Measuring Patient Satisfaction With Facial Appearance: Development and Validation of a New Patient-Reported Outcome Measure
2 other identifiers
observational
1,745
3 countries
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2007
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 14, 2007
CompletedFirst Submitted
Initial submission to the registry
September 13, 2007
CompletedFirst Posted
Study publicly available on registry
September 17, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 17, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 17, 2021
CompletedDecember 21, 2021
December 1, 2021
14.4 years
September 13, 2007
December 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Development of patient-reported outcome measure of quality of life related to facial appearance
2 years
Study Arms (1)
questionnaires
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
Interventions
Eligibility Criteria
Potential research subjects will be identified by a member of the patient's treatment team, the protocol investigator, or research team at Memorial Sloan-Kettering Cancer Center (MSKCC), or specified plastic surgeon at outside institution.
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Memorial Sloan Kettering Cancer Centerlead
- National Cancer Institute (NCI)collaborator
- McMaster Universitycollaborator
- The New School for Social Researchcollaborator
- University College, Londoncollaborator
- Yeshiva Universitycollaborator
Study Sites (4)
New School for Social Research
New York, New York, 10003, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
McMaster Children's Hospital at Hamilton Health Sciences
Hamilton, Ontario, L8N 3Z5, Canada
University College of London Hospitals
London, England, WIT 3AA, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea L. Pusic, MD, MHS
Memorial Sloan Kettering Cancer Center
- PRINCIPAL INVESTIGATOR
Peter G. Cordeiro, MD
Memorial Sloan Kettering Cancer Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2007
First Posted
September 17, 2007
Study Start
August 14, 2007
Primary Completion
December 17, 2021
Study Completion
December 17, 2021
Last Updated
December 21, 2021
Record last verified: 2021-12