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

Conditions

Intervention / Treatment

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

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 3Z5
        • McMaster Children's Hospital at Hamilton Health Sciences
  • United Kingdom
    • England
      • London, England, United Kingdom, WIT 3AA
        • University College of London Hospitals
  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center
      • New York, New York, United States, 10003
        • New School for Social Research

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
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
Other: questionnaire administration
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment
Procedure: assessment of therapy complications

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Development of patient-reported outcome measure of quality of life related to facial appearance
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Collaborators

National Cancer Institute (NCI)
University College, London
McMaster University
The New School for Social Research
Yeshiva University

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.

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