RECONSTRUCTIVE SURGERY For Head And Neck Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00578032
First received: December 18, 2007
Last updated: August 5, 2014
Last verified: August 2014

December 18, 2007
August 5, 2014
December 2007
December 2015   (final data collection date for primary outcome measure)
To describe overall pt-reported health-related QOL and cancer related symptoms pre-operatively and at 3, 6 and 9 mos following surgical resection and reconstruction for head & neck malignancies [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
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 ]
Complete list of historical versions of study NCT00578032 on ClinicalTrials.gov Archive Site
To describe changes in patient-reported health-related quality of life and cancer-related symptoms within 9 or 12 months following surgical resection and reconstruction. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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RECONSTRUCTIVE SURGERY For Head And Neck Cancer Patients
RECONSTRUCTIVE SURGERY For Head And Neck Cancer Patients: A Prospective Analysis Of Quality Of Life And Symptom Relief

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.

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 reconstruction head and neck malignancies.Patients with head and neck malignancies that require simultaneous surgical resection and 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 9 months (-1 and +3) 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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample

Patients with head and and neck malignancies hat require simultaneous surgical resection and reconstruction of the ablative defect will be eligible to participate.

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
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 9 months (1 and +3) post-operatively. Completion of the questionnaires should take approximately 30 minutes
1
Patients with head and neck malignancies that require simultaneous surgical resection and reconstruction of the ablative defect will be eligible to participate.
Intervention: Behavioral: Quality of Life Questionaires & Interview: EORTC QLQ C-30, EORTC QLQ H&N-35, Health Behaviors, Subjective Significance Questionnaire, Qualitative Assessment
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
130
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients undergoing surgical resection and reconstruction for every stage head and neck malignancies at Memorial Sloan-Kettering Cancer Center.
  • Patients at least 21 years of age

Exclusion Criteria:

  • 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
  • Patients who cannot complete the pre-operative questionnaires during consent
Both
21 Years and older
No
Contact: Andrea Pusaic, MD,MHS 212-639-5085
Contact: Snehal Patel, MD 212-639-3412
United States
 
NCT00578032
07-150
Not Provided
Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
Not Provided
Principal Investigator: Andrea Pusaic, MD, MHS Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP