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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
Sponsor:
Information provided by (Responsible Party):
Mark McRae, McMaster University

Study Description
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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.

Condition or disease Intervention/treatment
Skin Cancer, Basal Cell Skin Cancer Skin Cancer, Non-Melanoma Skin Cancers - Squamous Cell Carcinoma Patient Satisfaction 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 Design
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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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • 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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Facial photos [ Time Frame: 12 months ]
    Patient photos may be taken post-op from the other studies and will be included if performed


Eligibility Criteria
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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
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.
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

Exclusion Criteria:

i. Those patients who do not meet all of the above inclusion criteria will be excluded from the study

Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Mark McRae, MD 905) 522-1155 ext 32145 Mcraem2@mcmaster.ca

Locations
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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         
Sponsors and Collaborators
McMaster University
Investigators
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Principal Investigator: Mark McRae, MD McMaster University
More Information
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Skin Neoplasms
Carcinoma, Basal Cell
Neoplasms, Basal Cell
Carcinoma
Neoplasms, Glandular and Epithelial
 Neoplasms by Histologic Type
Neoplasms
Neoplasms by Site
Skin Diseases