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


N/A
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer, Psychosocial Effects of Cancer and Its Treatment

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Trial Information

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


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).


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 month 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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Development of patient-reported outcome measure of quality of life related to facial appearance

Outcome Time Frame:

2 years

Safety Issue:

No

Principal Investigator

Andrea L. Pusic, MD, MHS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

07-098

NCT ID:

NCT00530049

Start Date:

August 2007

Completion Date:

August 2014

Related Keywords:

  • Head and Neck Cancer
  • Psychosocial Effects of Cancer and Its Treatment
  • 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
  • Head and Neck Neoplasms
  • Facies

Name

Location

Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
New School for Social ResearchNew York, New York  10003