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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT01181648
First received: August 12, 2010
Last updated: October 6, 2014
Last verified: October 2014
  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:


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 2015
Estimated Primary Completion Date: August 2015 (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. A follow up letter will be sent to participants who do not return their completed study questionnaires.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: October 6, 2014
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, Squamous Cell
Oropharyngeal Neoplasms
Carcinoma
Head and Neck Neoplasms
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplasms, Squamous Cell
Otorhinolaryngologic Diseases
Otorhinolaryngologic Neoplasms
Pharyngeal Diseases
Pharyngeal Neoplasms
Stomatognathic Diseases

ClinicalTrials.gov processed this record on November 20, 2014