Идёт набор NCT06267378

Assessing Frailty and Its Impacts on Patients Facing Major GI Surgery

— Наблюдательное Bowel 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: В протоколе указаны: Frailty measure.
Кому может быть актуально: Состояния в реестре: Bowel Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Великобритания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Assessing Frailty and Its Impacts in Older Patients Facing Major Gastrointestinal Surgery

Обзор

The study team will look at 3 new tests that will make it easier to measure frailty in patients awaiting surgery for cancer and compare them against standard clinical measures of frailty in a pilot study. The expected outcome is that evidence will be collated in order to apply for a major grant to look at improving the care of frail patients with cancer in the future.

Подробное описание

Over 40% of patients with bowel cancer are over the age of 75. In older patients, rates of ill health and frailty are high, with frailty found in 6 in 10 patients over the age of 90. Surgery is the main treatment for bowel cancer, but the risks of surgery are higher in older people especially if they are frail. The main features of frailty are weight loss, lack of energy, weakness, slow walking speed and low activity levels. Frailty is a condition linked to an increased risk of death and major complications after surgery. As a result, older and frailer patients are often refused surgery for their cancer. If we could identify frailty more reliably before surgery, we could offer patients better counselling about the surgical risks and benefits. We could also offer treatments that might improve their fitness, making the surgery safer (pre-operative exercise, better post-operative support). Surgeons are not very good at measuring frailty because the clinical tests for it are complicated and take a long time to complete.

Вмешательства

Другое Frailty measure
All participants will be asked to complete baseline assessments and a blood test. 30 participants out of the 100 will be selected to wear a digital motion device before their surgery for seven days. (15 participants will be non-frail and 15 patients will be frail). Where possible, all baseline assessments will be scheduled to coincide with a routine clinic/hospital visit. The first assessment will complete functional, frailty, nutritional, and quality of life questionnaires. A blood test will

Первичные конечные точки

The sensitivity & specificity of digital motion data for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events [Срок оценки: 01/12/2029]
The sensitivity & specificity of tissue senescence for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events [Срок оценки: 01/12/2029]
The sensitivity & specificity of blood based biomarkers for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events [Срок оценки: 01/12/2029]

Вторичные конечные точки (7)

Blood biomarker correlation (baseline and post operative) with baseline frailty and poor outcomes (including length of stay and adverse events) [Срок оценки: 01/12/2029]
Adverse events related to surgery assessed CTCAE classifications [Срок оценки: 01/12/2029]
Tissue senescence correlation between baseline frailty and poor outcomes (including length of stay and adverse events) [Срок оценки: 01/12/2029]
Digital mobility outcomes correlation with baseline frailty and poor outcomes (including length of stay and adverse events) [Срок оценки: 01/12/2029]
Physical function assessment after surgery at 6 weeks, 3 months using the WHO DAS 2.0. [Срок оценки: 01/12/2029]
Quality of life at 6 weeks, 3 months after surgery using the EQ-5D-5L [Срок оценки: 01/12/2029]
Overall survival at 3 months and 5 years (the latter via cancer registry returns) [Срок оценки: 01/12/2029]

Критерии участия

Критерии включения

Male or female.
Aged 70 years and over.
Patients with a diagnosis of primary operable colorectal cancer where treatment includes a planned curative surgical procedure.
About to undergo elective surgery for cancer.
Mental capacity to consent.