SafeFit Trial: Virtual Clinics to Deliver Universal Interventions in People With Cancer

U

University Hospital Southampton NHS Foundation Trust

Status

Active, not recruiting

Conditions

COVID
Cancer

Treatments

Other: Nutrition
Other: Exercise
Behavioral: Psychological and Behaviour Change Support

Study type

Interventional

Funder types

Other

Identifiers

NCT04425616
RHM CRI 0403

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,100 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

1,100 participants in 1 patient group

Universal Interventions
Experimental group
Description:
The delivery of nutrition, exercise and psychological interventions delivered in the following structure: Month 1: Up to three times per week Months 2-3: Once per week Months 4 - 6: One session per month for the last 3 months
Treatment:
Behavioral: Psychological and Behaviour Change Support
Other: Exercise
Other: Nutrition

Trial contacts and locations

1

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Central trial contact

Samantha Leggett, BSc; Sandy Jack, pHD

Data sourced from clinicaltrials.gov

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