Clinical trial NCT01181648: Long-Term Impact of Human Papillomavirus (HPV) on Quality of Life
Official title: Surviving Oropharynx Cancer: Long-Term Impact of Human Papillomavirus (HPV) on Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Squamous Cell Carcinoma of the Oropharynx
Keywords: Survivor
Human Papillomavirus (HPV)
Quality of Life
Surviving Oropharynx Cancer
10-111
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2010-08-13
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Potential research subjects will be identified through a Dataline query. While Dataline should capture most eligible patients, potential subjects can also be identified by a member of the Head and Neck DMT.

Brief summary: The investigators are doing this study to learn about the quality of life patients have at the end of treatment. Some patients' cancers are related to human papilloma virus or HPV; others are not. HPV is a virus that can be sexually transmitted and is known to cause some types of cancers. If your throat cancer was related to HPV, your doctor can discuss this with you in detail. The investigators want to see if there are differences in quality of life between patients whose cancers are caused by HPV and those who cancers are not caused by HPV. Throat cancers caused by HPV behave differently than throat cancers not caused by HPV. The investigators believe that patients with these two different types of throat cancer will also have different experiences after completing therapy. The investigators would like to understand what those differences are. The long-term goal of this study is to see what symptoms most patients have. The investigators can then try to treat them earlier, and hopefully, improve the symptoms. The investigators will also be able to plan more research to improve treatment for symptoms following treatment for cancer of the mouth and throat.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Diagnosis of squamous cell carcinoma of the oropharynx confirmed by the pathology department at MSKCC
* Completed last treatment for oropharynx cancer (surgery, chemotherapy, or radiation) at least 12 months and no more than 5 years before the date of study enrollment
* Known tumor status or tumor available for HPV testing \[based on chromogenic in situ hybridization with wide spectrum HPV probe (HPV III family 16 probe (Ventana) with affinity to HPV genotypes 16, 18, 31, 33, 35, 45, 51, 52, 56, 58, and 66) or p16 immunohistochemistry done in a Clinical Laboratory Improvement Amendment (CLIA)-approved laboratory; if either of these 2 tests are positive, the patient is classified as positive\].
* Able to speak and read English (study questionnaire-Aim 1 and interview guide-Aim 2 are currently only available in English).
* Received at least one component of treatment for oropharynx cancer at MSKCC or the regional network sites
* If radiation therapy was part of treatment, it must have been delivered at MSKCC or the regional network sites
* For Aim 2 only, diagnosed with an HPV+ oropharynx cancer and have knowledge of this diagnosis prior to study enrollment

Exclusion Criteria:

* Diagnosed with recurrent disease following completion of primary curative treatment

Primary outcomes:
measure: To assess quality of life in survivors
timeFrame: 2 years
Secondary outcomes:
measure: Explore the psychosocial impact of a HPV diagnosis
timeFrame: 2 years
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Memoral Sloan Kettering Cancer Center
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Cancer Center @ Suffolk
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering West Harrison
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Rockville Centre
country: United States
facility: Memorial Sloan Kettering at Mercy Medical Center
state: New York
city: Sleepy Hollow
country: United States
facility: Memoral Sloan Kettering Cancer Center at Phelps
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Shrujal Baxi, MD
role: PRINCIPAL_INVESTIGATOR
References: