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
1 other identifier
observational
210
1 country
6
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2010
Longer than P75 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
August 12, 2010
CompletedFirst Posted
Study publicly available on registry
August 13, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedJune 20, 2018
June 1, 2018
7.8 years
August 12, 2010
June 19, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Explore the psychosocial impact of a HPV diagnosis
2 years
Study Arms (1)
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.
Interventions
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 Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- Diagnosed with recurrent disease following completion of primary curative treatment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Memoral Sloan Kettering Cancer Center
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Cancer Center @ Suffolk
Commack, New York, 11725, United States
Memorial Sloan Kettering West Harrison
Harrison, New York, 10604, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, 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, 10591, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Shrujal Baxi, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2010
First Posted
August 13, 2010
Study Start
August 1, 2010
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
June 20, 2018
Record last verified: 2018-06