Ignite Creation Date:
2024-05-06 @ 2:46 PM
Last Modification Date:
2024-10-26 @ 1:37 PM
Study NCT ID:
NCT04425616
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-22
First Post:
2020-06-03
Brief Title:
SafeFit Trial Virtual Clinics to Deliver Universal Interventions in People With Cancer
Sponsor:
University Hospital Southampton NHS Foundation Trust
Organization:
University Hospital Southampton NHS Foundation Trust
Study Overview
Official Title:
SafeFit Trial Virtual Clinics to Deliver Universal Interventions to Maintain and Improve Mental and Physical Health in People With Cancer Who Are Following Social Distancing Guidance A COVID-19 Targeted Trial
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-11
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:
Trial Phase Phase III Interventional Trial Virtual clinics to deliver universal interventions to maintain and improve physical health nutritional state and psychological wellbeing in people with cancer who are following social distancing guidance A COVID-19 targeted trial
Indication Male or female participants aged over 18 years old with suspicion or confirmed diagnosis of cancer does not require histological confirmation
Objective To investigate the efficacy of remote multimodal universal interventions delivered via virtual clinics to improve physical function as measured by the EORTC-QLQ-C30
Secondary Objective
To investigate the efficacy of remote multimodal universal interventions delivered via virtual clinics to improve emotional function quality of life participant activation PAM behaviour change and the effect it has on health economics EQ-5D-5L
Exploratory Objective
Overall Survival and adherence to the interventionadvice using validated tools or development of a web-based toolkit
Indication Male or female participants aged over 18 years old with suspicion or confirmed diagnosis of cancer does not require histological confirmation
Objective To investigate the efficacy of remote multimodal universal interventions delivered via virtual clinics to improve physical function as measured by the EORTC-QLQ-C30
Secondary Objective
To investigate the efficacy of remote multimodal universal interventions delivered via virtual clinics to improve emotional function quality of life participant activation PAM behaviour change and the effect it has on health economics EQ-5D-5L
Exploratory Objective
Overall Survival and adherence to the interventionadvice using validated tools or development of a web-based toolkit
Detailed Description:
Rationale A recent statement by Professor Chris Whitty Chief Medical Officer NHS England emphasised the significant benefits of exercise for all people He said this may be challenging for people self-isolating and even more so for those highly vulnerable people that are having to shield against the virus in their own homes The coronavirus COVID-19 pandemic has led to many changes to everyday life including the introduction of social distancing as well as restriction of travel Treatment plans for patients with cancer are being revised or modified due to risks and benefits of certain treatments in light of the COVID-19 risk The number of deaths due to the disruption in cancer services is likely to outweigh the number of deaths from coronavirus itself over the next five years
The effects of this pandemic has reportedly led to increased anxiety and distress and risks deconditioning due to reduced physical activity The interventions we are proposing aim to enable people with cancer to optimise their physical health nutritional state and psychological wellbeing and prepare for their treatment pathway current or modified and recovery during this uncertain time through exercise nutrition and psychological support
The aim is to investigate whether the promotion of these interventions delivered via virtual clinics in socially distanced people with cancer can improve physical and psychological function and self-efficacy to self-manage We are also aiming to evaluate health economics whilst following the COVID-19 government guidelines
Trial Design Phase III Non randomised Interventional Trial
Sample Size 1100
Intervention Provision of dietary exercise and psychological advice as well as behaviour change support universal interventions as aligned to the universal interventions with the caveats of COVID-19 in the Macmillan Principles and guidance for prehabilitation within the management and support of people with cancer guideline This complex intervention will be prescribed and delivered through virtual clinics where CanRehab professionals will support the individual Level 3 Personal Trainers may also deliver the interventions in some cases with a GP referral qualification and who are competent in delivering the interventions to participants with cancer post-treatment
The effects of this pandemic has reportedly led to increased anxiety and distress and risks deconditioning due to reduced physical activity The interventions we are proposing aim to enable people with cancer to optimise their physical health nutritional state and psychological wellbeing and prepare for their treatment pathway current or modified and recovery during this uncertain time through exercise nutrition and psychological support
The aim is to investigate whether the promotion of these interventions delivered via virtual clinics in socially distanced people with cancer can improve physical and psychological function and self-efficacy to self-manage We are also aiming to evaluate health economics whilst following the COVID-19 government guidelines
Trial Design Phase III Non randomised Interventional Trial
Sample Size 1100
Intervention Provision of dietary exercise and psychological advice as well as behaviour change support universal interventions as aligned to the universal interventions with the caveats of COVID-19 in the Macmillan Principles and guidance for prehabilitation within the management and support of people with cancer guideline This complex intervention will be prescribed and delivered through virtual clinics where CanRehab professionals will support the individual Level 3 Personal Trainers may also deliver the interventions in some cases with a GP referral qualification and who are competent in delivering the interventions to participants with cancer post-treatment
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