveness-implementation clinical trial. Trials. 2025 Dec 9;26(1):563. doi: 10.1186/s13063-025-09268-w.
PubMed 41366462
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing the NYU Electronic Patient Visit Assessment (ePVA) for Head and Neck Cancer In Rural and Urban Populations
- ClinicalTrials.gov ID
- NCT06030011
- Acronym / sponsor ID
- HSC-SN-23-0784
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), New York University, Perlmutter New York University Cancer Center, University of Kansas, Fox Chase Cancer Center
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 31 Aug 2028 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 8 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NYU Electronic Patient Visit Assessment (ePVA) plus Usual Care | Experimental | Behavioral: NYU Electronic Patient Visit Assessment (ePVA), Behavioral: Usual Care |
| Usual Care | Active comparator | Behavioral: Usual Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Individuals with histologically diagnosed head and neck cancer (HNC) undergoing curative radiation therapy with or without chemotherapy
- English or Spanish speaking
- 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
Key exclusion criteria (1 listed)
- Any medical condition that could limit the participant's ability to provide informed consent and complete the questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NYU 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). | Behavioural | NYU Electronic Patient Visit Assessment (ePVA) plus Usual Care |
| Usual CareUsual 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. | Behavioural | NYU Electronic Patient Visit Assessment (ePVA) plus Usual Care, Usual Care |
Primary outcome
Head and neck cancer (HNC) symptoms as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)
Time frame: 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.
4 secondary outcomes
Pain as assessed by EORTC QLQ-H&N35 Quality of Life Questionnaire (QLQ)
Time frame: 4 weeks after completing radiation therapy
Health-Related Quality of Life (HRQoL) as assessed by the EORTC QLQ-C30 Quality of Life Questionnaire (QLQ)
Time frame: 4 weeks after completing radiation therapy
Acute Care Services Use as assessed by number of acute care visits
Time frame: 4 weeks after completing radiation therapy
Acute Care Services Use as assessed by number of days of using acute care
Time frame: 4 weeks after completing radiation therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Derived from this study: PubMed 41366462Van Cleave JH, Brody AA, Schulman-Green D, Hu KS, Li Z, Johnson SB, Major VJ, Lominska CE, Bauman JR, Hanania AN, Tatlonghari GV, Tsikis M, Egleston BL. Implementing the NYU Electronic Patient Visit Assessment (ePVA)(c) for head and neck cancer in rural and urban populations: a study protocol for a type 1 hybrid effectiveness-implementation clinical trial. Trials. 2025 Dec 9;26(1):563. doi: 10.1186/s13063-025-09268-w.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Janet H. Van Cleave, PhD, RN principal investigator
The University of Texas Health Science Center at Houston (UTHealth Houston)
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NYU Electronic Patient Visit Assessment (ePVA) in people with Head and Neck Cancer, run by The University of Texas Health Science Center, Houston at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janet H. Van Cleave, PhD, RN ((713) 500-2000, Janet.H.VanCleave@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Head and neck cancer (HNC) symptoms as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ) (time frame: 4 weeks after completing radiation therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06030011, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.