A Feasibility Study to Evaluate The Effect of the Electronic Patient Visit Assessment On Pain and Quality of Life for Patients With Head and Neck Cancer (HNC)
ePVA
1 other identifier
interventional
30
1 country
1
Brief Summary
This randomized, non-blinded, phase 0/I study will assess the feasibility of conducting a large randomized clinical trial to evaluate the efficacy of the ePVA to improve pain management and HRQoL in HNC. Thirty participants undergoing radiation therapy (RT) (with or without chemotherapy) will be randomized to: 1) ePVA intervention or 2) usual care. The intervention consists of participants completing the ePVA every other week during radiation therapy (RT), then weeks 4, 12, and 24 after end of RT. Automated reports of ePVA data, including pain reports and patient-reports of pain medications, will be sent to providers to inform their clinical decisions.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1 head-and-neck-cancer
Started Oct 2020
Shorter than P25 for early_phase_1 head-and-neck-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 28, 2020
CompletedFirst Posted
Study publicly available on registry
August 6, 2020
CompletedStudy Start
First participant enrolled
October 8, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2022
CompletedMarch 3, 2021
March 1, 2021
1.4 years
July 28, 2020
March 1, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Patient completion of 6 out of 7 assessments
This is defined as a binary yes/no variable as to whether a participant completed 6 out of 7 assessments.
24 weeks
Secondary Outcomes (2)
Change in health-related quality of life
Baseline, week 4, week 12, week 24
Change in pain severity
Baseline, Day 7, Day 21, Day 35
Study Arms (2)
Interventional: Electronic Patient Visit Assessment (ePVA)
EXPERIMENTALParticipants diagnosed with head and neck cancer randomized to Electronic Patient Visit Assessment intervention
Usual care
NO INTERVENTIONParticipants diagnosed with head and neck cancer randomized to usual care.
Interventions
The ePVA is an mHealth clinical support tool. The ePVA consists of a patient-reported measure that focuses on symptoms common to HNC (i.e. pain, eye, ear, nasal, mouth, voice, fibrosis, edema, skin, gastrointestinal, fatigue, limitation in movement, sleep, breathing, difficulty eating or drinking, swallowing, communication, social activities, anxiety, depression, and daily activities). PROMIS® questionnaires (pain intensity 3a, fatigue 6a, sleep disturbance 6a, anxiety 6a, depression 6a) are embedded within the ePVA.
Eligibility Criteria
You may qualify if:
- To be eligible to participate in this study, an individual must meet all of the following criteria:
- Histologically diagnosed HNC
- Undergoing RT with or without chemotherapy,
- English speaking,
- aged 18 years or older.
You may not qualify if:
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Unable to attend scheduled appointment due to geographical, social or mental reseaons,
- In the opinion of the investigator, is unable or unlikely to comply fully with the study requirements or procedures for any reason (e.g. cognitve or physical impairment).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
NYU Rory Meyers College of Nursing
New York, New York, 10010, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janet VanCleave, PhD, RN
NYU Langone Health
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 28, 2020
First Posted
August 6, 2020
Study Start
October 8, 2020
Primary Completion
March 15, 2022
Study Completion
March 15, 2022
Last Updated
March 3, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health.
- Access Criteria
- Requests may be directed to janet.vancleave@nyu.edu
The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to janet.vancleave@nyu.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.