Ignite Creation Date:
2024-05-06 @ 6:06 PM
Last Modification Date:
2024-10-26 @ 2:41 PM
Study NCT ID:
NCT05547594
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2022-09-12
Brief Title:
Prehabilitation in Patients With Cancer and Type 2 Diabetes
Sponsor:
University of Greenwich
Organization:
University of Greenwich
Study Overview
Official Title:
Impact of a Multimodal Prehabilitation Programme on Markers of Health Quality of Life and the Short and Long Post-surgery Recovery Period in Cancer Patients With Type 2 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 patients overall health and fitness so that they can better cope with the stress of surgery avoid complicationsreduce 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 ie 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 Baselineinitial assessment The participant will undergo a number of testsmeasurementsquestionnaires 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 testsmeasurementsquestionnaires 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 testsmeasurementsquestionnaires 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 testsmeasurementsquestionnaires 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 testsmeasurementsquestionnaires 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
Surgical prehabilitation refers to interventions done before surgery to increase the patients overall health and fitness so that they can better cope with the stress of surgery avoid complicationsreduce 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 ie 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 Baselineinitial assessment The participant will undergo a number of testsmeasurementsquestionnaires 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 testsmeasurementsquestionnaires 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 testsmeasurementsquestionnaires 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 testsmeasurementsquestionnaires 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 testsmeasurementsquestionnaires 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None