Investigation of an integrated standardised pain assessment and management tool in addition to usual care versus usual care alone in oncology outpatient clinics for adults with pain: the CAPTURE cluster randomised pilot trial protocol. ISRCRN86926298

Olivia C. Robinson; Elaine G. Boland; Florence Day; Marie Fallon; Amanda Farrin; Kate Flemming; Sean Girvan; Sue M. Hartup; Adam Hurlow; David Meads; Catriona R. Mayland; John L. O’Dwyer; Simon Pini; Suzanne H. Richards; Daniel Swinson; Michelle Collinson; Matthew R. Mulvey

doi:10.1186/s40814-025-01714-5

Investigation of an integrated standardised pain assessment and management tool in addition to usual care versus usual care alone in oncology outpatient clinics for adults with pain: the CAPTURE cluster randomised pilot trial protocol. ISRCRN86926298

Olivia C. Robinson, Elaine G. Boland, Florence Day, Marie Fallon, Amanda Farrin, Kate Flemming, Sean Girvan, Sue M. Hartup, Adam Hurlow, David Meads, Catriona R. Mayland, John L. O’Dwyer, Simon Pini, Suzanne H. Richards, Daniel Swinson, Michelle Collinson, Matthew R. Mulvey^*

^*Corresponding author for this work

Research output: Contribution to journal › Article › peer-review

Abstract

Background

Each year in the UK approximately 367,000 people are diagnosed with cancer of whom half will experience moderate to severe chronic pain and a third are undertreated for their pain. Most people with cancer are cared for at oncology outpatient services where there are no standardised approaches for managing pain. As a result, cancer patients are at risk of receiving inadequate care for pain. There is a need for a standardised approach to pain management within oncology outpatient services.
Methods/design

The aim of this pilot trial is to establish the feasibility of conducting a multi-centre clustered-randomised trial of an integrated standardised pain assessment and management programme integrated within routine care at oncology outpatient services in the United Kingdom National Health Service (NHS).

We will conduct a two-arm pilot cluster randomised trial with nested process evaluation to evaluate the feasibility and acceptability of trial processes, establish fidelity of intervention implementation, estimate variability in outcomes and feasibility of future economic evaluation. Twelve outpatient services (clusters) from at least two NHS tertiary oncology referral centres (sites), in the North of England will be randomised (1:1) to deliver a pain management programme plus usual care or usual care alone and will recruit a total sample of 180 participants. Adults attending a participating outpatient service who self-report a score of ≥ 3 on the 0–10 Numerical Rating Scale (NRS) for worst pain in the past 72 h in any part of their body, and will be available for 1-week follow-up will be eligible. Participant self-reported questionnaires will be collected at baseline, 1-week, 1-month, and 2-months with medical record review at 1-month and 2-months. Progression to a future trial will be based on pre-defined criteria associated with eligibility and consent rates, follow-up and intervention delivery and acceptability.
Discussion

Little research has described optimal ways to implement a standardised pain assessment and management programme into oncology outpatient services. The strengths of the pilot trial are its sample size, number of clusters, and planned evaluation of trial processes and intervention fidelity to provide robust trial evidence to fully inform a future definitive phase III multi-centre cluster randomised trial within the UK NHS.
Trial registration

The CAPTURE pilot trial is registered on the ISRCTN registry (86,926,298).

Original language	English
Journal	Pilot and Feasibility Studies
Volume	11
Issue number	1
DOIs	https://doi.org/10.1186/s40814-025-01714-5 https://doi.org/10.1186/s40814-025-01714-5
Publication status	Published - 30 Oct 2025

Keywords / Materials (for Non-textual outputs)

cancer
pain
cluster trial
pilot
outpatient setting

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s40814-025-01714-5-1
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Robinson, O. C., Boland, E. G., Day, F., Fallon, M., Farrin, A., Flemming, K., Girvan, S., Hartup, S. M., Hurlow, A., Meads, D., Mayland, C. R., O’Dwyer, J. L., Pini, S., Richards, S. H., Swinson, D., Collinson, M., & Mulvey, M. R. (2025). Investigation of an integrated standardised pain assessment and management tool in addition to usual care versus usual care alone in oncology outpatient clinics for adults with pain: the CAPTURE cluster randomised pilot trial protocol. ISRCRN86926298. Pilot and Feasibility Studies, 11(1). https://doi.org/10.1186/s40814-025-01714-5, https://doi.org/10.1186/s40814-025-01714-5

