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

Patient Satisfaction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04805905
• Other study ID #: 8304
• Status: Not yet recruiting
• Start date: April 2021
• Est. completion date: February 2022

Study information

• Verified date: March 2021
• Source: McMaster University
• Contact: Mark McRae
• Phone: (905) 522-1155 x32145
• Email: Mcraem2[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 2022
• Est. primary completion date: June 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Outcome

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