Standard vs. Telemedicine Surveillance for Head and Neck Cancer

Overseen By Nancy Lee, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Disqualifiers: Other trials, Recurrent disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine which follow-up method is better for individuals with HPV-related head and neck cancer who show no signs of the disease after treatment. It compares traditional in-person check-ups, known as standard surveillance, with telemedicine, where patients connect with their healthcare team through video calls or phone from home. The study examines how each approach affects quality of life, health outcomes, costs, and satisfaction levels among doctors and patients. Individuals who recently completed treatment for HPV-associated cancer and show no evidence of disease may be suitable candidates for this trial. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance future care options.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that telemedicine surveillance is safe for head and neck cancer patients?

Research shows that telemedicine is generally safe for patients with head and neck cancer. Studies have found that patients using telemedicine feel more in control of their health and can reduce clinic visits. This approach allows patients to stay at home while maintaining regular check-ins with their doctors through video or phone calls.

Although specific safety data from clinical trials for telemedicine in this context is lacking, its use for medical follow-ups has become more common and accepted, especially during the COVID-19 pandemic. This study does not test a new drug or treatment but rather a different way to monitor health after treatment. No major safety issues have been reported with telemedicine for follow-ups. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial comparing telemedicine surveillance to standard care for head and neck cancer because it could revolutionize how patients are monitored after treatment. Unlike traditional follow-up, which requires in-person visits and procedures at a clinic, telemedicine allows patients to stay at home and still receive comprehensive care through video conferencing and phone calls. This approach could make cancer surveillance more convenient and accessible, especially for those who live far from healthcare facilities or have mobility issues. By potentially reducing the need for frequent clinic visits, telemedicine might also help lower healthcare costs and improve patients' quality of life.

What evidence suggests that this trial's surveillance methods could be effective for HPV-associated head and neck cancer?

This trial will compare standard surveillance with telemedicine surveillance (tele-surveillance) for head and neck cancer. Research has shown that telemedicine benefits patients with head and neck cancer. Studies indicate that tele-surveillance increases patients' sense of control and reduces hospital visits. It also enhances health management through remote check-ups and online communication. Both patients and doctors express high satisfaction with telemedicine, which has been linked to fewer hospital trips. This suggests that tele-surveillance could effectively manage head and neck cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Nancy Lee, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 who've had HPV-related squamous cell carcinoma in the oropharynx, are now disease-free after treatment, and can give informed consent. They should be able to speak and read English fluently. Those treated more than 9 months ago or with incomplete response/recurrent disease aren't eligible.

Inclusion Criteria

I may have had a CT or MRI scan after treatment.

My scans show no cancer signs after radiation, confirmed by my cancer doctors.

I can care for myself but may not be able to do heavy physical work.

Exclusion Criteria

My cancer did not fully respond or came back after treatment, as shown on a PET/CT scan.

I finished my radiation and chemotherapy over 9 months ago.

I am in a head and neck cancer trial with specific follow-up requirements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surveillance

Participants undergo either standard in-person surveillance or tele-surveillance to monitor for disease progression

2 years

Regular visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after surveillance

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Questionnaires
• Standard surveillance
• Telemedicine surveillance (tele-surveillance)

Trial Overview

The study compares two ways of monitoring patients after treating HPV-associated head and neck cancer: standard in-person check-ups versus telemedicine (remote) check-ups. It will assess quality of life, health outcomes, costs involved, and satisfaction levels with remote surveillance.

How Is the Trial Designed?

Group I: Telemedicine surveillance (tele-surveillance) Experimental Treatment 2 Interventions

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.

Group II: Standard surveillance Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+

Published Research Related to This Trial

The follow-up process for head and neck cancer (HNC) patients is currently inconsistent, with various guidelines leading to potentially unnecessary discomfort and costs, highlighting the need for standardized protocols.

This review synthesizes literature from 1980 to 2009 to provide evidence-based recommendations for effective post-treatment surveillance, including optimal follow-up intervals and imaging modalities, aimed at improving patient care and resource management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Making sense of post-treatment surveillance in head and neck cancer: when and what of follow-up. Manikantan, K., Khode, S., Dwivedi, RC., et al.[2015]

In a study of 302 patients with advanced head and neck squamous cell carcinoma, the overall 5-year survival rate was 56%, indicating a significant challenge in long-term survival after treatment.