Robinson, Olivia C. ; Boland, Elaine G. ; Day, Florence et al. / Investigation of an integrated standardised pain assessment and management tool in addition to usual care versus usual care alone in oncology outpatient clinics for adults with pain: the CAPTURE cluster randomised pilot trial protocol. ISRCRN86926298. In: Pilot and Feasibility Studies. 2025 ; Vol. 11, No. 1.

@article{6c069c4dd64c4757ae9aab9bc5173316,

title = "Investigation of an integrated standardised pain assessment and management tool in addition to usual care versus usual care alone in oncology outpatient clinics for adults with pain: the CAPTURE cluster randomised pilot trial protocol. ISRCRN86926298",

abstract = "Background Each year in the UK approximately 367,000 people are diagnosed with cancer of whom half will experience moderate to severe chronic pain and a third are undertreated for their pain. Most people with cancer are cared for at oncology outpatient services where there are no standardised approaches for managing pain. As a result, cancer patients are at risk of receiving inadequate care for pain. There is a need for a standardised approach to pain management within oncology outpatient services. Methods/design The aim of this pilot trial is to establish the feasibility of conducting a multi-centre clustered-randomised trial of an integrated standardised pain assessment and management programme integrated within routine care at oncology outpatient services in the United Kingdom National Health Service (NHS). We will conduct a two-arm pilot cluster randomised trial with nested process evaluation to evaluate the feasibility and acceptability of trial processes, establish fidelity of intervention implementation, estimate variability in outcomes and feasibility of future economic evaluation. Twelve outpatient services (clusters) from at least two NHS tertiary oncology referral centres (sites), in the North of England will be randomised (1:1) to deliver a pain management programme plus usual care or usual care alone and will recruit a total sample of 180 participants. Adults attending a participating outpatient service who self-report a score of ≥ 3 on the 0–10 Numerical Rating Scale (NRS) for worst pain in the past 72 h in any part of their body, and will be available for 1-week follow-up will be eligible. Participant self-reported questionnaires will be collected at baseline, 1-week, 1-month, and 2-months with medical record review at 1-month and 2-months. Progression to a future trial will be based on pre-defined criteria associated with eligibility and consent rates, follow-up and intervention delivery and acceptability. Discussion Little research has described optimal ways to implement a standardised pain assessment and management programme into oncology outpatient services. The strengths of the pilot trial are its sample size, number of clusters, and planned evaluation of trial processes and intervention fidelity to provide robust trial evidence to fully inform a future definitive phase III multi-centre cluster randomised trial within the UK NHS. Trial registration The CAPTURE pilot trial is registered on the ISRCTN registry (86,926,298).",

keywords = "cancer, pain, cluster trial, pilot, outpatient setting",

author = "Robinson, \{Olivia C.\} and Boland, \{Elaine G.\} and Florence Day and Marie Fallon and Amanda Farrin and Kate Flemming and Sean Girvan and Hartup, \{Sue M.\} and Adam Hurlow and David Meads and Mayland, \{Catriona R.\} and O{\textquoteright}Dwyer, \{John L.\} and Simon Pini and Richards, \{Suzanne H.\} and Daniel Swinson and Michelle Collinson and Mulvey, \{Matthew R.\}",

note = "MRM is the chief investigator for this study; he conceived the project, led the design and writing of the trial protocol and drafting of this manuscript. OR led the writing of the trial protocol and wrote the first draft of this manuscript. OCR, MC, FD, SR, MRM, DM, SG, JOD designed the study and wrote the original protocol. OCR and MRM led the embedded process evaluation. OR is the process evaluation researcher. MC, SR, SG, and MRM developed the statistical analysis plan. DM and JOD led the health economic evaluation and developed the analysis plan. MC co-conceived and designed the trial, wrote the trial protocol and supervises all statistical aspects of the trial. MC is joint last author with MRM. FD coordinated operational delivery of the trial in CTRU. SG provided statistical input, under the supervision of MC. All authors contributed to manuscript revision, read, and approved the submitted version.",

