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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Squamous Cell Carcinoma
- Sponsor
- Memorial Sloan Kettering Cancer Center
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Progression-Free Survival (PFS)
- Status
- Active, Not Recruiting
- Last Updated
- 9 months ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Progression-Free Survival (PFS)
Time Frame: 2 years
PFS will be defined as pathologic evidence of local or distant tumor progression or death from any cause. Patients
Secondary Outcomes
- Locoregional recurrence (LRR)(2 years)