A Comparison of Skin Grafts Versus Local Flaps for Facial Skin Cancer From the Patient Perspective: A Feasibility Study

• Conditions: Skin Cancers - Squamous Cell Carcinoma; Patient Satisfaction; Skin Cancer; Skin Cancer, Basal Cell; Skin Cancer, Non-Melanoma
• Interventions: Other: FACE-Q patient reported outcome

• Registration Number: NCT04805905
• Lead Sponsor: McMaster University

Brief Summary

A prospective single-centered feasibility study will be conducted. The purpose of the feasibility study is to define the variables to be included in a subsequent pilot study, assess the feasibility of conducting a prospective cohort study, and the logistics for the study (i.e., training, patient recruitment, data collection, statistical analysis, etc.).

Detailed Description

A prospective single-centered feasibility study will be conducted. The purpose of the feasibility study is to define the variables to be included in a subsequent pilot study, assess the feasibility of conducting a prospective cohort study, and the logistics for the study (i.e., training, patient recruitment, data collection, statistical analysis, etc.).

Upon completion of the feasibility study, a prospective pilot cohort study would be performed to measure outcomes using the FACE-Q Skin Cancer module for patients receiving skin grafting or local flaps after excision of facial skin cancers.

Study Timeline

• Study First Submitted: 2021-02-01
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-16
• Last Update Submitted: 2021-03-16
• Study First Posted: 2021-03-18
• Last Update Posted: 2021-03-18
• Study Start: 2021-04
• Primary Completion: 2021-06
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients will be included in the study if:

• they are 18 years or older
• presenting for treatment of a suspected non-melanoma facial skin cancer, including pre-malignant cancers (i.e., actinic keratosis),
• and scheduled to undergo reconstruction with either a skin graft or local tissue flap.

Exclusion Criteria

Patients will be excluded in the study if they:

• present with altered level of consciousness,
• cannot provide consent,
• have facial nerve injury/previous facial nerve injury, have Melanoma skin cancer or Merkel cell carcinoma based on pathology reports, have polytrauma/multiple injuries, are pregnant, are undergoing free flap reconstruction, have bone involvement, or if they are under the age of 18.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Local flap	FACE-Q patient reported outcome	-
Skin graft	FACE-Q patient reported outcome	-

Primary Outcome Measures

Name	Time	Method
Recruitment rate	12 months	Percent of patients who are recruited for the feasibility study
Retention rate	3 months from surgery	The number of patients who complete the secondary outcomes (FACE-Q scores) at 3 months
Compliance rate	12 months	Compliance rate of patients receiving a treatment and completing the expected treated
Eligible patients	12 months	Percent of patients who meet eligibility criteria for the feasibility study

Secondary Outcome Measures

Name	Time	Method
FACE-Q score	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	12 months	Patient photos will be taken post-op at 2 weeks, 3 months, 6 months, and one-year post-operation, if feasible