year = "2025",

month = oct,

day = "30",

doi = "10.1186/s40814-025-01714-5",

language = "English",

volume = "11",

journal = "Pilot and Feasibility Studies",

issn = "2055-5784",

publisher = "BioMed Central",

number = "1",

}

Robinson, OC, Boland, EG, Day, F, Fallon, M , Farrin, A, Flemming, K, Girvan, S, Hartup, SM, Hurlow, A, Meads, D, Mayland, CR, O’Dwyer, JL, Pini, S, Richards, SH, Swinson, D, Collinson, M & Mulvey, MR 2025, 'Investigation of an integrated standardised pain assessment and management tool in addition to usual care versus usual care alone in oncology outpatient clinics for adults with pain: the CAPTURE cluster randomised pilot trial protocol. ISRCRN86926298', Pilot and Feasibility Studies, vol. 11, no. 1. https://doi.org/10.1186/s40814-025-01714-5, https://doi.org/10.1186/s40814-025-01714-5

Investigation of an integrated standardised pain assessment and management tool in addition to usual care versus usual care alone in oncology outpatient clinics for adults with pain: the CAPTURE cluster randomised pilot trial protocol. ISRCRN86926298. / Robinson, Olivia C.; Boland, Elaine G.; Day, Florence et al.
In: Pilot and Feasibility Studies, Vol. 11, No. 1, 30.10.2025.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - Investigation of an integrated standardised pain assessment and management tool in addition to usual care versus usual care alone in oncology outpatient clinics for adults with pain: the CAPTURE cluster randomised pilot trial protocol. ISRCRN86926298

AU - Robinson, Olivia C.

AU - Boland, Elaine G.

AU - Day, Florence

AU - Fallon, Marie

AU - Farrin, Amanda

AU - Flemming, Kate

AU - Girvan, Sean

AU - Hartup, Sue M.

AU - Hurlow, Adam

AU - Meads, David

AU - Mayland, Catriona R.

AU - O’Dwyer, John L.

AU - Pini, Simon

AU - Richards, Suzanne H.

AU - Swinson, Daniel

AU - Collinson, Michelle

AU - Mulvey, Matthew R.

N1 - MRM is the chief investigator for this study; he conceived the project, led the design and writing of the trial protocol and drafting of this manuscript. OR led the writing of the trial protocol and wrote the first draft of this manuscript. OCR, MC, FD, SR, MRM, DM, SG, JOD designed the study and wrote the original protocol. OCR and MRM led the embedded process evaluation. OR is the process evaluation researcher. MC, SR, SG, and MRM developed the statistical analysis plan. DM and JOD led the health economic evaluation and developed the analysis plan. MC co-conceived and designed the trial, wrote the trial protocol and supervises all statistical aspects of the trial. MC is joint last author with MRM. FD coordinated operational delivery of the trial in CTRU. SG provided statistical input, under the supervision of MC. All authors contributed to manuscript revision, read, and approved the submitted version.

