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

Claire Foster; Chloe Grimmett; Christine M May; Sean Ewings; Michelle Myall; Claire Hulme; Peter W Smith; Cassandra Powers; Lynn Calman; Jo Armes; Matthew Breckons; Jessica Corner; Deborah Fenlon; Lynn Batehup; Elaine Lennan; Carl R May; Carolyn Morris; Amanda Neylon; Emma Ream; Lesley Turner; Lucy Yardley; Alison Richardson

doi:10.1007/s00520-015-3044-7

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

Claire Foster, Chloe Grimmett, Christine M May, Sean Ewings, Michelle Myall, Claire Hulme, Peter W Smith, Cassandra Powers, Lynn Calman, Jo Armes, Matthew Breckons, Jessica Corner, Deborah Fenlon, Lynn Batehup, Elaine Lennan, Carl R May, Carolyn Morris, Amanda Neylon, Emma Ream, Lesley TurnerLucy Yardley, Alison Richardson

Research output: Contribution to journal › Article (Academic Journal) › peer-review

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Abstract

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.

Original language	English
Pages (from-to)	2445-53
Number of pages	9
Journal	Supportive Care in Cancer
Volume	24
Issue number	6
Early online date	7 Dec 2015
DOIs	https://doi.org/10.1007/s00520-015-3044-7
Publication status	Published - Jun 2016

Structured keywords

Physical and Mental Health
Digital Health

Keywords

Adult
Aged
Fatigue/etiology
Female
Humans
Internet
Male
Middle Aged
Neoplasms/complications
Perception
Self Care/methods
Self Efficacy
Survivors

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1007/s00520-015-3044-7

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Foster, C., Grimmett, C., May, C. M., Ewings, S., Myall, M., Hulme, C., Smith, P. W., Powers, C., Calman, L., Armes, J., Breckons, M., Corner, J., Fenlon, D., Batehup, L., Lennan, E., R May, C., Morris, C., Neylon, A., Ream, E., ... Richardson, A. (2016). 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. Supportive Care in Cancer, 24(6), 2445-53. https://doi.org/10.1007/s00520-015-3044-7

@article{b19bb739fbd1405181fc57efd236dbee,

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 = "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.",

keywords = "Adult, Aged, Fatigue/etiology, Female, Humans, Internet, Male, Middle Aged, Neoplasms/complications, Perception, Self Care/methods, Self Efficacy, Survivors",

author = "Claire Foster and Chloe Grimmett and May, {Christine M} and Sean Ewings and Michelle Myall and Claire Hulme and Smith, {Peter W} and Cassandra Powers and Lynn Calman and Jo Armes and Matthew Breckons and Jessica Corner and Deborah Fenlon and Lynn Batehup and Elaine Lennan and {R May}, Carl and Carolyn Morris and Amanda Neylon and Emma Ream and Lesley Turner and Lucy Yardley and Alison Richardson",

year = "2016",

month = jun,

doi = "10.1007/s00520-015-3044-7",

language = "English",

volume = "24",

pages = "2445--53",

journal = "Supportive Care in Cancer",

issn = "0941-4355",

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Foster, C, Grimmett, C, May, CM, Ewings, S, Myall, M, Hulme, C, Smith, PW, Powers, C, Calman, L, Armes, J, Breckons, M, Corner, J, Fenlon, D, Batehup, L, Lennan, E, R May, C, Morris, C, Neylon, A, Ream, E, Turner, L, Yardley, L & Richardson, A 2016, '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', Supportive Care in Cancer, vol. 24, no. 6, pp. 2445-53. https://doi.org/10.1007/s00520-015-3044-7

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. / Foster, Claire; Grimmett, Chloe; May, Christine M et al.
In: Supportive Care in Cancer, Vol. 24, No. 6, 06.2016, p. 2445-53.

Research output: Contribution to journal › Article (Academic Journal) › peer-review

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 - 2016/6

Y1 - 2016/6

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 - Adult

KW - Aged

KW - Fatigue/etiology

KW - Female

KW - Humans

KW - Internet

KW - Male

KW - Middle Aged

KW - Neoplasms/complications

KW - Perception

KW - Self Care/methods

KW - Self Efficacy

KW - Survivors

U2 - 10.1007/s00520-015-3044-7

DO - 10.1007/s00520-015-3044-7

M3 - Article (Academic Journal)

C2 - 26643072

SN - 0941-4355

VL - 24

SP - 2445

EP - 2453

JO - Supportive Care in Cancer

JF - Supportive Care in Cancer

IS - 6

ER -

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

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Keywords

UN SDGs

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