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Идёт набор NCT07605936

Frailty in Older Adults With Prostate Cancer: a Prospective Cohort Study

Наблюдательное Frailty at Older Adults Prostate Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Frailty at Older Adults, Prostate Cancer. Базовые параметры: от 65 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Ирландия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

A Prospective Cohort Study to Assess Frailty, Healthcare Needs and Health Related Quality of Life in Patients With a Diagnosis of Prostate Cancer

Обзор

Prostate cancer is the most common solid tumour cancer amongst men in Ireland, with almost 4,000 new cases diagnosed annually and a median age at diagnosis of 67 years. The incidence of frailty amongst cancer patients is high. Among patients undergoing systemic anti-cancer therapy, frailty increases the risk of treatment related toxicity, hospitalisation, and death and is associated with a poorer quality of life. This study aims to describe the demographic, clinical and frailty characteristics of men living with prostate cancer in the Mid-West of Ireland. In addition, we will assess the predictive accuracy of three frailty screening tools currently used in Irish clinical practice,G8, CFS and PRISMA 7, for predicting poorer outcomes at baseline, 6 and 12 months.

Подробное описание

Prostate cancer is the most common solid tumour cancer amongst men in Ireland, with almost 4,000 new cases diagnosed annually and a median age at diagnosis of 67 years. Whilst most men present with loco regional disease, 5-10% of men have metastatic disease at diagnosis and others develop metastatic disease later in life.

Frailty, a biologic syndrome of decreased reserve and resistance to stressors, resulting from cumulative declines across multiple physiologic systems, and causing vulnerability to adverse outcomes is also associated with increasing age. Both cancer and systemic anticancer therapies can act as significant stressors to the physiological reserve of patients and as a result, the incidence of frailty amongst older cancer patients is high. Among patients undergoing systemic anti-cancer therapy, frailty increases the risk of treatment related toxicity, hospitalisation, and death and is associated with a poorer quality of life.

The prevalence of frailty amongst men with prostate cancer appears to correlate to the extent of disease with the highest prevalence of frailty present in those with advanced metastatic disease. Treatment paradigms for advanced prostate cancer have evolved substantially, with early treatment intensification now considered the standard of care due to demonstrated overall survival benefits. However, treatment intensification, is associated with increased risk of toxicity and therefore poses a concern given the higher risk of competing mortality and morbidity amongst frail patients.

Functional status in oncology practice is predominantly assessed using the The Eastern Cooperative Oncology Group (ECOG) Performance Status Score or Karnofsky performance status which guide treatment decisions and predict treatment toxicity and overall survival .The limitations of these measures in the assessment of a heterogeneous population such as older adults, has been recognised. As such, it is recommended that a frailty assessment is undertaken for older patients and embedded into the decision-making regarding a patient's suitability for systemic anticancer therapy

A variety of frailty identification tools have been utilised in the oncology setting including: Clinical Frailty Score (CFS) , Geriatric 8 screening tool (G8) , Fried Frailty Phenotype and Vulnerable Elders Survey 13 (VES13) , with the G8 and VES being the most frequently used. Lower G8 scores have been associated with poorer oncological outcomes in older cancer patients while VES may demonstrate higher specificity for frailty prediction than G8 (as assessed by GCA). Although recommended and utilised clinically, frailty screening tools have yet to be validated for tailoring final anticancer treatment or frailty intervention plans.

This study aims to describe the demographic, clinical and frailty characteristics of men living with prostate cancer in the Mid-West of Ireland. Participants will be followed longitudinally over 12 months. In addition, we will assess the predictive accuracy of three frailty screening tools currently used in Irish clinical practice,G8, CFS and PRISMA 7, for predicting adverse outcomes at baseline, 6 and 12 months. The findings will provide important real-world insights into frailty, treatment practices, and patient-centred outcomes in prostate cancer, and may help inform future screening strategies and intervention studies

Первичные конечные точки

  • Functional status [Срок оценки: Baseline, six months and twelve months after index visit]
Вторичные конечные точки (3)
  • Patient quality of life [Срок оценки: Baseline, Six months and twelve months after index visit.]
  • Incidence of healthcare utilisation [Срок оценки: six months and 12 months following index visit]
  • Mortality [Срок оценки: six months and 12 months]

Критерии участия

Критерии включения

  • adults aged ≥65 years with a diagnosis of prostate cancer

Критерии исключения

  • Neither the patient nor the carer has sufficient proficiency in English sufficiently to complete consent or baseline assessment
  • Patients will be excluded if they present outside of research nurse (RN) operational hours( 8am and 5pm Monday - Friday).
  • Patients who are acutely unwell and unable to answer the questionnaire will also be excluded.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Ирландия · 1 центр
  • University Hospital Limerick — Limerick

Идентификаторы

NCT: NCT07605936 · 020/2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