Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Feasibility of Frailty Assessment and Implementation of Interventions in Women Over 70 With Epithelial Ovarian Cancer (FAIR-O)

6 marzo 2020 aggiornato da: Royal Marsden NHS Foundation Trust

Feasibility of Frailty Assessment and Implementation of Protocol-led Geriatric Interventions in Women Over the Age of 70 With Epithelial Ovarian Cancer in the Oncology Clinic (FAIR-O)

Ovarian cancer is frequently diagnosed in older women, with over half of all new diagnoses being in women over 65 years. Current treatment options are based on the results of clinical trials that often do not include older, less fit patients in whom treatments may be less well tolerated. Further, in older patients the impact of complex medical and social issues is not known. The UK lags behind Europe and the United States in the development of research programs dedicated to improving outcomes for older patients. More research focus is urgently required to improve the assessment and management of older women with ovarian cancer to improve survival outcomes, quality of life and functional independence.

Current treatment decisions are made predominantly on age and fitness. However, it has been shown that undertaking a holistic, geriatric assessment of older patients can highlight important issues that would not necessarily be identified in a routine oncology appointment. In this study, we propose to ask oncology teams to undertake a geriatric assessment and specifically address issues that may arise as a result of this. The assessment comprises 8 simple non-invasive assessments that can be performed in the out-patient setting.

This approach could result in an important change in clinical practice leading to more holistic assessment of older cancer patients and better address their specific needs and manage their cancer treatment. The long-term goal is to show that pro-actively managing potential issues at the beginning of treatment allows patients to tolerate treatment and maintain their functional independence, leading to improved quality of life.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

FAIR-O is a single-arm, multi-center, phase II intervention trial of a geriatric assessment in older patients (≥ 70 years old) diagnosed with epithelial ovarian, fallopian tube or primary peritoneal cancer. Patients will be approached if they are being considered for systemic chemotherapy either as neoadjuvant / front-line chemotherapy in the first-line setting OR for chemotherapy at first relapse.

Two cohorts of patients will be recruited and run in parallel (no comparison will be performed between them):

  1. First-line cohort: patients with newly diagnosed advanced (stage III/IV) ovarian cancer who have received no prior treatment for ovarian cancer including surgery.
  2. First relapse cohort: ovarian cancer patients with first relapse

On consenting to the trial, a comprehensive medical and treatment history will be obtained including blood tests, tumour markers and a CT scan. The CT scan will be assessed for extent (volume) of muscle mass and compared to reference standards to identify patients with low muscle attenuation and sarcopenia (i.e. loss of muscle mass).

In addition, consented patients will be asked to undertake a comprehensive Geriatric Assessment which comprises a collection of 8 tests - all of which are non-invasive. These test comprise validated questionnaires and functional assessments including the G8 questionnaire, independent activities of daily living (IADL), activities of daily living (ADL), Charlson co-morbidity score, Hospital anxiety and depression scale (HADS), mini nutritional assessment (MNA), a timed up-and-go test and a mini cognitive assessment.

The Geriatric Assessment will enable the treating clinical team to determine whether the patient has specific deficits or problems which need further specialist attention with the aim of ensuring maximum tolerance to chemotherapy treatment. A Study Algorithm will guide the clinician to the most appropriate actions. These actions may include referral to other specialist services or referral for specific diagnostic tests. The number and type of referrals and the time taken for that referral to be performed will be captured.

Following the initial assessment in clinic, patients will will continue to attend standard treatment chemotherapy clinics. Their response to treatment will be recorded including the emergence of symptoms of study interest. Throughout the study decisions regarding systemic chemotherapy including regimen choice, dose modifications and supportive medications will be the responsibility of the treating oncologist and will not be determined by the outcome of the Geriatric Assessment.

Patients will be recruited until 60 patients have been recruited to each cohort. Patients will be followed-up until the end of the study which will be defined as 12 months from study entry or disease progression or death, whichever comes soonest.

The feasibility of introducing the Geriatric Assessment into the standard of care chemotherapy pathway is the primary end point of the study and will be statistically assessed. The number of fully completed assessments that the Research Team are able to conduct in the predicted target of 120 patients recruited to the trial will determine the feasibility on introducing the Geriatric Assessment to routine oncology clinics for this patient cohort.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

120

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

70 anni e precedenti (Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Femmina

Descrizione

Inclusion Criteria:

  • Age at time of consideration for systemic chemotherapy of 70 years and above
  • Histological or cytological confirmation of epithelial ovarian cancer
  • Planning to commence systemic chemotherapy for either newly diagnosed epithelial ovarian cancer or first disease relapse
  • Life expectancy greater than 3 months
  • Able to give informed consent, complete questionnaires in english and comply with study procedures

Exclusion Criteria:

  • In the opinion of the investigator, patient is not fit for systemic chemotherapy or patient declines systemic chemotherapy
  • Patient does not have the capacity to consent for enrollment into the study or capacity to consent for systemic chemotherapy

