Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455, United States
NCT Number: NCT01089803
The purpose of this prospective, multi-institutional, observational cohort study is to determine if an initial surgical approach leads to better function and quality of life than primary chemoradiation in a subset of patients with advanced hypopharyngeal and laryngeal cancers.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Minneapolis, Minnesota, 55455, United States
At the time of registration patients will be categorized into 2 groups based on the initial treatment plan as either chemoradiation-based or surgically-based (laryngectomy). Treatment will be assigned by the patient's physician, it will not be assigned by the study.
Patients will be asked to complete a series of 4 questionnaires addressing swallowing function, generic health status, head and neck cancer-specific quality of life, and self-reported speech function at 3 time points (baseline, 6 months and 12 months after the end of treatment). The treating physician will provide basic clinical information at these same time points. In centers where swallowing and voice assessments are done as part of standard of care, data from these studies will also be provided.
Study entry is open to all adults regardless of gender or ethnic background. Specific information regarding the definitive treatment (surgery or chemoradiation) will be provided to the patient by the treating physician as part of the routine standard of care. Any treatment related side effects, as well as the duration of therapy and follow-up will be managed by the treating physician. Participation in this study will have no effect on the initial treatment decisions or the course of care.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 12 months after Treatment
The primary outcome will be self-reported swallowing function (M.D. Anderson Dysphagia Inventory questionnaire - MDADI) 12 months after treatment. Analysis will compare MDADI scores of patients treated initially with laryngectomy vs. those of patients treated initially with chemoradiation.
Time frame: PreTreatment, 6 Months and 12 Months After Treatment
The SF-12 Quality of Life questionnaire will be used to assess general health status. The SF-12 contains one or two items that measure each of eight domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these eight health domains, and two summary measures of physical and mental health: the Physical Component Summary (PCS) and Mental Component Summary (MCS).
Time frame: PreTreatment, 6 Months and 12 Months After Treatment
Speech analysis will focus primarily on speech intelligibilty and acceptability to both clinicians and naive listeners, and less on voice quality per se using the Voice Handicap Index. The Voice Handicap Index (VHI) measures the influence of voice problems on a patient's quality of life.
Time frame: PreTreatment, 6 Months and 12 Month After Treatment
The University of Washington Quality of Life Assessment Questionnaire will be administered. This questionnaire is specifically designed to capture head and neck cancer-specific function.
University of Minnesota
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT02586207
Carcinoma, Carcinoma, Squamous Cell
La Jolla, California, United States
View Trial DetailsNCT07209189
Carcinoma, Carcinoma, Squamous Cell
Baltimore, Maryland, United States
View Trial DetailsNCT00101582
Carcinoma, Carcinoma, Squamous Cell
View Trial DetailsNCT01208883
Carcinoma, Carcinoma, Squamous Cell
Ghent, Belgium
View Trial Details