Evidence map›Paper›PMID 34446487›Full record

ArticleBMJ open2021

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.

Chloe Grimmett, Andrew Bates, Malcolm West, Samantha Leggett, Judit Varkonyi-Sepp, Anna Campbell, June Davis, Stephen Wootton, Clare Shaw, Rachael Barlow and 8 more

3 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
1.6field-weighted citation impact, top 13% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04425616 nacompletednot on this map

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

TypeinterventionalSponsorUniversity Hospital Southampton NHS Foundation TrustRan2020 to 2024Enrolled1,100ConditionsCancer, COVIDArmsExercise, Psychological and Behaviour Change Support, Nutrition
NCT05384730 nacompletednot on this mapstarted 2022, after this paper: background citation

A Feasibility and Acceptability Study of a Virtual Multimodal Intervention Delivered by Volunteers to Improve Functional Outcomes of Frail Older Adults Discharged From Hospital

TypeinterventionalSponsorUniversity Hospital Southampton NHS Foundation TrustRan2022 to 2024Enrolled32ConditionsFrailty, Malnutrition, Sedentary BehaviorArmsGroup nutrition and exercise support
NCT06159803 unknown statusnot on this mapstarted 2024, after this paper: background citation

LIving BEtteR With asThma - Intervention Development Study

TypeobservationalSponsorUniversity Hospital Southampton NHS Foundation TrustRan2024 to 2025Enrolled50ConditionsAsthmaArmsQualitative Interview
3 · Its place in the literature

Who cites it

11 citing papers in PubMed, 27 citations in OpenAlex.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 9 institutions in 1 country.

Chloe GrimmettSchool of Health Sciences, University of Southampton, Southampton, UK C.Grimmett@soton.ac.uk.ORCID 0000-0002-7540-7206
Andrew BatesNIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Malcolm WestNIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Samantha LeggettNIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Judit Varkonyi-SeppNIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Anna CampbellSchool of Applied Science, Edinburgh Napier University, Edinburgh, UK.
June DavisMacmillan Cancer Support, London, UK.
Stephen WoottonSchool of Human Development and Health, Faculty of Medicine, University of Southampton, Southampton, UK.
Clare ShawNIHR Biomedical Research Centre, Royal Marsden NHS Foundation Trust, London, UK.
Rachael BarlowCardiff and Vale University Health Board, University Hospital of Wales, Cardiff, UK.
Joanna AshcroftSt George's University Hospitals NHS Foundation Trust, London, UK.
Andrew ScottSchool of Sport, Health and Exercise Science, University of Portsmouth, Portsmouth, UK.ORCID 0000-0003-1478-8962
Helen MoyesNIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Lesley HawkinsCritical Care/Anaesthesia and Perioperative Medicine Research Unit, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Denny Z H LevettNIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Fran WilliamsWessex Cancer Alliance, Southampton, UK.
Michael P W GrocottNIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
Sandy JackNIHR Southampton Biomedical Research Centre, University Hospital Southampton NHS Foundation Trust, Southampton, UK.
University Hospital Southampton NHS Foundation Trust · GBCardiff and Vale University Health Board · GBEdinburgh Napier University · GBMacmillan Cancer Support · GBNIHR CRUK Experimental Cancer Medicine Centre · GBRoyal Marsden NHS Foundation Trust · GBSt George’s University Hospitals NHS Foundation Trust · GBUniversity of Portsmouth · GBUniversity of Southampton · GB

Funding

Department of Health NIHR300405
6 · The paper itself

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 ANALYSIS: A 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 OUTCOME: Physical 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 DISSEMINATION: Ethical 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 NUMBER: NCT04425616.

Indexed as

COVID-19NeoplasmsAdultClinical Trials as TopicHumansPandemicsQuality of LifeSARS-CoV-2adult oncologyoncologypublic healthrehabilitation medicine

Identifiers

PMID34446487
PMCPMC8392740
OpenAlexW3194211469

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.