## Protocol Section
### Identification Module
**NCT ID:** NCT04842279

**Brief Title:** FACE-Q in Facial Reconstructive Surgery: A Prospective Database

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

#### Organization Study ID Info
**ID:** 9446
#### Organization
**Class:** OTHER
**Full Name:** McMaster University
### Status Module
#### Completion Date
**Date:** 2022-04-20

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2021-04-13

**Type:** ACTUAL

**Last Update Submit Date:** 2021-04-08

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-07-20

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-04-20

**Type:** ESTIMATED

**Status Verified Date:** 2021-04

#### Study First Post Date
**Date:** 2021-04-13
**Type:** ACTUAL
**Study First Submit Date:** 2021-04-08
**Study First Submit QC Date:** 2021-04-08
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** McMaster University

#### Responsible Party

**Investigator Affiliation:** McMaster University

**Investigator Full Name:** Mark McRae

**Investigator Title:** Principal Investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

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

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 300

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** 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

**Name:** FACE-Q scale

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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

**Measure:** FACE-Q score

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** Patient photos may be taken post-op from the other studies and will be included if performed

**Measure:** Facial photos

**Time Frame:** 12 months

### Eligibility Module

**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

Exclusion Criteria:

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

**Healthy Volunteers:** True

**Maximum Age:** 100 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**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.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** Mcraem2@mcmaster.ca

**Name:** Mark McRae, MD

**Phone:** 905) 522-1155

**Phone Ext:** 32145

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hamilton

**Contacts:**

***Contact 1:***

- **Email:** Mcraem2@mcmaster.ca

- **Name:** Mark MccRa, MD

- **Phone:** (905) 522-1155

- **Phone Ext:** 32145

- **Role:** CONTACT

***Contact 2:***

- **Name:** Mark McRae, MD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Matthew McRae, MD

- **Role:** SUB_INVESTIGATOR

***Contact 4:***

- **Name:** Sophocles Voineskos, MD

- **Role:** SUB_INVESTIGATOR

***Contact 5:***

- **Name:** Minh Huynh, MD

- **Role:** SUB_INVESTIGATOR

**Country:** Canada

**Facility:** St. Joseph's Healthcare Hamilton

**State:** Ontario

**Status:** RECRUITING

**Zip:** L8N 4A6

#### Overall Officials

**Official 1:**

**Affiliation:** McMaster University

**Name:** Mark McRae, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000009369

- Term: Neoplasms

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: All

- Name: All Conditions

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M5550

- Name: Carcinoma, Squamous Cell

- Relevance: LOW

- As Found: Unknown

- ID: M5537

- Name: Carcinoma, Basal Cell

- Relevance: HIGH

- As Found: Basal Cell Skin Cancer

- ID: M15681

- Name: Skin Neoplasms

- Relevance: HIGH

- As Found: Skin Cancer

- ID: M21089

- Name: Facies

- Relevance: LOW

- As Found: Unknown

- ID: M20439

- Name: Neoplasms, Basal Cell

- Relevance: HIGH

- As Found: Cancer, Basal Cell

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000012878

- Term: Skin Neoplasms

- ID: D000002280

- Term: Carcinoma, Basal Cell

- ID: D000018295

- Term: Neoplasms, Basal Cell

### Misc Info Module

- Version Holder: 2024-05-24
