SafeFit Trial: Virtual clinics to deliver universal interventions [COVID-19]

  • Research type

    Research Study

  • Full title

    SafeFit Trial: Virtual clinics to deliver universal interventions (nutrition, exercise and psychological support) to maintain and improve physical health and psychological wellbeing in people with cancer who are following social distancing guidance: A COVID-19 targeted trial

  • IRAS ID

    282896

  • Contact name

    Sandy Jack

  • Contact email

    s.jack@soton.ac.uk

  • Clinicaltrials.gov Identifier

    NCT04425616

  • Duration of Study in the UK

    2 years, 3 months, 0 days

  • Research summary

    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”\n\nThe 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. \n\nThe effects of this pandemic has reportedly led to increased anxiety and distress and risks deconditioning. 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.\n\nThe 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. \n\nThe intervention will be delivered remotely for a duration of 6 months using one or more of the following: individual telephone consultations, one to one video sessions and/or group sessions, signposting to relevant nutritional information and online platforms to address their needs, and videos/live forum offered through social media platforms to address psychological needs?. Those delivering the intervention will be trained and supported by a team of experts in cancer prehabilitation. \n

  • REC name

    North West - Liverpool Central Research Ethics Committee

  • REC reference

    20/NW/0254

  • Date of REC Opinion

    20 May 2020

  • REC opinion

    Further Information Favourable Opinion