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

NCT05048459 | Active Not Recruiting

• 1 other identifier: 21-347
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Squamous Cell Carcinoma

Keywords

Tele-Surveillance; Remote Symptom Monitoring; 21-347; HPV-associated Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Locoregional recurrence (LRR)

  2 years

Study Arms (2)

Standard surveillance

ACTIVE COMPARATOR

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; Other: Questionnaires

Telemedicine surveillance (tele-surveillance)

EXPERIMENTAL

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); Other: Questionnaires

Interventions

Standard surveillance OTHER

Participant coming to the clinic for in-person follow-up visits and having routine endoscopy and cancer imaging procedures as needed

Standard surveillance

Telemedicine surveillance (tele-surveillance) OTHER

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.

Telemedicine surveillance (tele-surveillance)

Questionnaires OTHER

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

Standard surveillance; Telemedicine surveillance (tele-surveillance)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065, United States

Location

Related Links

• Memorial Sloan Kettering Cancer Center

MeSH Terms

Conditions

Carcinoma, Squamous Cell; Head and Neck Neoplasms

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Nancy Lee, MD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study design is a 1:1 randomized clinical trial.

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 17, 2021
• Study Start: September 1, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 8, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)