Measuring Patient Satisfaction With Facial Appearance: Development and Validation of a New Patient-Reported Outcome Measure
|ClinicalTrials.gov Identifier: NCT00530049|
Recruitment Status : Active, not recruiting
First Posted : September 17, 2007
Last Update Posted : September 6, 2017
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; and after dermatologic surgery for patients with cutaneous skin cancers.
|Condition or disease||Intervention/treatment|
|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|
- 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 preliminary questionnaires in the mail or clinic 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 questionnaires in clinic or by mail 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 by mail or in clinic.
|Study Type :||Observational|
|Estimated Enrollment :||1745 participants|
|Official Title:||Measuring Patient Satisfaction With Facial Appearance: Development and Validation of a New Patient-Reported Outcome Measure|
|Study Start Date :||August 2007|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||August 2018|
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 and after dermatologic surgery for patients with cutaneous skin cancers. . 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|
- Development of patient-reported outcome measure of quality of life related to facial appearance [ Time Frame: 2 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00530049
|United States, New York|
|New School for Social Research|
|New York, New York, United States, 10003|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|McMaster Children's Hospital at Hamilton Health Sciences|
|Hamilton, Ontario, Canada, L8N 3Z5|
|University College of London Hospitals|
|London, England, United Kingdom, WIT 3AA|
|Principal Investigator:||Andrea L. Pusic, MD, MHS||Memorial Sloan Kettering Cancer Center|
|Principal Investigator:||Peter G. Cordeiro, MD||Memorial Sloan Kettering Cancer Center|