- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07594327
Quality of Life and Sexuality After Pelvic Exenteration for Gynecologic Cancer
Pelvic Exenteration as a Curative Option in Recurrent Gynecological Cancer: Oncological Outcomes and Impact on Quality of Life and Sexuality
Pelvic exenteration is an exceptionally extensive and very rare surgical procedure, most commonly used in the treatment of locally recurrent cervical cancer among gynecological malignancies. It is typically performed with curative intent when no other treatment options remain feasible.
The aim of this study is to examine the quality of life and sexuality of patients who have undergone pelvic exenteration.
This observational cross-sectional study utilizes internationally validated questionnaires assessing quality of life and sexual function: EORTC QLQ-C30, EORTC QLQ-CX24, and PISQ-12.
The findings of this study will provide important guidance for the selection and planning of pelvic exenteration. Improved understanding of postoperative quality of life will support patient selection and enable more comprehensive and individualized patient counseling.
Panoramica dello studio
Stato
Descrizione dettagliata
The investigators will invite living patients who have undergone pelvic exenteration for gynecological cancer at Tampere University Hospital since January 1, 2000, to participate in the study, provided that at least six months have elapsed since the surgery.
The patients are first contacted by telephone to inform them about the study. The investigators will then send an information letter regarding participation, along with questionnaires assessing quality of life and sexuality. There are 21 living patients, most of whom have had cervical cancer. Particular interest will be given to patients who have undergone neovaginal reconstruction, and additional sexuality-related questions have been developed specifically for these patients.
In addition, the medical records of all patients who have undergone pelvic exenteration for gynecological cancer since January 1, 2000, are retrospectively reviewed. Oncological outcomes after pelvic exenteration, factors affecting prognosis, and postoperative complications are assessed.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Luoghi di studio
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Tampere, Finlandia
- Tampere University Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- patient age over 18 years
- a diagnosis of gynecologic cancer
- having undergone exenteration surgery on or after January 1, 2000 (at least 6 months prior)
- the ability to read and write Finnish
Exclusion Criteria:
- cognitive and/or neurological disease that affects physical functioning and may therefore influence sexual functioning or make it difficult to respond to the questionnaire
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Self-reporterd quality of life measured by EORTC QLQ-C30 questionnaire
Lasso di tempo: Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration
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The EORTC QLQ-C30 is a 30-item questionnaire measuring the quality of life (QoL) of cancer patients, developed by the European Organisation for Research and Treatment of Cancer (EORTC).
It assesses physical, psychological, and social functioning.
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Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration
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Self-reporterd quality of life measured by EORTC QLQ-CX24 questionnaire
Lasso di tempo: Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration
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The EORTC QLQ-CX24 is a 24-item questionnaire, designed to assess disease-specific and treatment-specific aspects of quality of life in patients with cervical cancer.
It is developed by the European Organisation for Research and Treatment of Cancer (EORTC).
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Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration
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Self-reported sexuality assessed by the PISQ-12 questionnaire with additional study-specific questions
Lasso di tempo: Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration
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The PISQ-12 questionnaire is designed for patients with urinary incontinence or pelvic organ prolapse.
However, it also includes useful questions for patients undergoing pelvic exenteration.
In addition, the investigators have developed and included their own questions specifically tailored for patients with a neovagina.
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Cross-sectional at time of inclusion, at least 6 months after pelvic exenteration
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Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie genitali
- Neoplasie urogenitali
- Neoplasie per sede
- Neoplasie
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Malattie uterine
- Malattie genitali, femmina
- Neoplasie genitali, femmina
- Malattie della cervice uterina
- Neoplasie uterine
- Malattie vulvari
- Malattie vaginali
- Comportamento
- Comportamento sessuale
- Neoplasie cervicali uterine
- Neoplasie endometriali
- Neoplasie vulvari
- Neoplasie vaginali
- Sessualità
Altri numeri di identificazione dello studio
- R25065
Piano per i dati dei singoli partecipanti (IPD)
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Informazioni su farmaci e dispositivi, documenti di studio
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