Clinical trial NCT00578032: Reconstructive Surgery For Head And Neck Cancer Patients
Official title: Reconstructive Surgery For Head And Neck Cancer Patients: A Prospective Analysis Of Quality Of Life And Symptom Relief
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Advanced Stage Head and Neck Cancer
Keywords: head
neck
cancer
reconstruction
quality of life
07-150
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2007-12-20
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with head and and neck malignancies hat require simultaneous surgical resection and reconstruction of the ablative defect will be eligible to participate.

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.

Eligibility criteria: 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

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
timeFrame: 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.
timeFrame: 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Andrea Pusaic, MD, MHS
role: PRINCIPAL_INVESTIGATOR
References: