Clinical trial NCT06267378: Assessing Frailty and Its Impacts on Patients Facing Major GI Surgery
Official title: Assessing Frailty and Its Impacts in Older Patients Facing Major Gastrointestinal Surgery
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Bowel Cancer
Lead sponsor: Doncaster And Bassetlaw Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Gastrointestinal cancer patients

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Patients with unresectable cancer.
2. Patients presenting as an emergency.
3. Patients who are having chemotherapy or radiotherapy before their surgery.

Primary outcomes:
measure: The sensitivity & specificity of digital motion data for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events
timeFrame: 01/12/2029
measure: The sensitivity & specificity of tissue senescence for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events
timeFrame: 01/12/2029
measure: The sensitivity & specificity of blood based biomarkers for the prediction of baseline clinical frailty levels & post-operative measures of frailty, mortality and adverse events
timeFrame: 01/12/2029
Secondary outcomes:
measure: Blood biomarker correlation (baseline and post operative) with baseline frailty and poor outcomes (including length of stay and adverse events)
timeFrame: 01/12/2029
measure: Adverse events related to surgery assessed CTCAE classifications
timeFrame: 01/12/2029
measure: Tissue senescence correlation between baseline frailty and poor outcomes (including length of stay and adverse events)
timeFrame: 01/12/2029
measure: Digital mobility outcomes correlation with baseline frailty and poor outcomes (including length of stay and adverse events)
timeFrame: 01/12/2029
measure: Physical function assessment after surgery at 6 weeks, 3 months using the WHO DAS 2.0.
timeFrame: 01/12/2029
measure: Quality of life at 6 weeks, 3 months after surgery using the EQ-5D-5L
timeFrame: 01/12/2029
measure: Overall survival at 3 months and 5 years (the latter via cancer registry returns)
timeFrame: 01/12/2029
Other outcomes:
Locations:
city: Doncaster
country: United Kingdom
facility: Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
state: South Yorkshire
Study officials:
affiliation: Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust
name: Jayan George
role: PRINCIPAL_INVESTIGATOR
References: