Comparing Two Surveillance Approaches for People Who Have Received Treatment for HPV-associated H… (NCT05048459) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Comparing Two Surveillance Approaches for People Who Have Received Treatment for HPV-associated Head and Neck Cancer and Show No Signs of Disease
United States40 participantsStarted 2021-09-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.