Overview

This trial is active, not recruiting.

Conditions head and neck cancer, psychosocial effects of cancer and its treatment
Treatments questionnaire administration, assessment of therapy complications, psychosocial assessment and care, quality-of-life assessment
Sponsor Memorial Sloan Kettering Cancer Center
Collaborator National Cancer Institute (NCI)
Start date August 2007
End date August 2016
Trial size 1745 participants
Trial identifier NCT00530049, 07-098, MSKCC-07098

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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: Questionnaire content generation and development of preliminary instrument Field-testing the preliminary questionnaire with item reduction and development of final questionnaire Psychometric evaluation of final questionnaire
questionnaire administration
assessment of therapy complications
psychosocial assessment and care
quality-of-life assessment

Primary Outcomes

Measure
Development of patient-reported outcome measure of quality of life related to facial appearance
time frame: 2 years

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Age 18 to 99 years. - Patients who have altered facial appearance secondary to an oncologic head and neck surgical resection and reconstruction. Reconstruction will be defined as complex linear closures, skin grafts, local flaps or free tissue transfer (oncologic Post-op cohort). - Patients who have undergone cosmetic plastic surgery procedures to the head and neck unrelated to a diagnosis of cancer (non-oncologic Post-op cohort). - Patients with cutaneous skin cancers of the head and neck region treated in the dermatologic surgery setting (dermatology Post-op cohort) - Patients who have completed surgery at MSKCC between 1 week to 7 years ago (Post-op cohorts). - Patients who have completed facial surgery 6 weeks (+/- 1 week) ago (early postoperative subset-Phase I). - Patients who are scheduled to undergo oncologic head and neck resection and reconstruction with anticipated altered facial appearance (Pre-op). - Patients who are scheduled to undergo dermatologic surgery due to diagnosis cutaneous skin cancers of the head and neck region (dermatology Pre-op cohort) Exclusion Criteria: - Active psychiatric illness, cognitive or sensory impairment that in the opinion of the investigator is severe enough to preclude participation in the study. - Moderate to severe cognitive impairment. - Blindness. - Physical impairment that may prevent the respondent from filling out the paper and pencil survey.

Additional Information

Official title Measuring Patient Satisfaction With Facial Appearance: Development and Validation of a New Patient-Reported Outcome Measure
Principal investigator Andrea L. Pusic, MD, MHS
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 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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center.