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

Abstract

IntroductionThe impact of the COVID-19 pandemic (caused by the SARS-CoV-2 virus) on individuals with cancer has been profound. It has led to increased anxiety, distress and deconditioning due to reduced physical activity. We aim to investigate whether SafeFit, a multimodal intervention of physical activity, nutrition and psychological support delivered virtually by cancer exercise specialists (CES), can improve physical and emotional functionings during the COVID-19 pandemic.Methods and analysisA phase III non-randomised intervention trial, target recruitment of 1050 adults with suspected or confirmed diagnosis of cancer. All recruited participants will receive the multimodal intervention delivered by CES for 6 months. Sessions will be delivered 1-to-1 using telephone/video conferencing consultations. CES will work with each participant to devise a personalised programme of (1) physical activity, (2) basic dietary advice and (3) psychological support, all underpinned by behaviour change support.Primary outcomePhysical and emotional functioning as measured by the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC-QLQ-C30). Secondary outcomes: overall quality of life measured by EORTC-QLQ-C30 and EQ-5D-5L, health economics, patient activation, self-efficacy to self-manage chronic disease, distress, impact of COVID-19 on emotional functioning, self-reported physical activity, functional capacity and nutrition. Adherence to the intervention will also be measured and a process evaluation conducted.Ethics and disseminationEthical approval was obtained from the Health Research Authority (reference number 20/NW/0254). Results of this trial will be disseminated through publication of peer-reviewed articles, presentations at scientific conferences, and to the public and people with cancer in collaboration with our patient and public involvement representatives and partners.Trial registration numberNCT04425616.

Frail2Fit study protocol: a feasibility and acceptability study of a virtual multimodal intervention delivered by volunteers to improve functional outcomes in older adults with frailty after discharge from hospital

“…Volunteers will receive a bespoke training package adapted from the SafeFit trial. 23 Exercise and nutrition training will be delivered by the research team in-person, and behaviour change support training will be delivered online. Once the three training components have been completed, a member of the research team will shadow the volunteers during the first month of intervention delivery.…”

“…Group sessions will last 40–60 min. The components of the intervention and the training package have been adapted from the SafeFit, SoMoVe and ImPACt studies 18 23 40…”

“…Moreover, online communication tools have gained popularity among older people to remain socially connected, allowing PA and nutrition interventions to be delivered online 22. Our research (the SafeFit trial) showed that exercise professionals could be trained to deliver an online intervention to maintain and improve physical, nutritional and psychological well-being in people with cancer 23. Telephone conversations, tele-monitoring devices and internet-enabled tablets have also been shown as an effective means to deliver nutrition and PA interventions to community-dwelling older adults who were inactive or had malnutrition 24 25.…”

“… 22 Our research (the SafeFit trial) showed that exercise professionals could be trained to deliver an online intervention to maintain and improve physical, nutritional and psychological well-being in people with cancer. 23 Telephone conversations, tele-monitoring devices and internet-enabled tablets have also been shown as an effective means to deliver nutrition and PA interventions to community-dwelling older adults who were inactive or had malnutrition. 24 25 Nevertheless, there is little evidence on the use of trained volunteers to lead such interventions.…”

Brief psychological intervention to reduce psychological distress among preoperative cancer patients: A randomized, single-blind, two arm, parallel group controlled trial in a selected tertiary care hospital in Sri Lanka

“…Prehabilitation has been identi ed as a promising point for interventions to improve treatment outcomes and prevent long-term psychological morbidity among cancer patients (Silver and Baima, 2013). The type of psychological intervention has been broadly categorised into three as cognitive behavioural therapy, unimodal psychological prehabilitation, and multimodal psychological prehabilitation (Grimmett et al, 2021;Hamilton and Kroska, 2019). The simplicity and ease of administration of the present study's multimodal psychological prehabilitation is advantageous over most of these studies.…”