- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03290352
Pretreatment Quality of Life as a Predictor of Distant Metastasis-Free Survival and Overall Survival in Patients With Head and Neck Cancer
20. september 2017 opdateret af: Chia-Chin Lin, Taipei Medical University
Pretreatment Quality of Life as a Predictor of Distant Metastasis-Free Survival and Overall Survival in Patients With Head and Neck Cancer Who Underwent Free Flap Reconstruction
This study shed light on an under-researched area by examining the prognostic associations of pre-treatment QoL with overall survival and distant metastasis free survival among patients with head and neck cancer who underwent free flap reconstruction.
In addition, a validated instrument specific to head and neck cancer, i.e. the University of Washington Quality of Life Questionnaire (UW-QoL) was adopted.
Studieoversigt
Detaljeret beskrivelse
The importance of patient-related outcomes, especially quality of life (QoL) has been recently emphasized in the field of oncology.
In conjunction with traditional biomedical indicators, QoL is recognized as a reliable parameter to reflect the health status of patients with malignancy.
A growing body of evidence even points out that QoL can produce prognostic information which goes beyond biomedical indicators.
In particular, since QoL may decline before any possible deterioration in health can be detected by existing biomedical measures, assessing pre-treatment QoL possibly helps identify the patients who are susceptible to a higher risk of mortality after they receive cancer treatment, which may greatly facilitate the process of clinical decision making.
Despite the importance of pre-treatment QoL, its prognostic associations with overall survival and distant metastasis free survival still remain relatively under-explored.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
127
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Head and neck cancer patients undergoing free-flap reconstruction
Beskrivelse
Inclusion Criteria:
- Patients with oral cavity, tongue, gingival, pharyngeal, laryngeal, or salivary gland cancer and cervical lymph node metastasis, and
- Received free flap reconstruction between November 2010 and June 2014 at a medical university hospital
Exclusion Criteria:
- Patients with distant metastasis identified in their medical records, or
- Undergoing reconstruction other than anterolateral thigh, fibular bone and radial forearm flaps
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
Head and neck cancer patients
Patients with oral cavity, tongue, gingival, pharyngeal, laryngeal, or salivary gland cancer and cervical lymph node metastasis who received free flap reconstruction would be enrolled in this study.
However, we excluded the patients with distant metastasis identified in their medical records, and those undergoing reconstruction other than anterolateral thigh, fibular bone and radial forearm flaps.
|
Patients who enrolled in the study were asked to respond to the University of Washington Quality of Life Questionnaire one week before undergoing free flap reconstruction.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Overall survival of head and neck cancer patients with free-flap reconstruction
Tidsramme: 3 years 8 months
|
3 years 8 months
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
Distant metastasis free survival of head and neck cancer patients with free-flap reconstruction
Tidsramme: 3 years 8 months
|
3 years 8 months
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. november 2010
Primær færdiggørelse (Faktiske)
30. juni 2014
Studieafslutning (Faktiske)
30. juni 2015
Datoer for studieregistrering
Først indsendt
19. september 2017
Først indsendt, der opfyldte QC-kriterier
20. september 2017
Først opslået (Faktiske)
21. september 2017
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. september 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. september 2017
Sidst verificeret
1. september 2017
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HKU_1
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Uafklaret
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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