Assessing Frailty and Its Impacts on Patients Facing Major GI Surgery

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

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.

Study Overview

• Status: Recruiting
• Conditions: Bowel Cancer
• Intervention / Treatment: Other: Frailty measure

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Jayan George; Phone Number: 01302 366666; Email: jayan.george@nhs.net
• Study Contact Backup: Name: Emma Stoner; Phone Number: 01302 644073; Email: dbth.clinicalresearch@nhs.net

Study Locations

• United Kingdom
  • South Yorkshire
    • Doncaster, South Yorkshire, United Kingdom, DN2 5LT
      • Recruiting
      • Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
      • Contact: Doncaster Royal Infirmary; Email: dbth.clinicalresearch@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Gastrointestinal cancer patients

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	01/12/2029

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Doncaster And Bassetlaw Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Jayan George, Doncaster & Bassetlaw Teaching Hospitals NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: October 24, 2023
• First Submitted That Met QC Criteria: February 12, 2024
• First Posted (Actual): February 20, 2024

Study Record Updates

• Last Update Posted (Actual): July 8, 2024
• Last Update Submitted That Met QC Criteria: July 5, 2024
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: 1174/2022/NCTS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: TBC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No