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

TY - JOUR

T1 - A web-based intervention (RESTORE) to support self-management of cancer-related fatigue following primary cancer treatment

T2 - a multi-centre proof of concept randomised controlled trial

AU - Foster, Claire

AU - Grimmett, Chloe

AU - May, Christine M.

AU - Ewings, Sean

AU - Myall, Michelle

AU - Hulme, Claire

AU - Smith, Peter W.

AU - Powers, Cassandra

AU - Calman, Lynn

AU - Armes, Jo

AU - Breckons, Matthew

AU - Corner, Jessica

AU - Fenlon, Deborah

AU - Batehup, Lynn

AU - Lennan, Elaine

AU - R. May, Carl

AU - Morris, Carolyn

AU - Neylon, Amanda

AU - Ream, Emma

AU - Turner, Lesley

AU - Yardley, Lucy

AU - Richardson, Alison

PY - 2015/12/7

Y1 - 2015/12/7

N2 - Purpose: 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. Methods: 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. Results: 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. Conclusion: 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. Trial registration: ISRCTN67521059

AB - Purpose: 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. Methods: 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. Results: 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. Conclusion: 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. Trial registration: ISRCTN67521059

KW - Cancer

KW - Fatigue

KW - Intervention

KW - Self-management

KW - Web-based

UR - http://www.scopus.com/inward/record.url?scp=84949524345&partnerID=8YFLogxK

U2 - 10.1007/s00520-015-3044-7

DO - 10.1007/s00520-015-3044-7

M3 - Article

AN - SCOPUS:84949524345

SN - 0941-4355

SP - 1

EP - 9

JO - Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer

JF - Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer

ER -