FACE-Q in Facial Reconstructive Surgery: A Prospective Database

NCT ID: NCT04842279

Last Updated: 2021-04-13

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-20
• Study Completion Date: 2022-04-20

Brief Summary

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.

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.

Conditions

Skin Cancer, Basal Cell Skin Cancer Skin Cancer, Non-Melanoma Skin Cancers - Squamous Cell Carcinoma Patient Satisfaction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Mark McRae

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark McRae, MD

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Mark McRae, MD

Role: CONTACT

Mcraem2@mcmaster.ca

905) 522-1155 ext. 32145

Facility Contacts

Mark MccRa, MD

Role: primary

Mcraem2@mcmaster.ca

(905) 522-1155 ext. 32145

References

Huynh MNQ, Olaiya O, Kim PJ, Gallo L, Dunn E, Farrokhyar F, McRae MC, Voineskos S, McRae MH. A comparison of skin grafts versus local flaps for facial skin cancer from the patient perspective: protocol for a feasibility study. Jpn J Clin Oncol. 2023 Jun 1;53(6):489-493. doi: 10.1093/jjco/hyad018.

Reference Type: DERIVED

PMID: 36946321 (View on PubMed)

Other Identifiers

9446

Identifier Type: -

Identifier Source: org_study_id