Assessing Frailty and Its Impacts on Patients Facing Major GI Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Frailty measure.
- Who it may be relevant to
- Registry conditions: Bowel Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Assessing Frailty and Its Impacts in Older Patients Facing Major Gastrointestinal Surgery
Overview
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.
Detailed description
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.
Interventions
- Other 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
Primary outcome measures
- The sensitivity & specificity of digital motion data for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events [Time frame: 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 [Time frame: 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 [Time frame: 01/12/2029]
Secondary outcome measures (7)
- Blood biomarker correlation (baseline and post operative) with baseline frailty and poor outcomes (including length of stay and adverse events) [Time frame: 01/12/2029]
- Adverse events related to surgery assessed CTCAE classifications [Time frame: 01/12/2029]
- Tissue senescence correlation between baseline frailty and poor outcomes (including length of stay and adverse events) [Time frame: 01/12/2029]
- Digital mobility outcomes correlation with baseline frailty and poor outcomes (including length of stay and adverse events) [Time frame: 01/12/2029]
- Physical function assessment after surgery at 6 weeks, 3 months using the WHO DAS 2.0. [Time frame: 01/12/2029]
- Quality of life at 6 weeks, 3 months after surgery using the EQ-5D-5L [Time frame: 01/12/2029]
- Overall survival at 3 months and 5 years (the latter via cancer registry returns) [Time frame: 01/12/2029]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Patients with unresectable cancer.
- Patients presenting as an emergency.
- Patients who are having chemotherapy or radiotherapy before their surgery.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United Kingdom · 1 center
- Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust — Doncaster
Identifiers
NCT: NCT06267378 · 1174/2022/NCTS