Measuring Patient Satisfaction With Facial Appearance: Development and Validation of a New Patient-Reported Outcome Measure

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Memorial Sloan-Kettering Cancer Center
Sponsor:
Collaborators:
McMaster University
The New School for Social Research
University College, London
Yeshiva University
Information provided by (Responsible Party):
Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier:
NCT00530049
First received: September 13, 2007
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Measuring Patient Satisfaction With Facial Appearance: Development and Validation of a New Patient-Reported Outcome Measure

Resource links provided by NLM:


Further study details as provided by Memorial Sloan-Kettering Cancer Center:

Primary Outcome Measures:
  • Development of patient-reported outcome measure of quality of life related to facial appearance [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 1745
Study Start Date: August 2007
Estimated Study Completion Date: August 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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. 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: assessment of therapy complications Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

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 mailed preliminary questionnaires 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 mailed final questionnaires 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 (via mail).
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

Criteria

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 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).

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00530049

Contacts
Contact: Andrea Pusic, MD, MHS 646-888-3551

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Andrea L. Pusic, MD, MHS    646-888-3551      
Contact: Peter Cordeiro, MD    212-639-2521      
Principal Investigator: Andrea Pusic, MD, M.H.S.         
New School for Social Research Recruiting
New York, New York, United States, 10003
Contact: Lisa Rubin, PhD    212-229-5700      
Canada, Ontario
McMaster Children's Hospital at Hamilton Health Sciences Recruiting
Hamilton, Ontario, Canada, L8N 3Z5
Contact: Anne Klassen, DPhil    905-521-2000 ext. 73464      
United Kingdom
University College of London Hospitals Recruiting
London, England, United Kingdom, WIT 3AA
Contact: Stefan Cano, PhD    44-20-7636-8333      
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
McMaster University
The New School for Social Research
University College, London
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
  More Information

Additional Information:
No publications provided

Responsible Party: Memorial Sloan-Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT00530049     History of Changes
Other Study ID Numbers: 07-098, MSKCC-07098
Study First Received: September 13, 2007
Last Updated: July 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Memorial Sloan-Kettering Cancer Center:
psychosocial effects of cancer and its treatment
hypopharyngeal cancer
laryngeal cancer
lip and oral cavity cancer
metastatic squamous neck cancer with occult primary
nasopharyngeal cancer
oropharyngeal cancer
paranasal sinus and nasal cavity cancer
salivary gland cancer
tongue cancer
07-098

Additional relevant MeSH terms:
Head and Neck Neoplasms
Facies
Neoplasms by Site
Neoplasms
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 22, 2014