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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04805905
Other study ID # 8304
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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