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

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.).

Study Overview

• Status: Not yet recruiting
• Conditions: Skin Cancer; Patient Satisfaction; Skin Cancer, Basal Cell; Skin Cancer, Non-Melanoma; Skin Cancers - Squamous Cell Carcinoma
• Intervention / Treatment: Other: FACE-Q patient reported outcome

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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Mark McRae; Phone Number: 32145 (905) 522-1155 x32145; Email: Mcraem2@mcmaster.ca

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

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. 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Skin graft	Other: FACE-Q patient reported outcome; As both interventions of treatment are gold standards and clinical equipoise exists if one intervention is superior to the other, there is no true control group. However, for the purpose of the application, the local flap group will be chosen as the "control" group. Skin graft (Experimental): Participants in the experimental group will receive a skin graft and receive the FACE-Q skin cancer questionnaire pre- and post-treatment. There will also be photos taken of the patient's face along with the distributed questionnaires. Local flap (Control): Participants in the experimental group will receive a local flap and receive the FACE-Q questionnaire pre- and post-treatment.
Local flap	Other: FACE-Q patient reported outcome; As both interventions of treatment are gold standards and clinical equipoise exists if one intervention is superior to the other, there is no true control group. However, for the purpose of the application, the local flap group will be chosen as the "control" group. Skin graft (Experimental): Participants in the experimental group will receive a skin graft and receive the FACE-Q skin cancer questionnaire pre- and post-treatment. There will also be photos taken of the patient's face along with the distributed questionnaires. Local flap (Control): Participants in the experimental group will receive a local flap and receive the FACE-Q questionnaire pre- and post-treatment.

What is the study measuring?

Primary Outcome Measures

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

Secondary 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
Facial photos	Patient photos will be taken post-op at 2 weeks, 3 months, 6 months, and one-year post-operation, if feasible	12 months

Collaborators and Investigators

• Sponsor: McMaster University

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2021
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): February 1, 2022

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Skin Neoplasms; Neoplasms, Basal Cell
• Other Study ID Numbers: 8304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No