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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00530049
• Other study ID #: 07-098
• Secondary ID: MSKCC-07098
• Status: Completed
• Start date: August 14, 2007
• Est. completion date: December 17, 2021

Study information

• Verified date: December 2021
• Source: Memorial Sloan Kettering Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1745
• Est. completion date: December 17, 2021
• Est. primary completion date: December 17, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• questionnaire administration

Procedure:
• assessment of therapy complications

• psychosocial assessment and care

• quality-of-life assessment

Locations

Country	Name	City	State
Canada	McMaster Children's Hospital at Hamilton Health Sciences	Hamilton	Ontario
United Kingdom	University College of London Hospitals	London	England
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	New School for Social Research	New York	New York

Sponsors (6)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	McMaster University, National Cancer Institute (NCI), The New School for Social Research, University College, London, Yeshiva University

Countries where clinical trial is conducted

United States,  Canada,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of patient-reported outcome measure of quality of life related to facial appearance		2 years

External Links

•   Memorial Sloan Kettering Cancer Center