Developing a Questionnaire for Assessing Quality of Life Related to Facial Appearance in Patients Who Have Undergone or Are Planning to Undergo Surgery and Reconstruction for Head and Neck Cancer - Full Text View

Sponsors and Collaborators:	Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00530049

Purpose

RATIONALE: Developing a questionnaire that patients can use to assess their quality of life related to the appearance of their face after surgery may help doctors plan the best treatment for patients undergoing surgery and reconstruction for head and neck cancer in the future.

PURPOSE: This clinical trial is developing a questionnaire for assessing quality of life related to facial appearance in patients who have undergone or are planning to undergo surgery and reconstruction for head and neck cancer.

Condition	Intervention
Cancer-Related Problem/Condition Head and Neck Cancer	Procedure: assessment of therapy complications Procedure: psychosocial assessment and care Procedure: quality-of-life assessment Procedure: questionnaire administration

MedlinePlus related topics: Cancer Head and Neck Cancer

U.S. FDA Resources

Study Type:	Observational
Official Title:	Development and Validation of a New Patient-Reported Outcome Instrument on the Impact of Altered Facial Appearance Following Oncologic Head and Neck Resection and Reconstruction

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Development of patient-reported outcome measure of quality of life related to facial appearance

Estimated Enrollment:	855
Study Start Date:	August 2007
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

To develop and validate a new patient-reported outcome measure of quality of life related to facial appearance following oncologic head and neck resection and reconstruction.

OUTLINE:

Part 1 (questionnaire content generation and development of preliminary instrument [post-operative patients only]): Patients undergo semi-structured interview with a trained interviewer and answer open-ended questions. Statements concerning facial appearance post-resection and reconstruction are extracted to generate items for the preliminary instrument. The preliminary instrument is developed from review of the literature, qualitative interviews with patients, and expert opinion (head and neck surgeons, reconstructive surgeons, and other relevant health care providers, including nurse clinicians). The instrument is then pre-tested on a small sample of patients via mail to clarify ambiguities in the wording of items, confirm appropriateness, and determine acceptability and completion time.
Part 2 (field-testing with item reduction and development of final rating scale): Post-operative patients complete 2 copies of the mailed preliminary questionnaires approximately 2 weeks apart. Pre-operative patients complete the questionnaire prior to surgery (during preoperative appointment) and again at least 3 months after surgery (via mail). Data are analyzed to determine the most valid grouping of items into measurement scales for development of the final instrument.
Part 3 (psychometric evaluation of the patient-reported outcome questionnaire): Post-operative patients complete 2 copies of the mailed final questionnaires approximately 2 weeks apart. They also complete several other well-established, validated instruments used to measure patient-reported quality of life and symptomatology in order to aid in the evaluation of convergent and discriminant validity. Pre-operative patients complete the final questionnaire prior to surgery (during preoperative appointment) and again at least 3 months after surgery (via mail).

PROJECTED ACCRUAL: 675 post-operative patients and 180 pre-operative patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Meets one of the following criteria:
- Head and neck cancer patient who has altered facial appearance secondary to oncologic head and neck surgical resection and reconstruction (post-operative cohort)
  - Reconstruction is defined as skin grafts, local or free tissue transfer
  - Has completed surgery at MSKCC between 6 months to 7 years ago
  - No direct closure of surgical defect performed (i.e., no reconstruction surgery)
- Head and neck cancer patient who is scheduled to undergo oncologic head and neck surgical resection and reconstruction with anticipated altered facial appearance (pre-operative cohort)

PATIENT CHARACTERISTICS:

No blindness
No active psychiatric illness or cognitive or sensory impairment that, in the opinion of the investigator, is severe enough to preclude participation in the study
No physical impairment that may prevent the patient from filling out the paper and pencil survey

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No participation in more than 1 part of the study

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530049

Locations

United States, New York
Memorial Sloan-Kettering Cancer Center	Recruiting
New York, New York, United States, 10021
Contact: Andrea L. Pusic, MD, MHS 212-639-5085 pusica@mskcc.org
New School for Social Research	Recruiting
New York, New York, United States, 10003
Contact: Lisa Rubin, PhD 212-229-5700
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences	Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Anne Klassen, DPhil 905-521-2000 ext. 73464
United Kingdom, England
University College of London Hospitals	Recruiting
London, England, United Kingdom, WIT 3AA
Contact: Stefan Cano, PhD 44-20-7636-8333

Sponsors and Collaborators

Memorial Sloan-Kettering Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Andrea L. Pusic, MD, MHS	Memorial Sloan-Kettering Cancer Center
Principal Investigator:	Peter G. Cordeiro, MD	Memorial Sloan-Kettering Cancer Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000564263, MSKCC-07098
Study First Received:	September 13, 2007
Last Updated:	December 16, 2008
ClinicalTrials.gov Identifier:	NCT00530049
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

psychosocial effects/treatment
hypopharyngeal cancer
laryngeal cancer
lip and oral cavity cancer
metastatic squamous neck cancer with occult primary

nasopharyngeal cancer
oropharyngeal cancer
paranasal sinus and nasal cavity cancer
salivary gland cancer

Study placed in the following topic categories:

Nasopharyngeal carcinoma
Facies
Metastatic squamous neck cancer with occult primary
Oral cancer
Head and Neck Neoplasms
Laryngeal carcinoma

Quality of Life
Hypopharyngeal cancer
Laryngeal Neoplasms
Lip and oral cavity cancer
Salivary Gland Diseases

Additional relevant MeSH terms:

Disease Attributes
Neoplasms
Pathologic Processes
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009