Routine follow-up for these patients primarily serves to evaluate treatment outcomes and provide emotional support, rather than significantly improving survival rates after recurrence or the development of new tumors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is routine follow-up useful after combined-modality therapy for advanced head and neck cancer? Cooney, TR., Poulsen, MG.[2021]

A retrospective analysis of head and neck cancer patients revealed that 98% found telephone consultations beneficial, with 30% preferring them over in-person visits, especially those who traveled long distances or had lower stage disease.

The study suggests that telephone consultations can effectively complement traditional face-to-face appointments, allowing for reduced hospital visits while ensuring continued patient follow-up, with 68% of patients expressing interest in maintaining this practice post-pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of telephone consultations for head and neck cancer follow up: a patient satisfaction survey. Stewart, R., Collins, L., Kerr, B., et al.[2021]

In a study of 221 head and neck cancer patients, only 50.2% adhered to surveillance guidelines, with distance from the treatment center being a key factor affecting adherence.

Long-term adherence to surveillance after treatment completion was found to significantly improve survival rates, indicating its importance for better prognosis in head and neck cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence with National Comprehensive Cancer Network posttreatment surveillance guidelines in patients with head and neck cancer. Tam, S., Nurgalieva, Z., Weber, RS., et al.[2020]

In a study of 1078 head and neck cancer patients monitored through symptom-based telephone assessments, new symptoms reported during consultations were linked to a 6.0% rate of locoregional cancer recurrence within the first year after treatment, indicating the importance of monitoring for new symptoms.

While the telephone assessment showed high specificity (89.4%) for identifying cancer recurrence, its low sensitivity (35.3%) suggests that relying solely on patient-reported symptoms may not be sufficient for effective surveillance, especially since most patients did not have face-to-face evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Symptom-based remote assessment in post-treatment head and neck cancer surveillance: A prospective national study. Zhang, H., Hardman, JC., Tikka, T., et al.[2022]

In a study of 64 head and neck cancer patients at a public hospital in San Francisco, the median time from diagnosis to treatment initiation was 57 days, which is longer than reported in other public hospital settings, indicating potential delays in care.

Adherence to posttreatment surveillance was low, with only 69% of patients attending follow-up visits in the first year, dropping to 47% by the fifth year, highlighting challenges in maintaining ongoing care for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gaps in Treatment and Surveillance: Head and Neck Cancer Care in a Safety-Net Hospital. Yu, K., Westbrook, M., Brodie, S., et al.[2022]

Recurrence of head and neck squamous cell carcinoma is most likely to occur within the first three years after treatment, suggesting that intensive follow-up may not be necessary beyond this period for many patients.

Patients with laryngeal carcinoma may need continued surveillance due to the risk of delayed recurrence, highlighting the importance of tailored follow-up strategies and patient education in managing head and neck cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can head and neck cancer patients be discharged after three years? Kumar, R., Putnam, G., Dyson, P., et al.[2019]

In a study of 452 patients with head and neck squamous cell carcinoma, only 23.5% adhered to the NCCN follow-up guidelines in the first year, but this adherence was linked to improved 5-year overall and disease-specific survival rates.

While first-year adherence to follow-up guidelines was beneficial for survival, consistent adherence over 5 years did not show a significant impact on survival outcomes, indicating that early follow-up may be more critical than long-term adherence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Value of Adherence to Posttreatment Follow-Up Guidelines for Head and Neck Squamous Cell Carcinoma. Stone, A., Liu, J., Lin, J., et al.[2023]

A qualitative study involving 21 physicians revealed that there is significant variation in how surveillance guidelines for head and neck cancer (HNC) are interpreted, indicating a need for clearer protocols.

Clinicians expressed openness to deintensifying surveillance practices but highlighted concerns about potential increases in patient anxiety and the importance of maintaining strong patient-physician relationships and monitoring for treatment-related side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinician Attitudes and Beliefs About Deintensifying Head and Neck Cancer Surveillance. Chen, MM., Mott, NM., Miller, J., et al.[2022]

The median overall survival for patients with recurrent/metastatic head and neck squamous cell carcinoma improved from 6.7 months (1998-2007) to 11.8 months (2008-2019), indicating advancements in treatment efficacy over time.

Patterns of recurrence show that over half of recurrences happen within 6 months of treatment, and HPV-positive patients are more likely to develop distant metastases, suggesting the need for personalized surveillance strategies based on HPV status and other risk factors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of recurrence in head and neck squamous cell carcinoma to inform personalized surveillance protocols. Haring, CT., Kana, LA., Dermody, SM., et al.[2023]

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