Clinical trial · Interventional
Comparing Two Surveillance Approaches for People Who Have Received Treatment for HPV-associated Head and Neck Cancer and Show No Signs of Disease
Randomized Clinical Trial of Tele-Surveillance and Remote Symptom Monitoring Compared to Standard Surveillance for HPV-Associated Oropharynx Cancer With No Evidence of Disease on Post-Treatment Imaging
- 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)
The purpose of this study is to compare standard surveillance with telemedicine surveillance (tele-surveillance) and find out which surveillance approach is best for people with HPV-associated head and neck cancer who have no evidence of disease after treatment. The researches will look at how the two approaches affect participants' quality of life, health outcomes, and expenses (for example, costs of routine visits and procedures). They will also determine doctors' and patients' satisfaction with tele-surveillance.
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 |
|---|---|---|---|
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaires | Other | — | UNRESOLVED |
| Standard surveillance | Other | — | UNRESOLVED |
| Telemedicine surveillance (tele-surveillance) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard surveillance
- description
- This surveillance approach involves the participant coming to the clinic for in-person follow-up visits and having routine endoscopy and cancer imaging procedures as needed
- interventionNames
- Other: Standard surveillance
- Other: Questionnaires
- type
- EXPERIMENTAL
- label
- Telemedicine surveillance (tele-surveillance)
- description
- Tele-surveillance involves the participant staying at home while their healthcare providers follow their condition and give them the care they need. They can communicate with their healthcare team through face-to-face video conferencing on their desktop computer, laptop, smart phone, or tablet. They can also communicate with their healthcare team by phone.
- interventionNames
- Other: Telemedicine surveillance (tele-surveillance)
- Other: Questionnaires
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 * ECOG 0-3 * Pathologically (histologically or cytologically) diagnosis of HPV associated squamous cell carcinoma of the oropharynx (tonsil, base of tongue, or oropharyngeal walls) * No evidence of disease on post-treatment PET/CT within 9 months of completing radiation therapy. No evidence of disease is a consensus determination by the patient's radiation, medical, and surgical oncologist. If the first PET/CT is equivocal, then a second PET/CT can be obtained within 9 months of completing radiation therapy. * Post-treatment diagnostic imaging with either CT or MRI (recommended but not required) * Able to speak and read English fluently * Able to provide informed consent Exclusion Criteria: * Patients on clinical trials related to head and neck cancer that have protocol defined follow up activities * Incomplete response or recurrent disease on post-treatment PET/CT * Completion of radiation and chemotherapy more than 9 months ago
References
Publications (1)
- DERIVEDShang T, Raab G, Chen L, Yu Y, Shamseddine A, Riaz N, McBride SM, Gelblum D, Morris LG, Lee NY, Zakeri K. Impact of Surveillance Imaging in Patients With HPV-Associated Oropharyngeal Carcinoma Treated With Definitive Radiation and Chemotherapy. Am J Clin Oncol. 2025 Jan 1;48(1):28-33. doi: 10.1097/COC.0000000000001144. Epub 2024 Sep 25. PMID 39319705