Clinical trial NCT04425616: SafeFit Trial: Virtual Clinics to Deliver Universal Interventions in People With Cancer
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cancer
COVID
Keywords: COVID-19
Virtual clinics
Exercise
Cancer diagnosis
Nutrition
Psychological support
Behaviour change
Lead sponsor: University Hospital Southampton NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Macmillan Cancer Support
name: CanRehab Trust
name: Wessex Cancer Alliance
First posted: 2020-06-11
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non-randomised phase III interventional trial
Primary purpose: TREATMENT

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 intervention/advice 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.

Eligibility criteria: Inclusion Criteria:

* Male or female participants, aged over 18 years old
* Suspicion or confirmed diagnosis of cancer (does not require histological confirmation)

Exclusion Criteria:

- Participants unable to give informed consent

Primary outcomes:
measure: Physical Function
timeFrame: Baseline up to 1 year post enrolment
Secondary outcomes:
measure: Emotional Function
timeFrame: Baseline up to 1 year post enrolment
measure: Health related quality of life
timeFrame: Baseline up to 1 year post enrolment
measure: Health economics analysis
timeFrame: Baseline up to 1 year post enrolment
measure: Patient activation
timeFrame: Baseline up to 1 year post enrolment
measure: Self-reported physical activity
timeFrame: Baseline up to 1 year post enrolment
measure: Nutrition assessment
timeFrame: Baseline up to 1 year post enrolment
measure: Self-efficacy for self-management of chronic disease
timeFrame: Baseline up to 1 year post enrolment
measure: Distress levels
timeFrame: Baseline up to 1 year post enrolment
measure: Functional capacity
timeFrame: Baseline up to 1 year post enrolment
measure: The impact of COVID-19 pandemic on psychological functioning
timeFrame: Baseline up to 1 year post enrolment
measure: Process Evaluation
timeFrame: Through study completion, an average of 12 months
Other outcomes:
measure: Exploratory: Overall survival
timeFrame: 1 year post enrolment
measure: Exploratory: Adherence to the interventions/advice
timeFrame: Baseline up to 1 year post enrolment
Locations:
city: Southampton
country: United Kingdom
facility: University Hospital Southampton NHS FT
Study officials:
References:
citation: Grimmett C, Bates A, West M, Leggett S, Varkonyi-Sepp J, Campbell A, Davis J, Wootton S, Shaw C, Barlow R, Ashcroft J, Scott A, Moyes H, Hawkins L, Levett DZH, Williams F, Grocott MPW, Jack S. SafeFit Trial: virtual clinics to deliver a multimodal intervention to improve psychological and physical well-being in people with cancer. Protocol of a COVID-19 targeted non-randomised phase III trial. BMJ Open. 2021 Aug 26;11(8):e048175. doi: 10.1136/bmjopen-2020-048175.