FACE-Q in Facial Reconstructive Surgery: A Prospective Database

FACE-Q Measurement of the Patient Perspective in Facial Reconstructive Surgery: A Prospective Database

The primary objective is to establish a prospective database of clinical information, FACE-Q scores, and patient photographs (as appropriate) to enhance the understanding and practice of facial plastic and reconstructive surgery.

Study Overview

• Status: Recruiting
• Conditions: Skin Cancer, Basal Cell Skin Cancer Skin Cancer, Non-Melanoma Skin Cancers - Squamous Cell Carcinoma Patient Satisfaction
• Intervention / Treatment: Other: FACE-Q scale

Detailed Description

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
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Mark McRae, MD; Phone Number: 32145 905) 522-1155; Email: Mcraem2@mcmaster.ca

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • Recruiting
      • St. Joseph's Healthcare Hamilton
      • Contact: Mark MccRa, MD; Phone Number: 32145 (905) 522-1155; Email: Mcraem2@mcmaster.ca
      • Principal Investigator: Mark McRae, MD
      • Sub-Investigator: Matthew McRae, MD
      • Sub-Investigator: Sophocles Voineskos, MD
      • Sub-Investigator: Minh Huynh, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This database will collect existing or prospective data that is part of standard clinical care from the electronic medical record of patients which are part of any FACE-Q studies.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FACE-Q score	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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facial photos	Patient photos may be taken post-op from the other studies and will be included if performed	12 months

Collaborators and Investigators

• Sponsor: McMaster University
• Investigators: Principal Investigator: Mark McRae, MD, McMaster University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 20, 2021
• Primary Completion (Anticipated): July 20, 2021
• Study Completion (Anticipated): April 20, 2022

Study Registration Dates

• First Submitted: April 8, 2021
• First Submitted That Met QC Criteria: April 8, 2021
• First Posted (Actual): April 13, 2021

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Carcinoma; Neoplasms, Glandular and Epithelial; Skin Neoplasms; Carcinoma, Basal Cell; Neoplasms, Basal Cell
• Other Study ID Numbers: 9446 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No