Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electronic Patient Visit Assessment (ePVA) | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Interventional: Electronic Patient Visit Assessment (ePVA)
- description
- Participants diagnosed with head and neck cancer randomized to Electronic Patient Visit Assessment intervention
- interventionNames
- Behavioral: Electronic Patient Visit Assessment (ePVA)
- type
- NO_INTERVENTION
- label
- Usual care
- description
- Participants diagnosed with head and neck cancer randomized to usual care.
Primary outcomes (1)
- measure
- Patient completion of 6 out of 7 assessments
- timeFrame
- 24 weeks
- description
- This is defined as a binary yes/no variable as to whether a participant completed 6 out of 7 assessments.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: To be eligible to participate in this study, an individual must meet all of the following criteria: 1. Histologically diagnosed HNC 2. Undergoing RT with or without chemotherapy, 3. English speaking, 4. aged 18 years or older. Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Unable to attend scheduled appointment due to geographical, social or mental reseaons, 2. 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).
References
Publications (0)
Data not yet available