Comparing Two Surveillance Approaches for People Who Have Received Treatment for HPV-associated Head and Neck Cancer and Show No Signs of Disease

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Squamous Cell Carcinoma

Intervention / Treatment
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* Other: Standard surveillance
* Other: Telemedicine surveillance (tele-surveillance)
* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study design is a 1:1 randomized clinical trial.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard surveillance<br>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 | Other: Standard surveillance<br>* Participant coming to the clinic for in-person follow-up visits and having routine endoscopy and cancer imaging procedures as needed<br>Other: Questionnaires<br>* 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<br>|
| Experimental: Telemedicine surveillance (tele-surveillance)<br>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. | Other: Telemedicine surveillance (tele-surveillance)<br>* 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.<br>Other: Questionnaires<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival (PFS) | PFS will be defined as pathologic evidence of local or distant tumor progression or death from any cause. Patients | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Locoregional recurrence (LRR) | 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. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tele-Surveillance, Remote Symptom Monitoring, 21-347, HPV-associated Head and Neck Cancer