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
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 |
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.).
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
McMaster University |
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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