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

PurposeCancer-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.MethodsA 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.ResultsOne 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.ConclusionProof 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.Trial registrationISRCTN67521059

Effectiveness of e‐health based self‐management to improve cancer‐related fatigue, self‐efficacy and quality of life in cancer patients: Systematic review and meta‐analysis

“…The trials were published between 2005–2018. Trials were undertaken in the USA (Bantum et al, ; Owen et al, ; Smith et al, ; Somers et al, ; Syrjala et al, ), Netherlands (Admiraal et al, ; van der Berg et al, ; Boele et al, ; Golsteijn et al, ; Willems et al, ), UK (Foster et al, ), Canada (Vallerand et al, ), China (Zhang et al, ; Zhu et al, ), and South Korea (Lee et al, ).…”

“…Participants in four trials were patients with any cancer (Foster et al, ; Bantum et al, ; Somers et al, ; Willems et al, ). The other eleven trials focused on specific cancers: breast cancer (Admiraal et al, ; van den Berg et al, ; Lee et al, ; Owen et al, ; Smith et al, ; Zhu et al, ), glioma (Boele et al, ), haematological cancer (Syrjala et al, ; Vallerand et al, ), rectal cancer (Zhang et al, ), and both colorectal cancer and prostate cancer (Golsteijn et al, ).…”

“…The other eleven trials focused on specific cancers: breast cancer (Admiraal et al, ; van den Berg et al, ; Lee et al, ; Owen et al, ; Smith et al, ; Zhu et al, ), glioma (Boele et al, ), haematological cancer (Syrjala et al, ; Vallerand et al, ), rectal cancer (Zhang et al, ), and both colorectal cancer and prostate cancer (Golsteijn et al, ). Nine trials reported participants who completed primary treatment (Admiraal et al, ; van der Berg et al, ; Foster et al, ; Lee et al, ; Bantum et al, ; Somers et al, ; Syrjala et al, ; Willems et al, ; Zhang et al, ); the time since treatment completion was 4 weeks to 18 years. One trial included participants undergoing treatment (Zhu et al, ), while another one included both undergoing treatment and primary treatment completed (Golsteijn et al, ).…”

The efficacy of Internet‐based cognitive behavioral therapy for severely fatigued survivors of breast cancer compared with care as usual: A randomized controlled trial

“…5 In addition, explorative analyses of a feasibility RCT by Foster et al 6 demonstrated that a Web-based self-management intervention enhanced the self-efficacy of cancer survivors in managing fatigue compared with a patients with a control condition who only received an information leaflet. However, the effects of other types of Web-based interventions aimed at fatigue in cancer survivors are promising.…”

e-TC: Development and pilot testing of a web-based intervention to reduce anxiety and depression in survivors of testicular cancer

“…David, Schlenker, Prudlo, & Larbig, 2013;Wootten et al, 2015), indicating a need for further development and evaluation. Online interventions for people affected by cancer vary widely, with some focused on cancer survivors generally (Beatty, Kemp, Wade, & Koczwara, 2015;Willems et al, 2015), some focused on a specific issue such as fatigue (Foster et al, 2016) and others focused on people affected by a particular type of cancer, such as breast (Fergus et al, 2014) or prostate cancer (Wootten et al, 2015). Online interventions for people affected by cancer vary widely, with some focused on cancer survivors generally (Beatty, Kemp, Wade, & Koczwara, 2015;Willems et al, 2015), some focused on a specific issue such as fatigue (Foster et al, 2016) and others focused on people affected by a particular type of cancer, such as breast (Fergus et al, 2014) or prostate cancer (Wootten et al, 2015).…”