Reconstructive Surgery For Head And Neck Cancer Patients

Completed

• Conditions: Advanced Stage Head and Neck Cancer

• Registration Number: NCT00578032
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

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 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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2007-12-18
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-20
• Status Verified: 2017-10
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Last Update Submitted: 2017-10-17
• Last Update Posted: 2017-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	1 year

Secondary Outcome Measures

Name	Time	Method
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.	2 years

Trial Locations

Locations (1)

Memorial Sloan-Kettering Cancer Center; 🇺🇸 New York, New York, United States