FACE-Q in Facial Reconstructive Surgery: A Prospective Database
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ClinicalTrials.gov Identifier: NCT04842279 |
Recruitment Status :
Recruiting
First Posted : April 13, 2021
Last Update Posted : April 13, 2021
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Condition or disease | Intervention/treatment |
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Skin Cancer, Basal Cell Skin Cancer Skin Cancer, Non-Melanoma Skin Cancers - Squamous Cell Carcinoma Patient Satisfaction | Other: FACE-Q scale |
Patient perspective is essential as medicine progresses to become more patient centered. FACE-Q is a recently developed and validated patient-reported outcome measure (PROM) tool that allows clinicians to assess patient perspectives after skin cancer surgery of the face. The FACE-Q has more than 40 independent scales and checklist each measuring different patient reported outcomes (PRO).
The FACE-Q utilizes five scales to measure the psychometric, QoL, patient experience, and cosmetic outcomes. The FACE-Q was validated in both surgical and non-surgical patients. This is a single-center project to establish a prospective database of clinical information from patients who utilize FACE-Q in a clinical investigation. This database is being established in efforts to promote research in various patient populations Rationale The purpose of this prospective database would be to evaluate levels of satisfaction and QoL across various interventions and patient populations after using the FACE-Q PROM. Long term data collection will include information related to QoL, patient experience, and cosmetic outcomes. Many areas related to patient reported outcomes in the context of facial reconstruction surgery are in their early years. There are many areas of research needed to aid in clinical decision making. The database will allow these questions to be answered using a retrospective model and will provide the background information required to mount larger scale randomized controlled trials, when possible. Information collected in the database will also allow meaningful research to be conducted in a timely and cost-effective manner. For example database information could help answer, "Which patient characteristics are associated with higher FACE-Q scores in non-melanoma facial cancer patients?". The investigators will initiate a line of investigations that will characterize adults who use the FACE-Q in various clinical contexts with the ultimate goal of improving patient outcomes.
The study was designed in concordance with the Enhancing the Quality and Transparency of Health Research (EQUATOR) reporting guidelines using: The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE), and Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statements as well as based off previous prospective studies that used FACE-Q for PROMs.
Study Type : | Observational |
Estimated Enrollment : | 300 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | FACE-Q Measurement of the Patient Perspective in Facial Reconstructive Surgery: A Prospective Database |
Estimated Study Start Date : | April 20, 2021 |
Estimated Primary Completion Date : | July 20, 2021 |
Estimated Study Completion Date : | April 20, 2022 |

- Other: FACE-Q scale
FACE-Q is a recently developed and validated patient reported outcome measure (PROM) tool that allows clinicians to assess patient perspectives after skin cancer surgery of the face.The PROM is used to assess the perspective and impact of skin cancer as well as its treatment on the patient's quality of life (QoL). Patients with skin cancer may have increased anxiety, social isolation, and cosmetic concerns after surgery. The FACE-Q utilizes five scales to measure the psychometric, QoL, patient experience, and cosmetic outcomes. Raw scores are transformed to a 0-100 scale with a higher score indicating a better outcome.
Any studies using FACE-Q for facial surgery reconstruction at our center may be eligible for inclusion in the database
- FACE-Q score [ Time Frame: 12 months ]FACE-Q is a recently developed and validated patient reported outcome measure (PROM) tool that allows clinicians to assess patient perspectives after skin cancer surgery of the face.The PROM is used to assess the perspective and impact of skin cancer as well as its treatment on the patient's quality of life (QoL). Patients with skin cancer may have increased anxiety, social isolation, and cosmetic concerns after surgery. The FACE-Q utilizes five scales to measure the psychometric, QoL, patient experience, and cosmetic outcomes. Raw scores are transformed to a 0-100 scale with a higher score indicating a better outcome
- Facial photos [ Time Frame: 12 months ]Patient photos may be taken post-op from the other studies and will be included if performed

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Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
i. Age 18 years or older ii. Use of any module of the FACE-Q scale to measure a patient-reported outcome iii. Ability to provide informed consent
Exclusion Criteria:
i. Those patients who do not meet all of the above inclusion criteria will be excluded from the study

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04842279
Contact: Mark McRae, MD | 905) 522-1155 ext 32145 | Mcraem2@mcmaster.ca |
Canada, Ontario | |
St. Joseph's Healthcare Hamilton | Recruiting |
Hamilton, Ontario, Canada, L8N 4A6 | |
Contact: Mark MccRa, MD (905) 522-1155 ext 32145 Mcraem2@mcmaster.ca | |
Principal Investigator: Mark McRae, MD | |
Sub-Investigator: Matthew McRae, MD | |
Sub-Investigator: Sophocles Voineskos, MD | |
Sub-Investigator: Minh Huynh, MD |
Principal Investigator: | Mark McRae, MD | McMaster University |
Responsible Party: | Mark McRae, Principal Investigator, McMaster University |
ClinicalTrials.gov Identifier: | NCT04842279 |
Other Study ID Numbers: |
9446 |
First Posted: | April 13, 2021 Key Record Dates |
Last Update Posted: | April 13, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Skin Neoplasms Carcinoma, Basal Cell Neoplasms, Basal Cell Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms by Site Skin Diseases |