Long-Term Impact of Human Papillomavirus (HPV) on Quality of Life

Squamous Cell Carcinoma of the Oropharynx Clinical Trial

Official title:

Surviving Oropharynx Cancer: Long-Term Impact of Human Papillomavirus (HPV) on Quality of Life

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01181648
• Other study ID #: 10-111
• Status: Completed
• Start date: August 2010
• Est. completion date: June 2018

Study information

• Verified date: June 2018
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Squamous Cell
• Oropharyngeal Neoplasms
• Squamous Cell Carcinoma of the Oropharynx

Intervention

Behavioral:
• questionnaire and semi-structured interviews
Survivors will be asked to complete a brief, self-administered, paper-based survey to assess quality of life, mental health and employment status following completion of therapy. Second, in a subset of 20 survivors of HPV+ oropharynx cancer, we will conduct in-depth, semi-structured, face-to-face interviews addressing the psychosocial impact of the HPV diagnosis. A follow up letter will be sent to participants who do not return their completed study questionnaires.

Locations

Country	Name	City	State
United States	Memoral Sloan Kettering Cancer Center	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Cancer Center @ Suffolk	Commack	New York
United States	Memorial Sloan Kettering West Harrison	Harrison	New York
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	Memorial Sloan Kettering at Mercy Medical Center	Rockville Centre	New York
United States	Memoral Sloan Kettering Cancer Center at Phelps	Sleepy Hollow	New York

Sponsors (1)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess quality of life in survivors	of oropharynx cancer at least one year after completion of curative treatment in patients with HPV+ disease versus HPV- disease.	2 years
Secondary	Explore the psychosocial impact of a HPV diagnosis	on survivors of HPV+ oropharynx cancer	2 years

External Links

•   Memorial Sloan Kettering Cancer Center