Measuring Patient Satisfaction With Facial Appearance: Development and Validation of a New Patient-Reported Outcome Measure
December 20, 2021 updated by: Memorial Sloan Kettering Cancer Center
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.
Study Overview
Status
Completed
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 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
Enrollment (Anticipated)
1745
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- McMaster Children's Hospital at Hamilton Health Sciences
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England
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London, England, United Kingdom, WIT 3AA
- University College of London Hospitals
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New York
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New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
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New York, New York, United States, 10003
- New School for Social Research
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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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:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Development of patient-reported outcome measure of quality of life related to facial appearance
Time Frame: 2 years
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2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Andrea L. Pusic, MD, MHS, Memorial Sloan Kettering Cancer Center
- Principal Investigator: Peter G. Cordeiro, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 14, 2007
Primary Completion (Actual)
December 17, 2021
Study Completion (Actual)
December 17, 2021
Study Registration Dates
First Submitted
September 13, 2007
First Submitted That Met QC Criteria
September 13, 2007
First Posted (Estimate)
September 17, 2007
Study Record Updates
Last Update Posted (Actual)
December 21, 2021
Last Update Submitted That Met QC Criteria
December 20, 2021
Last Verified
December 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 07-098
- MSKCC-07098
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.