Assessing Frailty and Its Impacts on Patients Facing Major GI Surgery

Trial Title: Assessing Frailty and Its Impacts on Patients Facing Major GI Surgery

NCT ID: NCT06267378

Condition: Bowel Cancer

Conditions: Official terms:
Frailty

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: Frailty measure
Description: 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.

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.

Criteria for eligibility:

Study pop:
Gastrointestinal cancer patients

Sampling method: Probability Sample
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.

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

Address:
City: Doncaster
Zip: DN2 5LT
Country: United Kingdom

Status: Recruiting

Contact:
Last name: Doncaster Royal Infirmary
Email: dbth.clinicalresearch@nhs.net

Start date: August 30, 2023

Completion date: December 1, 2029

Lead sponsor:
Agency: Doncaster And Bassetlaw Hospitals NHS Foundation Trust
Agency class: Other

Source: Doncaster And Bassetlaw Hospitals NHS Foundation Trust

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06267378