Pilotundersøgelse af håndtering af ansigtslammelse hos onkologisk patient: nerveoverførselsteknikker til forbedring af ansigtsfunktion og livskvalitet
The goal of this research study is to measure changes in patients' quality of life after surgeries that affect the facial nerve, including nerve transfer as treatment for facial paralysis.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Primary Objective:
To evaluate the impact of facial nerve transfer techniques (FNTT) on QoL in head and neck cancer patients with facial paralysis. This study intends to measure the impact of FNTT on QoL utilizing a series of validated questionnaires which include: (i) Facial Clinimetric Evaluation Scale and Facial Disability Index; (ii) Sunnybrook Facial Grading System; and (iii) Facial Nerve Grading Scale 2.0. These instruments will be administered at baseline, after surgery, and at 6, 12, and 18 months post-operatively.
Secondary Objective:
To compare patient-reported outcomes and facial function scales for patients who undergo facial nerve transfer technique with a historical cohort of patients who did not undergo any dynamic nerve reconstruction procedures. The same assessment tools described in primary objective above will be utilized.
To explore if qualitative observable visual differences are reflected in the Sunnybrook Grading Scale using photos and videos.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Z-Hye Lee, MD
- Telefonnummer: 713-563-4598
- E-mail: zlee@mdanderson.org
Studiesteder
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- Rekruttering
- The University of Texas M. D. Anderson Cancer Center
-
Kontakt:
- Z-Hye Lee, MD
- Telefonnummer: 713-563-4598
- E-mail: zlee@mdanderson.org
-
Ledende efterforsker:
- Z-Hye Lee, MD
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
In order to be eligible to participate in the intervention group of this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Aged 18 or greater
- Patient scheduled to undergo facial nerve transfer
- Stated willingness to comply with all study procedures and lifestyle considerations and availability for the duration of the study
In order to be eligible to participate in the non-intervention historical control group of this study, an individual must meet all of the following criteria:
- Provision of signed and dated informed consent form
- Aged 18 or greater
- Previous facial surgery severing a facial nerve without graft or other form of dynamic facial nerve reconstruction within the last 20 years
Exclusion Criteria:
Patients known to be pregnant
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Ikke-randomiseret
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Kirurgi
|
Participants will undergo facial nerve reconstruction using nerve transfer techniques |
|
Eksperimentel: Control
Participants will be identified and recruited during their visit to the Center of Reconstructive Surgery. |
Participants will undergo facial nerve reconstruction using nerve transfer techniques |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Safety and Adverse Events (AEs)
Tidsramme: Through study completion; an average of 1 year
|
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 |
Through study completion; an average of 1 year
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Z-Hye Lee, MD, M.D. Anderson Cancer Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
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
- 2024-1315
- NCI-2024-09091 (Anden identifikator: NCI-CTRP Clinical Trials Registray)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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