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Microvascular Reconstruction For Advanced-Stage Head And Neck Cancer Patients
This study is currently recruiting participants.
Verified by Memorial Sloan-Kettering Cancer Center, April 2009
First Received: December 18, 2007   Last Updated: April 2, 2009   History of Changes
Sponsored by: Memorial Sloan-Kettering Cancer Center
Information provided by: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00578032
  Purpose

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
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

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • To describe overall pt-reported health-related QOL and cancerrelated symptoms pre-operatively and at 3, 6 and 12 mos following surgical resection and microvascular reconstruction for advanced oral cavity malignancies [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   None Retained

Biospecimen Description:

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
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.
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

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

Inclusion Criteria:

  • Patients undergoing surgical resection and microvascular reconstruction for stage III or IV mixed tumor malignancies of the oral cavity at Memorial Sloan-Kettering Cancer Center.
  • Patients at least 21 years of age

Exclusion Criteria:

  • Patients with primary tumor of the lips and/or skin
  • Patients who are less than 21 years old
  • Patients who do not speak the English language
  • Patients who are unable to comprehend the content of the questionnaires due to psychiatric disorders or cognitive impairment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00578032

Contacts
Contact: Andrea Pusaic, MD,MHS pusaica@mskcc.org
Contact: Snehal Patel, MD patels@mskcc.org

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Andrea Pusaic            
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Principal Investigator: Andrea Pusaic, MD, MHS Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

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

Keywords provided by Memorial Sloan-Kettering Cancer Center:
stage IV
head
neck
cancer

Study placed in the following topic categories:
Head and Neck Neoplasms
Quality of Life

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009