PY - 2025/10/30

Y1 - 2025/10/30

N2 - Background Each year in the UK approximately 367,000 people are diagnosed with cancer of whom half will experience moderate to severe chronic pain and a third are undertreated for their pain. Most people with cancer are cared for at oncology outpatient services where there are no standardised approaches for managing pain. As a result, cancer patients are at risk of receiving inadequate care for pain. There is a need for a standardised approach to pain management within oncology outpatient services. Methods/design The aim of this pilot trial is to establish the feasibility of conducting a multi-centre clustered-randomised trial of an integrated standardised pain assessment and management programme integrated within routine care at oncology outpatient services in the United Kingdom National Health Service (NHS). We will conduct a two-arm pilot cluster randomised trial with nested process evaluation to evaluate the feasibility and acceptability of trial processes, establish fidelity of intervention implementation, estimate variability in outcomes and feasibility of future economic evaluation. Twelve outpatient services (clusters) from at least two NHS tertiary oncology referral centres (sites), in the North of England will be randomised (1:1) to deliver a pain management programme plus usual care or usual care alone and will recruit a total sample of 180 participants. Adults attending a participating outpatient service who self-report a score of ≥ 3 on the 0–10 Numerical Rating Scale (NRS) for worst pain in the past 72 h in any part of their body, and will be available for 1-week follow-up will be eligible. Participant self-reported questionnaires will be collected at baseline, 1-week, 1-month, and 2-months with medical record review at 1-month and 2-months. Progression to a future trial will be based on pre-defined criteria associated with eligibility and consent rates, follow-up and intervention delivery and acceptability. Discussion Little research has described optimal ways to implement a standardised pain assessment and management programme into oncology outpatient services. The strengths of the pilot trial are its sample size, number of clusters, and planned evaluation of trial processes and intervention fidelity to provide robust trial evidence to fully inform a future definitive phase III multi-centre cluster randomised trial within the UK NHS. Trial registration The CAPTURE pilot trial is registered on the ISRCTN registry (86,926,298).

AB - Background Each year in the UK approximately 367,000 people are diagnosed with cancer of whom half will experience moderate to severe chronic pain and a third are undertreated for their pain. Most people with cancer are cared for at oncology outpatient services where there are no standardised approaches for managing pain. As a result, cancer patients are at risk of receiving inadequate care for pain. There is a need for a standardised approach to pain management within oncology outpatient services. Methods/design The aim of this pilot trial is to establish the feasibility of conducting a multi-centre clustered-randomised trial of an integrated standardised pain assessment and management programme integrated within routine care at oncology outpatient services in the United Kingdom National Health Service (NHS). We will conduct a two-arm pilot cluster randomised trial with nested process evaluation to evaluate the feasibility and acceptability of trial processes, establish fidelity of intervention implementation, estimate variability in outcomes and feasibility of future economic evaluation. Twelve outpatient services (clusters) from at least two NHS tertiary oncology referral centres (sites), in the North of England will be randomised (1:1) to deliver a pain management programme plus usual care or usual care alone and will recruit a total sample of 180 participants. Adults attending a participating outpatient service who self-report a score of ≥ 3 on the 0–10 Numerical Rating Scale (NRS) for worst pain in the past 72 h in any part of their body, and will be available for 1-week follow-up will be eligible. Participant self-reported questionnaires will be collected at baseline, 1-week, 1-month, and 2-months with medical record review at 1-month and 2-months. Progression to a future trial will be based on pre-defined criteria associated with eligibility and consent rates, follow-up and intervention delivery and acceptability. Discussion Little research has described optimal ways to implement a standardised pain assessment and management programme into oncology outpatient services. The strengths of the pilot trial are its sample size, number of clusters, and planned evaluation of trial processes and intervention fidelity to provide robust trial evidence to fully inform a future definitive phase III multi-centre cluster randomised trial within the UK NHS. Trial registration The CAPTURE pilot trial is registered on the ISRCTN registry (86,926,298).

KW - cancer

KW - pain

KW - cluster trial

KW - pilot

KW - outpatient setting

U2 - 10.1186/s40814-025-01714-5

DO - 10.1186/s40814-025-01714-5

M3 - Article

SN - 2055-5784

VL - 11

JO - Pilot and Feasibility Studies

JF - Pilot and Feasibility Studies

IS - 1

ER -

Robinson OC, Boland EG, Day F, Fallon M , Farrin A, Flemming K et al. Investigation of an integrated standardised pain assessment and management tool in addition to usual care versus usual care alone in oncology outpatient clinics for adults with pain: the CAPTURE cluster randomised pilot trial protocol. ISRCRN86926298. Pilot and Feasibility Studies. 2025 Oct 30;11(1). doi: 10.1186/s40814-025-01714-5, 10.1186/s40814-025-01714-5