- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04805905
A Comparison of Skin Grafts Versus Local Flaps for Facial Skin Cancer From the Patient Perspective: A Feasibility Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Forventet)
Kontakter og lokationer
Studiekontakt
- Navn: Mark McRae
- Telefonnummer: 32145 (905) 522-1155 x32145
- E-mail: Mcraem2@mcmaster.ca
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Skin graft
|
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
|
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. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Recruitment rate
Tidsramme: 12 months
|
Percent of patients who are recruited for the feasibility study
|
12 months
|
Retention rate
Tidsramme: 3 months from surgery
|
The number of patients who complete the secondary outcomes (FACE-Q scores) at 3 months
|
3 months from surgery
|
Compliance rate
Tidsramme: 12 months
|
Compliance rate of patients receiving a treatment and completing the expected treated
|
12 months
|
Eligible patients
Tidsramme: 12 months
|
Percent of patients who meet eligibility criteria for the feasibility study
|
12 months
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
FACE-Q score
Tidsramme: 12 måneder
|
FACE-Q er et nyligt udviklet og valideret patientrapporteret resultatmål (PROM)-værktøj, der giver klinikere mulighed for at vurdere patientperspektiver efter hudkræftoperation i ansigtet. PROM'en bruges til at vurdere perspektivet og virkningen af hudkræft samt dens behandling på patientens livskvalitet (QoL).
Patienter med hudkræft kan have øget angst, social isolation og kosmetiske bekymringer efter operationen.
FACE-Q bruger fem skalaer til at måle psykometriske, livskvalitet, patientoplevelse og kosmetiske resultater.
Rå score omdannes til en 0-100 skala med en højere score, der indikerer et bedre resultat
|
12 måneder
|
Facial photos
Tidsramme: 12 months
|
Patient photos will be taken post-op at 2 weeks, 3 months, 6 months, and one-year post-operation, if feasible
|
12 months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 8304
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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