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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional: Electronic Patient Visit Assessment (ePVA) | Experimental | Participants diagnosed with head and neck cancer randomized to Electronic Patient Visit Assessment intervention |
|
| Usual care | No Intervention | Participants diagnosed with head and neck cancer randomized to usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Electronic Patient Visit Assessment (ePVA) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
To be eligible to participate in this study, an individual must meet all of the following criteria:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Janet VanCleave, PhD, RN | Contact | 212 - 992 - 7340 | Janet.vancleave@nyu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Janet VanCleave, PhD, RN | NYU Langone Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Rory Meyers College of Nursing | Recruiting | New York | New York | 10010 | United States |
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.
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
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|
| Baseline, week 4, week 12, week 24 |
| 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). | Baseline, Day 7, Day 21, Day 35 |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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