Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer
|ClinicalTrials.gov Identifier: NCT01089803|
Recruitment Status : Completed
First Posted : March 19, 2010
Last Update Posted : December 4, 2015
|Condition or disease|
|Squamous Cell Carcinoma Laryngeal Cancer|
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.
|Study Type :||Observational|
|Actual Enrollment :||279 participants|
|Official Title:||Observational Study of Swallowing Function After Treatment of Advanced Laryngeal Cancer|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
Patients Treated with Laryngectomy
Patients initially treated with laryngectomy and followed for 12 months after receiving this treatment.
Patients Treated with Chemoradiation
Patients treated initially with chemoradiation and followed for 12 months after receiving treatment.
- Swallowing Function Scores [ 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.
- General Quality of Life [ 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).
- Speech Assessment [ 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.
- Head and Neck 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01089803
|United States, Minnesota|
|Masonic Cancer Center, University of Minnesota|
|Minneapolis, Minnesota, United States, 55455|
|Principal Investigator:||Bevan Yueh, MD, MPH||Masonic Cancer Center, University of Minnesota|