An observational study in Bowel Cancer, sponsored by Doncaster And Bassetlaw Hospitals NHS Foundation Trust. Recruiting at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-08.
Sponsored by Doncaster And Bassetlaw Hospitals NHS Foundation Trust · Observational
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.
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.
178 studies on the registry are indexed under Intestinal Neoplasms; 21 are open to participants now.
This study's planned enrollment of 100 is below the median of 153 across 36 observational studies indexed under Intestinal Neoplasms.
Browse Intestinal Neoplasms studies →Doncaster And Bassetlaw Hospitals NHS Foundation Trust is the lead sponsor of 5 studies on the registry; 2 are open to participants now.
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Gastrointestinal cancer patients
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Exclusion Criteria:
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 be taken for baseline tests and metabolomic assessment. Participants who opt into having a digital motion device will also be shown how to use the device and will wear this for seven days. Written instructions to fit the device will also be given.
The sensitivity & specificity of digital motion data for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events
The development of biochemical assessments of frailty could also provide valuable information to guide the treatment of the older patient although there are very few that have been validated for clinical use across a range of settings.
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
A further potential measure of frailty is tissue levels of senescence. Senescent cells are rare in the tissues of young organisms but become more common as tissues age, especially in adipose tissue, muscle and skin (Tchkonia et al., 2010). Both ageing and frailty are associated with cellular senescence, a mechanism of irreversible cell cycle arrest caused by persistent stress and damage, which contributes to the process of ageing, frailty and a range of diseases (Xu et al., 2018; Hickson et al., 2019). Senescent cells are causal to a wide range of diseases such as arthritis, arteriosclerosis and dementia and are also linked to the development of frailty in animal models.
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
A simple, validated biomarker of frailty, capable of identification of patients who are at an increased risk of adverse outcomes from surgery, would be of great value in the surgical decision-making process.
Time frame: 01/12/2029
Blood biomarker correlation (baseline and post operative) with baseline frailty and poor outcomes (including length of stay and adverse events)
as above
Time frame: 01/12/2029
Adverse events related to surgery assessed CTCAE classifications
as above
Time frame: 01/12/2029
Tissue senescence correlation between baseline frailty and poor outcomes (including length of stay and adverse events)
as above
Time frame: 01/12/2029
Digital mobility outcomes correlation with baseline frailty and poor outcomes (including length of stay and adverse events)
as above
Time frame: 01/12/2029
Physical function assessment after surgery at 6 weeks, 3 months using the WHO DAS 2.0.
as above
Time frame: 01/12/2029
Quality of life at 6 weeks, 3 months after surgery using the EQ-5D-5L
as above
Time frame: 01/12/2029
Overall survival at 3 months and 5 years (the latter via cancer registry returns)
as above
Time frame: 01/12/2029
Plan to share: Undecided — TBC
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Doncaster And Bassetlaw Hospitals NHS Foundation Trust