Squamous Cell Carcinoma
Conditions
Keywords
Tele-Surveillance, Remote Symptom Monitoring, 21-347, HPV-associated Head and Neck Cancer
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.
Interventions
OTHERStandard surveillance
Participant coming to the clinic for in-person follow-up visits and having routine endoscopy and cancer imaging procedures as needed
OTHERTelemedicine surveillance (tele-surveillance)
The tele-surveillance visit occurs annually after completion of therapy and consists of a phone call with or without video conferencing between the patient and the treatment team (physician, nurse, and/ or nurse practitioner). The use of video conferencing is strongly encouraged. Clinic visits, endoscopies, and imaging studies can be performed at the discretion of the treatment team for concerning patient symptoms.
OTHERQuestionnaires
EORTC QLQ-C30 and EORTC QLQ-HN43 at 12 and 24 months, FACE-Questionnaire Module, Telehealth Usability Questionnaire, Telehealth Usability Questionnaire, Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction -Patient Satisfaction inventory
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
The study design is a 1:1 randomized clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-Free Survival (PFS) | 2 years | PFS will be defined as pathologic evidence of local or distant tumor progression or death from any cause. Patients |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Locoregional recurrence (LRR) | 2 years | Any pathologic evidence of tumor progression in the head and neck will be counted as a LRR. Patients without concerning symptoms as determined by the treating physician at the time of the tele-visit will be determined to be free of LRR. If imaging or biopsies or ordered at any time and are consistent with tumor progression, then these patients will be counted as having a LRR event. both the EORTC QLQ-C30 and EORTC QLQ-HN43 Scores of all scales and single-item measures range from 0 to 100 with higher scores indicating better quality of life. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNancy Lee, MD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed