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

NCT04805905 | Unknown

• 1 other identifier: 8304
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.).

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• FACE-Q score

  12 months

• Facial photos

  12 months

Study Arms (2)

Skin graft

Other: FACE-Q patient reported outcome

Local flap

Other: FACE-Q patient reported outcome

Interventions

FACE-Q patient reported outcome OTHER

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; Skin graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead

MeSH Terms

Conditions

Carcinoma, Basal Cell; Skin Neoplasms; Patient Satisfaction

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Basal Cell; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Central Study Contacts

Mark McRae

CONTACT

(905) 522-1155 x32145; Mcraem2@mcmaster.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: March 18, 2021
• Study Start: April 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: February 1, 2022
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share