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RECONSTRUCTIVE SURGERY For Head And Neck Cancer Patients: A Prospective Analysis Of Quality Of Life And Symptom Relief


N/A
21 Years
N/A
Open (Enrolling)
Both
Advanced Stage Head and Neck Cancer

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Trial Information

RECONSTRUCTIVE SURGERY For Head And Neck Cancer Patients: A Prospective Analysis Of Quality Of Life And Symptom Relief


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

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

Outcome Time Frame:

1 year

Safety Issue:

Yes

Principal Investigator

Andrea Pusaic, MD, MHS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

07-150

NCT ID:

NCT00578032

Start Date:

December 2007

Completion Date:

December 2013

Related Keywords:

  • Advanced Stage Head and Neck Cancer
  • head
  • neck
  • cancer
  • reconstruction
  • quality of life
  • 07-150
  • Head and Neck Neoplasms

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021