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Assessing Frailty and Its Impacts on Patients Facing Major GI Surgery

Sponsor: Doncaster And Bassetlaw Hospitals NHS Foundation Trust

NCT ID: NCT06267378

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Health checks and monitoring — no treatment given
Type of study
Observational (no treatment given)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Frailty measure (other)
How long the study runs
Study runs about 76 months (dates as stated)
About the drug or intervention
Frailty measure — other: All participants will be asked to complete baseline assessments and a blood test.
Patient visit burden
Not specified by the sponsor
Type of study
Observing health over time
Ages
18 Years and over
Who
All
Number of participants
100
Started
2023-08-30
Last checked
2023-10

Plain English Summary

What is this study?

  • • Testing a new treatment for bowel cancer
  • • Clinical study - 100 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with bowel cancer

Where?

  • • Doncaster - Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

Bowel Cancer

How this trial compares with your answers

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What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

Still need:

  • • Tell us your age for better matching
  • • Tell us your sex for better matching

Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

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

Who cannot take part

  • ✗Patients with unresectable cancer.
  • ✗Patients presenting as an emergency.
  • ✗Patients who are having drug treatment or radiotherapy before their surgery.
See the full 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.

Where Is This Study? (1 UK site)

Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

Doncaster DN2 5LT, United Kingdom

Recruiting
Site contact (verified)
Doncaster Royal Infirmarydbth.clinicalresearch@nhs.net

How to Get in Touch

Jayan George

Sponsor contact

CONTACT

01302 366666 jayan.george@nhs.net

Emma Stoner

Sponsor contact

CONTACT

01302 644073 dbth.clinicalresearch@nhs.net
Data sourced from ClinicalTrials.gov · Last verified: 2023-10