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Sponsored by: |
Memorial Sloan-Kettering Cancer Center |
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Information provided by: | Memorial Sloan-Kettering Cancer Center |
ClinicalTrials.gov Identifier: | NCT00578032 |
The goal of this study is to better understand the changes in symptoms and overall quality of life after head and neck surgery and reconstruction. "Quality of Life" means how you feel about your life as a result of your disease and its treatment. Learning about changes in patients' quality of life will help doctors and future patients make more informed treatment decisions.
Condition | Intervention |
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Advanced Stage Head and Neck Cancer |
Behavioral: Quality of Life Questionaires & Interview: EORTC QLQ C-30, EORTC QLQ H&N-35, Health Behaviors,
Subjective Significance Questionnaire, Qualitative Assessment |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Microvascular Reconstruction For Advanced-Stage Head And Neck Cancer Patients: A Prospective Analysis Of Quality Of Life And Symptom Relief |
Estimated Enrollment: | 130 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Patients with AJCC stage III or IV malignancies of the oral cavity that require simultaneous surgical resection and microvascular reconstruction of the ablative defect will be eligible to participate.
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Behavioral: Quality of Life Questionaires & Interview: EORTC QLQ C-30, EORTC QLQ H&N-35, Health Behaviors,
Subjective Significance Questionnaire, Qualitative Assessment
All patients will complete the predefined questionnaires at the following four time points along the course of their care: preoperative clinic visit, and 3 months (±1 month), 6 months (±1), , and 12 months (±1 ) post-operatively. Completion of the questionnaires should take approximately 30 minutes
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This prospective, longitudinal study will evaluate patient-reported quality of life and symptomatology immediately prior to and for up to one year following surgical resection and microvascular reconstruction of advanced oral cavity malignancies.Patients with AJCC stage III or IV malignancies of the oral cavity that require simultaneous surgical resection and microvascular reconstruction of the ablative defect will be eligible to participate.Quality of life and symptom relief will be evaluated by both domain and disease specific questionnaires at four time points: pre-operatively, and 3 months (±1 month), 6 months (±1), and 12 months (±1) post-operatively. These assessment points represent clinically significant events in patients' post-operative course following head and neck surgery. Studies have shown that quality of life decreases significantly at three months after surgery but then reapproaches baseline levels around one year (1). Pre-operative responses will serve as the baseline for comparison. A subset of 20 patients with the 10 highest and 10 lowest quality of life summary scores will be interviewed one year (+/- 3 months) following surgery. The estimated accrual time for this study is 2.2 years . The estimated time for completion of the study is 3 years.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Patients with AJCC stage III or IV malignancies of the oral cavity that require simultaneous surgical resection and microvascular reconstruction of the ablative defect will be eligible to participate.
Inclusion Criteria:
Exclusion Criteria:
Contact: Andrea Pusaic, MD,MHS | pusaica@mskcc.org | |
Contact: Snehal Patel, MD | patels@mskcc.org |
United States, New York | |
Memorial Sloan-Kettering Cancer Center | Recruiting |
New York, New York, United States, 10065 | |
Contact: Andrea Pusaic |
Principal Investigator: | Andrea Pusaic, MD, MHS | Memorial Sloan-Kettering Cancer Center |
Responsible Party: | Memorial Sloan-Kettering Cancer Center ( Andrea Pusic, MD, MHS ) |
Study ID Numbers: | 07-150 |
Study First Received: | December 18, 2007 |
Last Updated: | April 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00578032 History of Changes |
Health Authority: | United States: Institutional Review Board |
stage IV head neck cancer |
Head and Neck Neoplasms Quality of Life |
Neoplasms Neoplasms by Site Head and Neck Neoplasms |