Back to resultsA 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)
Primary Purpose
Head and Neck Cancer
Status
Unknown status
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Electronic Patient Visit Assessment (ePVA)
Sponsored by
About this trial
This is an interventional other trial for Head and Neck Cancer
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Sites / Locations
- NYU Rory Meyers College of NursingRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Interventional: Electronic Patient Visit Assessment (ePVA)
Usual care
Arm Description
Participants diagnosed with head and neck cancer randomized to Electronic Patient Visit Assessment intervention
Participants diagnosed with head and neck cancer randomized to usual care.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in health-related quality of life
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
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04502797
Brief 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)
Acronym
ePVA
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)
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 8, 2020 (Actual)
Primary Completion Date
March 15, 2022 (Anticipated)
Study Completion Date
March 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
New York University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Other
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Interventional: Electronic Patient Visit Assessment (ePVA)
Arm Type
Experimental
Arm Description
Participants diagnosed with head and neck cancer randomized to Electronic Patient Visit Assessment intervention
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Participants diagnosed with head and neck cancer randomized to usual care.
Intervention Type
Behavioral
Intervention Name(s)
Electronic Patient Visit Assessment (ePVA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient completion of 6 out of 7 assessments
Description
This is defined as a binary yes/no variable as to whether a participant completed 6 out of 7 assessments.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Change in health-related quality of life
Description
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).
Time Frame
Baseline, week 4, week 12, week 24
Title
Change in pain severity
Description
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).
Time Frame
Baseline, Day 7, Day 21, Day 35
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janet VanCleave, PhD, RN
Phone
212 - 992 - 7340
Email
Janet.vancleave@nyu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet VanCleave, PhD, RN
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Rory Meyers College of Nursing
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janet VanCleave, PhD, RN
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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 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.
IPD Sharing 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.
IPD Sharing Access Criteria
Requests may be directed to janet.vancleave@nyu.edu
Learn more about this trial
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)
We'll reach out to this number within 24 hrs