Clinical trial · Observational
Measuring Patient Satisfaction With Facial Appearance: Development and Validation of a New Patient-Reported Outcome Measure
NCT00530049CI-TRIAL-00055608completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Psychosocial Effects of Cancer and Its Treatment | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| assessment of therapy complications | Procedure | — | UNRESOLVED |
| psychosocial assessment and care | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- questionnaires
- description
- 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
- interventionNames
- Other: questionnaire administration
- Procedure: assessment of therapy complications
- Procedure: psychosocial assessment and care
- Procedure: quality-of-life assessment
Primary outcomes (1)
- measure
- Development of patient-reported outcome measure of quality of life related to facial appearance
- timeFrame
- 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.