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Altro: Ovarian cancer patients over 70 years receiving chemotherapy
Patients with ovarian cancer receiving chemotherapy as either first line treatment (i.e. newly diagnosed advanced stage III/IV cancer) or at first relapse. Patients to receive a Geriatric Assessment including interventions for functional or other identified deficits and appropriate specialist algorithm-determined interventions.
Altro: Functional Geriatric Assessment
A series of 8 self-completed questionnaires for the identification of functional deficits which will be addressed via algorithm-guided interventions and assessments.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Feasibility of completing the Functional Geriatric Assessment
Lasso di tempo: Obtained at Baseline (Date of Consent)
Proportion of patients in whom it was possible to complete the Functional Geriatric assessment within the Oncology Clinic setting, assessed at the point of the first oncology clinic visit.
Obtained at Baseline (Date of Consent)

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Proportion of patients with deficits identified resulting in algorithm defined interventions
Lasso di tempo: Obtained at Baseline (Date of Consent)
The number of deficits identified through use of the Functional Geriatric Assessment resulting in algorithm defined interventions including clinical referrals or assessments as identified during the first oncology clinic visit.
Obtained at Baseline (Date of Consent)
Proportion of patients developing sarcopenia during chemotherapy treatment, amounting to an average of 6 months on chemotherapy treatment.
Lasso di tempo: Baseline (Date of Consent) to date of last chemotherapy treatment, an average of 6 months.
The number of patients assessed as sarcopenic as assessed via routine computerized tomography scans conducted at baseline, mid-treatment and the end of treatment.
Baseline (Date of Consent) to date of last chemotherapy treatment, an average of 6 months.
Proportion of patients with grade 3/4 hematological and non-hematological toxicities
Lasso di tempo: Baseline (date of Consent) to date of last chemotherapy treatment, an average of 6 months.
The number of patients experiencing Grade 3 or 4 hematological and non-hematological toxicities using the Common Terminology Criteria for Adverse Events (CTCAE) assessed through chemotherapy treatment from the start of treatment, mid-way through treatment and at the end of treatment, an average time-frame of 6 months.
Baseline (date of Consent) to date of last chemotherapy treatment, an average of 6 months.
Time on chemotherapy treatment
Lasso di tempo: Start date of chemotherapy treatment to date of discontinuation of treatment, an average of 6 months.
The length of time in months and days that the patient remains on routine chemotherapy treatment, an average of 6 months.
Start date of chemotherapy treatment to date of discontinuation of treatment, an average of 6 months.
Quality of Life Outcome score in Cancer Patients
Lasso di tempo: Start date of chemotherapy treatment, through treatment (average of 6 months) and at months 3, 6, 9, and 12 after date of last delivery of chemotherapy treatment.
Quality of Life measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30. Maximum (worst) score: 112 and minimum (best) score: 28
Start date of chemotherapy treatment, through treatment (average of 6 months) and at months 3, 6, 9, and 12 after date of last delivery of chemotherapy treatment.
Quality of Life Outcome score in Ovarian Cancer Patients
Lasso di tempo: Start date of chemotherapy treatment, through treatment (average of 6 months) and at months 3, 6, 9, and 12 after date of last delivery of chemotherapy treatment.
Quality of Life measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire in Ovarian Cancer Patients (QLQ OV) 28. Maximum (worst) score: 112 and minimum (best) score: 28
Start date of chemotherapy treatment, through treatment (average of 6 months) and at months 3, 6, 9, and 12 after date of last delivery of chemotherapy treatment.
Quality of Life Outcome score in Elderly Cancer Patients
Lasso di tempo: Start date of chemotherapy treatment, through treatment (average of 6 months) and at months 3, 6, 9, and 12 after date of last delivery of chemotherapy treatment.
Quality of Life measured using the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire in Elderly Cancer Patients (QLQ ELD) 14. Maximum (worst) score: 56 and minimum (best) score: 14
Start date of chemotherapy treatment, through treatment (average of 6 months) and at months 3, 6, 9, and 12 after date of last delivery of chemotherapy treatment.
Sarcopenia and frailty
Lasso di tempo: Assessed between baseline (date of Consent) mid-way though chemotherapy treatment to the date of delivery of last chemotherapy treatment, an average of 6 months.
Sensitivity and specificity of sarcopenia in identifying frailty as identified by the Functional Geriatric Assessment
Assessed between baseline (date of Consent) mid-way though chemotherapy treatment to the date of delivery of last chemotherapy treatment, an average of 6 months.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Royal Marsden NHS Foundation Trust

Investigatori

  • Investigatore principale: Susana Banerjee, MBBS MA FRCP, Royal Marsden NHS Foundation Trust

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Anticipato)

1 giugno 2020

Completamento primario (Anticipato)

1 dicembre 2021

Completamento dello studio (Anticipato)

1 dicembre 2022

Date di iscrizione allo studio

Primo inviato

2 marzo 2020

Primo inviato che soddisfa i criteri di controllo qualità

6 marzo 2020

Primo Inserito (Effettivo)

9 marzo 2020

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 marzo 2020

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 marzo 2020

Ultimo verificato

1 novembre 2019

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • CCR 5138
  • RG2165 (Altro numero di sovvenzione/finanziamento: Wellbeing of Women)

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Qualità della vita

Prove cliniche su Functional Geriatric Assessment

Cerca prove simili

Sponsor e collaboratori

Condizioni mediche

Interventi farmacologici

CROs by country

CROs in Ecuador

Condizioni

Malattie rare

Interventi farmacologici

Supplementi dietetici

Sponsor / Collaboratori

Sedi

Sottoscrivi