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

Completed

• Conditions: Squamous Cell Carcinoma of the Oropharynx
• Interventions: Behavioral: questionnaire and semi-structured interviews

• Registration Number: NCT01181648
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-12
• Study First Submitted QC: 2010-08-12
• Study First Posted: 2010-08-13
• Status Verified: 2018-06
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Last Update Submitted: 2018-06-19
• Last Update Posted: 2018-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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

Read More

Exclusion Criteria

• Diagnosed with recurrent disease following completion of primary curative treatment

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
oropharynx cancer survivors	questionnaire and semi-structured interviews	This study has two components. First, we will conduct a cross-sectional survey of 200 oropharynx cancer survivors, diagnosed with HPV+ tumors, who are at least 12 months from their last treatment. 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.

Primary Outcome Measures

Name	Time	Method
To assess quality of life in survivors	2 years	of oropharynx cancer at least one year after completion of curative treatment in patients with HPV+ disease versus HPV- disease.

Secondary Outcome Measures

Name	Time	Method
Explore the psychosocial impact of a HPV diagnosis	2 years	on survivors of HPV+ oropharynx cancer

Trial Locations

Locations (6)

Memorial Sloan Kettering at Mercy Medical Center; 🇺🇸 Rockville Centre, New York, United States

Memoral Sloan Kettering Cancer Center at Phelps; 🇺🇸 Sleepy Hollow, New York, United States

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Cancer Center @ Suffolk; 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering West Harrison; 🇺🇸 Harrison, New York, United States

Memoral Sloan Kettering Cancer Center; 🇺🇸 Basking Ridge, New Jersey, United States