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

Purpose

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.

Condition	Intervention
Squamous Cell Carcinoma of the Oropharynx	Behavioral: questionnaire and semi-structured interviews

Study Type:	Observational
Study Design:	Time Perspective: Prospective
Official Title:	Surviving Oropharynx Cancer: Long-Term Impact of Human Papillomavirus (HPV) on Quality of Life

Resource links provided by NLM:

MedlinePlus related topics: Cancer

Drug Information available for: Human Papillomaviruses

U.S. FDA Resources

Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:

To assess quality of life in survivors [ Time Frame: 2 years ] [ Designated as safety issue: No ]
of oropharynx cancer at least one year after completion of curative treatment in patients with HPV+ disease versus HPV- disease.

Secondary Outcome Measures:

Explore the psychosocial impact of a HPV diagnosis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
on survivors of HPV+ oropharynx cancer

Estimated Enrollment:	200
Study Start Date:	August 2010
Estimated Study Completion Date:	August 2014
Estimated Primary Completion Date:	August 2014 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
oropharynx cancer survivors 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.	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.

Groups/Cohorts

Assigned Interventions

oropharynx cancer survivors

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.

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
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.

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01181648

Contacts

Contact: Shrujal Baxi, MD	646-888-4236
Contact: David Pfister, MD	646-888-4232

Locations

United States, New Jersey
Memoral Sloan Kettering Cancer Center	Recruiting
Basking Ridge, New Jersey, United States
Contact: Shrujal Baxi, MD 646-888-4236
United States, New York
Memorial Sloan-Kettering Cancer Center @ Suffolk	Recruiting
Commack, New York, United States, 11725
Contact: Shrujal Baxi, MD 646-888-4236
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10065
Contact: Shrujal Baxi, MD 646-888-4236
Contact: David Pfister, MD 646-888-4232
Principal Investigator: Shrujal Baxi, MD
Memorial Sloan-Kettering at Mercy Medical Center	Recruiting
Rockville Centre, New York, United States
Contact: Shrujal Baxi, MD 646-888-4236
Memoral Sloan Kettering Cancer Center at Phelps	Recruiting
Sleepy Hollow, New York, United States, 10591
Contact: Shrujal Baxi, MD 646-888-4236

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

Investigators

Principal Investigator:

Shrujal Baxi, MD

Memorial Sloan-Kettering Cancer Center

More Information

Additional Information:

Memorial Sloan-Kettering Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:	NCT01181648 History of Changes
Other Study ID Numbers:	10-111
Study First Received:	August 12, 2010
Last Updated:	April 11, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:

Survivor
Human Papillomavirus (HPV)
Quality of Life
Surviving Oropharynx Cancer
10-111

Additional relevant MeSH terms:

Carcinoma
Carcinoma, Squamous Cell
Oropharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell

Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 21, 2013