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)
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|ClinicalTrials.gov Identifier: NCT04502797|
Recruitment Status : Unknown
Verified March 2021 by New York University.
Recruitment status was: Recruiting
First Posted : August 6, 2020
Last Update Posted : March 3, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Head and Neck Cancer||Behavioral: Electronic Patient Visit Assessment (ePVA)||Early Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Actual Study Start Date :||October 8, 2020|
|Estimated Primary Completion Date :||March 15, 2022|
|Estimated Study Completion Date :||March 15, 2022|
Experimental: Interventional: Electronic Patient Visit Assessment (ePVA)
Participants diagnosed with head and neck cancer randomized to Electronic Patient Visit Assessment intervention
Behavioral: Electronic Patient Visit Assessment (ePVA)
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.
No Intervention: Usual care
Participants diagnosed with head and neck cancer randomized to usual care.
- Patient completion of 6 out of 7 assessments [ Time Frame: 24 weeks ]This is defined as a binary yes/no variable as to whether a participant completed 6 out of 7 assessments.
- Change in health-related quality of life [ Time Frame: Baseline, week 4, week 12, week 24 ]Measured by EORTC QLQ-C30 global QoL/health scale, which consists of 30 questions, building five functional scales (physical, role, emotional, cognitive, social), a global QoL/health scale, symptom scales (fatigue, pain, nausea and vomiting, dyspnea, sleep disturbance, appetite loss, constipation and diarrhea) and perceived financial difficulties. The scale will be transformed to scores 0 to 100 (100 indicates best quality of life and 0 indicates least).
- Change in pain severity [ Time Frame: Baseline, Day 7, Day 21, Day 35 ]Measured by European Organization for Research and Treatment of Cancer (EORTC) QLQ-H&N-35 pain scale. The scale will be transformed to scores 0 to 100 (0 indicates least and 100 indicates most symptoms).
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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.
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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04502797
|Contact: Janet VanCleave, PhD, RN||212 - 992 - 7340||Janet.firstname.lastname@example.org|
|United States, New York|
|NYU Rory Meyers College of Nursing||Recruiting|
|New York, New York, United States, 10010|
|Contact: Janet VanCleave, PhD, RN|
|Principal Investigator:||Janet VanCleave, PhD, RN||NYU Langone Health|
|Responsible Party:||New York University|
|Other Study ID Numbers:||
|First Posted:||August 6, 2020 Key Record Dates|
|Last Update Posted:||March 3, 2021|
|Last Verified:||March 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Yes|
|Plan Description:||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 email@example.com. 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.|
Statistical Analysis Plan (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 firstname.lastname@example.org|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Head and Neck Neoplasms
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