Overview

This trial is active, not recruiting.

Condition advanced stage head and neck cancer
Treatment quality of life questionaires & interview: eortc qlq c-30, eortc qlq h&n-35, health behaviors, subjective significance questionnaire, qualitative assessment
Sponsor Memorial Sloan Kettering Cancer Center
Start date December 2007
End date December 2016
Trial size 130 participants
Trial identifier NCT00578032, 07-150, NCT00573625

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
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 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

Primary Outcomes

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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 21 years old.

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

Additional Information

Official title Reconstructive Surgery For Head And Neck Cancer Patients: A Prospective Analysis Of Quality Of Life And Symptom Relief
Principal investigator Andrea Pusaic, MD, MHS
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.