TY - JOUR
T1 - Protocol for a phase III pragmatic stepped wedge cluster randomised controlled trial comparing the effectiveness and cost-effectiveness of screening and guidelines with, versus without, implementation strategies for improving pain in adults with cancer attending outpatient oncology and palliative care services
T2 - The Stop Cancer PAIN trial
AU - Luckett, Tim
AU - Phillips, Jane
AU - Agar, Meera
AU - Lam, Lawrence
AU - Davidson, Patricia M.
AU - McCaffrey, Nicola
AU - Boyle, Frances
AU - Shaw, Tim
AU - Currow, David C.
AU - Read, Alison
AU - Hosie, Annmarie
AU - Lovell, Melanie
N1 - Funding Information:
The authors wish to acknowledge Prof Ian Olver and Jutta von Dincklage for hosting the pain guidelines on the Cancer Council of Australia Cancer Guideline Wiki. We also acknowledge contributions to developing the implementation strategies to be evaluated in this trial by Natalie Marie, Mary-Rose Birch, Anna Green and Dr. Ben Forster. Dr. Ben Forster and author Prof Fran Boyle were supported by the Friends of the Mater Foundation. We acknowledge members of the trial’s Executive Committee responsible for overseeing the project, including: A/Prof Melanie Lovell (Chair), Prof Meera Agar, Dr. Tim Luckett and Prof Jane Phillips. We acknowledge project team members at the coordinating centre (University of Technology Sydney) responsible for recruiting participants and collecting and managing data, including: Annmarie Hosie, Tim Luckett, Alison Read (project managers), Molly Cao, Sally Fielding, Layla Hall, Renee Xu (research assistants), Seong Cheah, Kaniz Fatema (data managers). Finally, we acknowledge members of the Stop Cancer PAIN Advisory Group for their ongoing support and advice to the project, including: Prof Sanchia Aranda, Prof Phyllis Butow, Dr. Ben Forster, A/Prof Michael Izard, Ms. Niamh O’Neill, Dr. Nathan Taylor, Dr. Ian Thong, Ms. Noelene Trotter, Ms. Jutta von Dincklage and Prof Patsy Yates.
Funding Information:
The trial is funded by the Australian National Breast Cancer Foundation. Contact details are as follows: Level 9, 10 Barrack Street, Sydney, NSW 2000, Australia; T: + 61 2 8098 4800 F: + 61 2 8098 4801 E: info@nbcf.org.au The sponsor has had no role in the study design beyond requesting an over-sampling of patients with breast cancer, and has no role in: the collection, management, analysis, and interpretation of data; writing of the report; and the decision to submit the report for publication.
Funding Information:
There will be two patient participant populations for this study. The first will contribute to primary outcome data, and the second to secondary outcomes. Because the study is funded by the National Breast Cancer Foundation (NBCF) of Australia, sampling will aim to recruit ≥60% patients with breast cancer. It is anticipated that breast cancer’s prevalence and this population’s proven willingness to participate in clinical trials [31] will make over-sampling unnecessary.
Publisher Copyright:
© 2018 The Author(s).
PY - 2018/7/16
Y1 - 2018/7/16
N2 - Background: Pain is a common and distressing symptom in people with cancer, but is under-recognised and under-treated. Australian guidelines for 'Cancer Pain Management in Adults' are available on the Cancer Council Australia Cancer Guideline Wiki. This study aims to evaluate the effectiveness and cost-effectiveness of a suite of guideline implementation strategies for improving pain outcomes in adults with cancer in oncology and palliative care outpatient settings. Methods: The study will use a stepped-wedge cluster randomised controlled design, with oncology and palliative care outpatient services as the clusters. Patients will be eligible if they are adults with cancer and pain presenting to participating services during the study period. During an initial control arm, services will routinely screen patients for average and worst pain over the past 24 h using a 0-10 numerical rating scale (NRS) and have unfettered access to online guidelines. During the intervention arm, staff at each service will be encouraged to use: 1) a patient education booklet and self-management resource; 2) an online spaced learning cancer pain education module for clinicians from different disciplines; and 3) audit and feedback of service performance on key indices of cancer pain screening, assessment and management. Service-based clinical change champions will lead implementation of these strategies. The trial's primary outcome will be the probability that patients initially screened as having moderate-severe (≥5/10 NRS) worst pain experience a clinically important improvement one week later, defined as ≥ 30% reduction. Secondary outcomes will include patient empowerment and quality of life, carer experience, and cost-effectiveness. For the main analysis, linear mixed models will be used, accounting for clustering and the longitudinal design. Eighty-two patients per service at six services (N = 492) will provide > 90% power. A qualitative sub-study and analyses of structural and process factors will explore opportunities for further refinement and tailoring of the intervention. Discussion: This pragmatic trial will inform implementation of guidelines across a range of oncology and palliative care outpatient service contexts. If found effective, the implementation strategies will be made freely available on the Wiki alongside the guidelines. Trial registration: Registered 23/01/2015 on the Australian New Zealand Clinical Trials Registry (ACTRN12615000064505).
AB - Background: Pain is a common and distressing symptom in people with cancer, but is under-recognised and under-treated. Australian guidelines for 'Cancer Pain Management in Adults' are available on the Cancer Council Australia Cancer Guideline Wiki. This study aims to evaluate the effectiveness and cost-effectiveness of a suite of guideline implementation strategies for improving pain outcomes in adults with cancer in oncology and palliative care outpatient settings. Methods: The study will use a stepped-wedge cluster randomised controlled design, with oncology and palliative care outpatient services as the clusters. Patients will be eligible if they are adults with cancer and pain presenting to participating services during the study period. During an initial control arm, services will routinely screen patients for average and worst pain over the past 24 h using a 0-10 numerical rating scale (NRS) and have unfettered access to online guidelines. During the intervention arm, staff at each service will be encouraged to use: 1) a patient education booklet and self-management resource; 2) an online spaced learning cancer pain education module for clinicians from different disciplines; and 3) audit and feedback of service performance on key indices of cancer pain screening, assessment and management. Service-based clinical change champions will lead implementation of these strategies. The trial's primary outcome will be the probability that patients initially screened as having moderate-severe (≥5/10 NRS) worst pain experience a clinically important improvement one week later, defined as ≥ 30% reduction. Secondary outcomes will include patient empowerment and quality of life, carer experience, and cost-effectiveness. For the main analysis, linear mixed models will be used, accounting for clustering and the longitudinal design. Eighty-two patients per service at six services (N = 492) will provide > 90% power. A qualitative sub-study and analyses of structural and process factors will explore opportunities for further refinement and tailoring of the intervention. Discussion: This pragmatic trial will inform implementation of guidelines across a range of oncology and palliative care outpatient service contexts. If found effective, the implementation strategies will be made freely available on the Wiki alongside the guidelines. Trial registration: Registered 23/01/2015 on the Australian New Zealand Clinical Trials Registry (ACTRN12615000064505).
KW - Audit and feedback
KW - Cancer
KW - Clinical change champions
KW - Guidelines
KW - Health professional education
KW - Implementation
KW - Pain
KW - Patient education
KW - Self-management
KW - Translation
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U2 - 10.1186/s12913-018-3318-0
DO - 10.1186/s12913-018-3318-0
M3 - Article
C2 - 30012122
AN - SCOPUS:85050165929
SN - 1472-6963
VL - 18
JO - BMC health services research
JF - BMC health services research
IS - 1
M1 - 558
ER -