Measuring Patient Satisfaction With Facial Appearance: Development and Validation of a New Patient-Reported Outcome Measure
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.
Head and Neck Cancer
Psychosocial Effects of Cancer and Its Treatment
Other: questionnaire administration
Procedure: assessment of therapy complications
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Measuring Patient Satisfaction With Facial Appearance: Development and Validation of a New Patient-Reported Outcome Measure|
- Development of patient-reported outcome measure of quality of life related to facial appearance [ Time Frame: 2 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2007|
|Estimated Study Completion Date:||August 2014|
|Estimated Primary Completion Date:||August 2014 (Final data collection date for primary outcome measure)|
The purpose of this study is to develop a PRO instrument that measures quality of life as relates to facial appearance after head and neck cancer reconstruction surgery. To develop this measure, we will adhere to the following sequential steps recommended by quality of life experts. Thus, the study will have three parts:
|Other: questionnaire administration Procedure: assessment of therapy complications Procedure: psychosocial assessment and care Procedure: quality-of-life assessment|
- 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.
- 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 1 month 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 1 month after surgery (via mail).
|United States, New York|
|Memorial Sloan-Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Andrea L. Pusic, MD, MHS 646-888-3551|
|Contact: Peter Cordeiro, MD 212-639-2521|
|Principal Investigator: Andrea Pusic, MD, M.H.S.|
|New School for Social Research||Recruiting|
|New York, New York, United States, 10003|
|Contact: Lisa Rubin, PhD 212-229-5700|
|McMaster Children's Hospital at Hamilton Health Sciences||Recruiting|
|Hamilton, Ontario, Canada, L8N 3Z5|
|Contact: Anne Klassen, DPhil 905-521-2000 ext. 73464|
|University College of London Hospitals||Recruiting|
|London, England, United Kingdom, WIT 3AA|
|Contact: Stefan Cano, PhD 44-20-7636-8333|
|Principal Investigator:||Andrea L. Pusic, MD, MHS||Memorial Sloan-Kettering Cancer Center|
|Principal Investigator:||Peter G. Cordeiro, MD||Memorial Sloan-Kettering Cancer Center|