Trial Title:
Prehabilitation in Patients With Cancer and Type 2 Diabetes
NCT ID:
NCT05547594
Condition:
Cancer
Type 2 Diabetes
Conditions: Official terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Conditions: Keywords:
cancer
Type 2 diabetes
surgery
prehabilitation
recovery
exercise
nutrition
protein
anxiety
quality of life
physical performance
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Health Services Research
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Multimodal surgical prehabilitation
Description:
Participants will be encouraged to engage in regular physical activity (endurance and
resistance exercise), eat healthily and undergo cognitive behavioural therapy (the latter
only if required) during the weeks prior to surgery.
Arm group label:
Prehabilitation
Summary:
Surgical prehabilitation refers to pre-operative interventions aimed at increasing
patients' physiological reserve so that they can better cope with the stress of surgery,
avoid post-operative complications and have a faster recovery after surgery. Multimodal
prehabilitation combines different aspects related to a healthy lifestyle including but
not limited to; physical activity, nutritional education, anxiety coping strategies,
alcohol moderation and smoking cessation. Although these aspects are well known, having a
cancer diagnosis and the likelihood of an incoming operation during the weeks after
diagnosis, place patients in a situation where they may be more receptive to adopting
lifestyle changes aimed at promoting health. Such changes could be incorporated, not just
in the short-term in preparation for surgery, but also in the medium- and long-term,
improving patients' wellbeing and potentially reducing the risk of cancer reoccurrence
and other diseases.
Although the benefits of prehabilitation before surgery are understood, the effects it
may have in non-insulin-dependent Type 2 diabetes patients are unknown.
This project aims to: (i) Analyse the effects of a multimodal prehabilitation programme
vs. the current National Health Service (NHS) standard approach, on physical performance
in cancer patients with non-insulin-dependent Type 2 diabetes prior to surgery. (ii)
Explore the impact of the programme on body composition and metabolic markers. (iii)
Analyse the programme adherence, markers of well-being and quality of life during a
post-surgery period of up to 12 months as well as its effects on clinical outcomes.
Detailed description:
This study will take advantage of already existing infrastructures, by approaching a
single National Health Service (NHS) hospital in England that is already run a
prehabilitation service for its patients. This study will analyse the effect of the
prehabilitation programme on a specific group of patients, those with cancer and Type 2
diabetes who do not require insulin as part of their diabetes treatment and who are
waiting for surgery.
Surgical prehabilitation refers to interventions done before surgery to increase the
patient's overall health and fitness so that they can better cope with the stress of
surgery, avoid complications/reduce, and have a faster recovery after surgery. Multimodal
prehabilitation combines different aspects related to a healthy lifestyle, including but
not limited to; physical activity, nutritional education, anxiety coping strategies,
alcohol moderation and smoking cessation.
Multimodal prehabilitation programmes may use a combination of telehealth and
face-to-face delivery to provide flexibility according to the preferences of the
patients.
The collaboration between the University of Greenwich and NHS will provide an opportunity
to measure the impact of the programme on those participants with Type 2 diabetes, beyond
variables like weight and fasting blood glucose (i.e., body composition, glycaemic
behaviour, blood insulin concentration, immune system markers...).
The hospital prehabilitation team will identify potential study participants (patients
with Type 2 diabetes who do not use insulin awaiting surgery) amongst those referred to
their service. The prehabilitation team will present the idea of the study to the
potential participants and will ask for consent to share their contact details with the
sponsor. If consent is received, the researcher will contact them to briefly present to
them the possibility of joining the study. This 1st contact will be overseen by the Chief
Investigator.
Those who accept to participate in the study will be allocated into 2 different groups.
Patients undergoing prehabilitation will join the prehabilitation group of the study,
while those declining prehabilitation will join the control group.
Regardless of the group, all patients will undergo the same number of interactions with
the researcher:
1. Interview and consent The candidate will be provided with the patient information
sheet and explained what they can expect and what will be expected from them if they
decide to participate in the study. Candidates will be able to ask questions and, in
case they decide to participate, they will sign the participant consent form.
2. Baseline/initial assessment The participant will undergo a number of
tests/measurements/questionnaires to obtain information on their physical
performance quality of life, body composition, glycaemic markers and immune system
markers.
This assessment will take place a few weeks before surgery before the patient starts
prehabilitation (prehab group) or upon joining the study (control group).
3. Assessment before surgery The participant will undergo a number of
tests/measurements/questionnaires to obtain information on their physical
performance quality of life, body composition, glycaemic markers and immune system
markers.
This assessment will take place a few days before surgery.
4. Assessment 6 weeks after surgery The participant will undergo a number of
tests/measurements/questionnaires to obtain information on their physical
performance quality of life, body composition, glycaemic markers and immune system
markers.
This assessment will take place 6 weeks after surgery, a time that generally allows
the participant to recover enough to be able to move around comfortably and perform
some light physical activity
5. Assessment 6 months after surgery The participant will undergo a number of
tests/measurements/questionnaires to obtain information on their physical
performance quality of life, body composition, glycaemic markers and immune system
markers.
This assessment will take place 6 months after surgery, a time by which the patient
will generally be fully recovered, potentially reaching their pre-surgical status,
and will have been able to resume their regular day-to-day activity
6. Assessment 12 months after surgery The participant will undergo a number of
tests/measurements/questionnaires to obtain information on their physical
performance quality of life, body composition, glycaemic markers and immune system
markers.
Both groups (prehabilitation and control) will undergo the same previously described
assessments. This will allow us to understand and compare how the measured variables
change through time in both groups (prehabilitation vs control).
The investigators hypothesise that prehabilitation will improve patients' physical
performance prior to surgery and will provide them with a range of tools to help them
recover faster and manage their overall health better (including their diabetes control)
for at least one year after surgery.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Capacity to give consent
- Newly diagnosed with cancer
- Non-insulin-dependent Type 2 diabetes
- Awaiting surgery for cancer
Exclusion Criteria:
- Medical contraindication to engage in physical activity
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
School of Human Sciences, University of Greenwich, Avery Hill Campus, Sparrows Farm (Office SF112B)
Address:
City:
Eltham
Zip:
SE9 2BT
Country:
United Kingdom
Status:
Not yet recruiting
Contact:
Last name:
Fernando Naclerio, PhD
Phone:
0044 2083 318441
Email:
f.j.naclerio@greenwich.ac.uk
Contact backup:
Last name:
Roberto Laza-Cagigas, MSc
Phone:
0044 7597 058406
Email:
r.lazacagigas@greenwich.ac.uk
Investigator:
Last name:
Ian Swaine, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Marcos Seijo, PhD
Email:
Sub-Investigator
Investigator:
Last name:
Roberto Laza-Cagigas, PhD
Email:
Sub-Investigator
Facility:
Name:
King's College Hospital
Address:
City:
London
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Roberto Laza, PhD/MPhil
Email:
R.LazaCagigas@greenwich.ac.uk
Start date:
January 18, 2024
Completion date:
April 30, 2025
Lead sponsor:
Agency:
University of Greenwich
Agency class:
Other
Source:
University of Greenwich
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05547594
