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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 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: April 3, 2014
Last verified: April 2014

August 12, 2010
April 3, 2014
August 2010
August 2015   (final data collection date for primary outcome measure)
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.
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 and to identify differences between patients with HPV+ disease versus HPV- disease.
Complete list of historical versions of study NCT01181648 on ClinicalTrials.gov Archive Site
Explore the psychosocial impact of a HPV diagnosis [ Time Frame: 2 years ] [ Designated as safety issue: No ]
on survivors of HPV+ oropharynx cancer
Same as current
Not Provided
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Long-Term Impact of Human Papillomavirus (HPV) on Quality of Life
Surviving Oropharynx Cancer: Long-Term Impact of Human Papillomavirus (HPV) on Quality of Life

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.

Not Provided
Observational
Time Perspective: Prospective
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Non-Probability Sample

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.

Squamous Cell Carcinoma of the Oropharynx
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.
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.
Intervention: Behavioral: questionnaire and semi-structured interviews
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
August 2015
August 2015   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Shrujal Baxi, MD 646-888-4236
Contact: David Pfister, MD 646-888-4232
United States
 
NCT01181648
10-111
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Shrujal Baxi, MD Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP