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

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

Conditions: Squamous Cell Carcinoma

Treatments: Other: Questionnaires; Other: Telemedicine surveillance (tele-surveillance); Other: Standard surveillance

Study type: Interventional

Funder types: Other

Identifiers

NCT05048459

21-347

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Standard surveillance

Active Comparator group

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

Treatment:

Other: Standard surveillance

Other: Questionnaires

Telemedicine surveillance (tele-surveillance)

Experimental group

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.

Treatment:

Other: Telemedicine surveillance (tele-surveillance)

Other: Questionnaires