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

Primary Purpose

Squamous Cell Carcinoma

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Standard surveillance

Telemedicine surveillance (tele-surveillance)

Questionnaires

About this trial

This is an interventional supportive care trial for Squamous Cell Carcinoma focused on measuring Tele-Surveillance, Remote Symptom Monitoring, 21-347, HPV-associated Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Memorial Sloan Kettering Cancer Center (All Protocol Activities)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard surveillance

Telemedicine surveillance (tele-surveillance)

Arm 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

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.

Outcomes

Primary Outcome Measures

Progression-Free Survival (PFS)

PFS will be defined as pathologic evidence of local or distant tumor progression or death from any cause. Patients

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05048459

First Posted

September 1, 2021

Last Updated

January 4, 2023

Sponsor

Memorial Sloan Kettering Cancer Center

1. Study Identification

Unique Protocol Identification Number

NCT05048459

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2021 (Actual)

Primary Completion Date

September 2023 (Anticipated)

Study Completion Date

September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Memorial Sloan Kettering Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Squamous Cell Carcinoma

Keywords

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

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard surveillance

Arm Type

Active Comparator

Arm 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

Arm Title

Telemedicine surveillance (tele-surveillance)

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Standard surveillance

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Telemedicine surveillance (tele-surveillance)

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Questionnaires

Intervention Description

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

Primary Outcome Measure Information:

Title

Progression-Free Survival (PFS)

Description

PFS will be defined as pathologic evidence of local or distant tumor progression or death from any cause. Patients

Time Frame

2 years

Secondary Outcome Measure Information:

Title

Locoregional recurrence (LRR)

Description

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Kaveh Zakeri, MD

Phone

848-225-6435

zakerik@mskcc.org

First Name & Middle Initial & Last Name or Official Title & Degree

Nancy Lee, MD

Phone

212-639-3341

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kaveh Zakeri, MD

Organizational Affiliation

Memorial Sloan Kettering Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Kaveh Zakeri, MD

Phone

848-225-6435

First Name & Middle Initial & Last Name & Degree

Nancy Lee, MD

Phone

212-639-3341

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Links:

URL

http://www.mskcc.org/mskcc/html/44.cfm

Description

Memorial Sloan Kettering Cancer Center

Learn more about this trial

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

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