Skin Cancer, Basal CellNCT04805905
A Comparison of Skin Grafts Versus Local Flaps for Facial Skin Cancer From the Patient Perspective: A Feasibility Study
An observational study of Skin Cancer, Basal Cell and Skin Cancer, run by McMaster University.
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Cancer, Basal Cell, Skin Cancer, Skin Cancer, Non-Melanoma
- What is being tested?
- FACE-Q patient reported outcome
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this 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.).
Read the 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.
- Conditions
- Skin Cancer, Basal Cell, Skin Cancer, Skin Cancer, Non-Melanoma, Skin Cancers - Squamous Cell Carcinoma, Patient Satisfaction
- Being tested
- FACE-Q patient reported outcome
- Medical subject headings
- Carcinoma, Basal Cell, Skin Neoplasms, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FACE-Q patient reported outcomeOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Skin graft | Not described Receives: Other: FACE-Q patient reported outcome | |
| Local flap | Not described Receives: Other: FACE-Q patient reported outcome |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment rate
Percent of patients who are recruited for the feasibility study
Measured: 12 months
Retention rate
The number of patients who complete the secondary outcomes (FACE-Q scores) at 3 months
Measured: 3 months from surgery
Compliance rate
Compliance rate of patients receiving a treatment and completing the expected treated
Measured: 12 months
Eligible patients
Percent of patients who meet eligibility criteria for the feasibility study
Measured: 12 months
Secondary outcomes (2)
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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study startApr 2021 (estimated)
- Primary completionJun 2021 (estimated)
- Study completionFeb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin Cancer, Basal CellStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark McRae, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805905
- Sponsor's protocol ID
- 8304
- Status last verified
- Mar 2021
- First submitted
- 1 Feb 2021
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Skin Grafts Versus Local Flaps for Facial Skin Cancer From the Patient Perspective: A Feasibility Study
- ClinicalTrials.gov ID
- NCT04805905
- Acronym / sponsor ID
- 8304
- Conditions
- Skin Cancer, Basal Cell, Skin Cancer, Skin Cancer, Non-Melanoma, Skin Cancers - Squamous Cell Carcinoma, Patient Satisfaction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Jun 2021 (estimated)
- Study completion
- Feb 2022 (estimated)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Skin graft | – | Other: FACE-Q patient reported outcome |
| Local flap | – | Other: FACE-Q patient reported outcome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FACE-Q patient reported outcomeAs 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. | Other | Local flap, Skin graft |
Primary outcome
Recruitment rate
Time frame: 12 months
Percent of patients who are recruited for the feasibility study
Retention rate
Time frame: 3 months from surgery
The number of patients who complete the secondary outcomes (FACE-Q scores) at 3 months
Compliance rate
Time frame: 12 months
Compliance rate of patients receiving a treatment and completing the expected treated
Eligible patients
Time frame: 12 months
Percent of patients who meet eligibility criteria for the feasibility study
2 secondary outcomes
FACE-Q score
Time frame: 12 months
Facial photos
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Cancer, Basal Cell and Skin Cancer, run by McMaster University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mark McRae ((905) 522-1155 x32145 ext. 32145, Mcraem2@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment rate (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.