title: A web-based intervention (RESTORE) to support self-management of cancer-related fatigue following primary cancer treatment: a multi-centre proof of concept randomised controlled trial.
abstract: Cancer-related fatigue (CRF) is a frequent and distressing symptom experienced after cancer treatment. RESTORE is the first web-based resource designed to enhance self-efficacy to manage CRF following curative-intent treatment. The aim of this study is to test the proof of concept and inform the design of an effectiveness trial.
  
  
  
  A multi-centre parallel-group two-armed (1:1) exploratory randomised controlled trial (RCT) with qualitative process evaluation was employed in the study. Participants (≥18 years; ≤5 years post treatment with moderate to severe fatigue) were recruited and randomly assigned to RESTORE or a leaflet. Feasibility and acceptability were measured by recruitment, attrition, intervention adherence, completion of outcome measures and process evaluation. Change in self-efficacy to manage CRF was also explored. Outcome measures were completed at baseline (T0), 6 weeks (T1) and 12 weeks (T2). Data were analysed using mixed-effects linear regression and directed content analysis.
  
  
  
  One hundred and sixty-three people participated in the trial and 19 in the process evaluation. The intervention was feasible (39 % of eligible patients consented) and acceptable (attrition rate 36 %). There was evidence of higher fatigue self-efficacy at T1 in the intervention group vs comparator (mean difference 0.51 [-0.08 to 1.11]), though the difference in groups decreased by 12 weeks. Time since diagnosis influenced perceived usefulness of the intervention. Modifications were suggested.
  
  
  
  Proof of concept was achieved. The RESTORE intervention should be subject to a definitive trial with some adjustments. Provision of an effective supportive resource would empower cancer survivors to manage CRF after treatment completion.
  
  
  
  ISRCTN67521059.
authors.affiliation: Macmillan Survivorship Research Group, Faculty of Health Sciences, University of Southampton, Highfield, Southampton, SO17 1BJ, UK. C.L.Foster@soton.ac.uk.
authors.forename: Claire
authors.initials: C
authors.lastname: Foster
authors.affiliation: Macmillan Survivorship Research Group, Faculty of Health Sciences, University of Southampton, Highfield, Southampton, SO17 1BJ, UK.
authors.forename: Chloe
authors.initials: C
authors.lastname: Grimmett
authors.affiliation: Macmillan Survivorship Research Group, Faculty of Health Sciences, University of Southampton, Highfield, Southampton, SO17 1BJ, UK.
authors.forename: Christine M
authors.initials: CM
authors.lastname: May
authors.affiliation: Southampton Statistical Research Institute, University of Southampton, Highfield, Southampton, SO17 1BJ, UK.
authors.forename: Sean
authors.initials: S
authors.lastname: Ewings
authors.affiliation: Macmillan Survivorship Research Group, Faculty of Health Sciences, University of Southampton, Highfield, Southampton, SO17 1BJ, UK.
authors.forename: Michelle
authors.initials: M
authors.lastname: Myall
authors.affiliation: Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, LS2 9LJ, UK.
authors.forename: Claire
authors.initials: C
authors.lastname: Hulme
authors.affiliation: Southampton Statistical Research Institute, University of Southampton, Highfield, Southampton, SO17 1BJ, UK.
authors.forename: Peter W
authors.initials: PW
authors.lastname: Smith
authors.affiliation: Macmillan Survivorship Research Group, Faculty of Health Sciences, University of Southampton, Highfield, Southampton, SO17 1BJ, UK.
authors.forename: Cassandra
authors.initials: C
authors.lastname: Powers
authors.affiliation: Macmillan Survivorship Research Group, Faculty of Health Sciences, University of Southampton, Highfield, Southampton, SO17 1BJ, UK.
authors.forename: Lynn
authors.initials: L
authors.lastname: Calman
authors.affiliation: Florence Nightingale School of Nursing & Midwifery, King's College, London, SE1 8WA, UK.
authors.forename: Jo
authors.initials: J
authors.lastname: Armes
authors.affiliation: Institute of Health & Society, Newcastle University, Newcastle upon Tyne, NE2 4AX, UK.
authors.forename: Matthew
authors.initials: M
authors.lastname: Breckons
authors.affiliation: Faculty of Health Sciences, University of Southampton, Highfield, Southampton, SO17 1BJ, UK.
authors.forename: Jessica
authors.initials: J
authors.lastname: Corner
authors.affiliation: Faculty of Health Sciences, University of Southampton, Highfield, Southampton, SO17 1BJ, UK.
authors.forename: Deborah
authors.initials: D
authors.lastname: Fenlon
authors.affiliation: Faculty of Health Sciences, University of Southampton, Highfield, Southampton, SO17 1BJ, UK.
authors.forename: Lynn
authors.initials: L
authors.lastname: Batehup
authors.affiliation: University Hospital Southampton NHS Foundation Trust, Southampton General Hospital, Southampton, SO16 6YD, UK.
authors.forename: Elaine
authors.initials: E
authors.lastname: Lennan
authors.affiliation: Faculty of Health Sciences, University of Southampton, Highfield, Southampton, SO17 1BJ, UK.
authors.forename: Carl
authors.initials: C
authors.lastname: R May
authors.affiliation: Research Partner, London, UK.
authors.forename: Carolyn
authors.initials: C
authors.lastname: Morris
authors.affiliation: Macmillan Cancer Support, London, SE1 7UQ, UK.
authors.forename: Amanda
authors.initials: A
authors.lastname: Neylon
authors.affiliation: Faculty of Health and Medical Sciences, University of Surrey, Guildford, Surrey, GU2 7JP, UK.
authors.forename: Emma
authors.initials: E
authors.lastname: Ream
authors.affiliation: Research Partner, London, UK.
authors.forename: Lesley
authors.initials: L
authors.lastname: Turner
authors.affiliation: Psychology, University of Southampton, Highfield, Southampton, SO17 1BJ, UK.
authors.forename: Lucy
authors.initials: L
authors.lastname: Yardley
authors.affiliation: Faculty of Health Sciences, University of Southampton, Highfield, Southampton, SO17 1BJ, UK.|University Hospital Southampton NHS Foundation Trust, Southampton General Hospital, Southampton, SO16 6YD, UK.
authors.forename: Alison
authors.initials: A
authors.lastname: Richardson
mesh_terms: D000328:Adult; D000368:Aged; D005221:Fatigue / Q000209:etiology / Q000628:therapy*; D005260:Female; D006801:Humans; D020407:Internet; D008297:Male; D008875:Middle Aged; D009369:Neoplasms / Q000150:complications / Q000628:therapy*; D010465:Perception; D012648:Self Care / Q000379:methods*; D020377:Self Efficacy; D017741:Survivors
keywords: Cancer; Fatigue; Intervention; Self-management; Web-based