Overcoming recruitment challenges in palliative care clinical trials

LeBlanc, TW; Lodato, JE; Currow, DC; Abernethy, AP

Overcoming recruitment challenges in palliative care clinical trials

LeBlanc, TW Lodato, JE Currow, DC

Abernethy, AP

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Publication Type:: Journal Article
Citation:: Journal of Oncology Practice, 2013, 9 (6), pp. 277 - 282
Issue Date:: 2013-01-01

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Field	Value	Language
dc.contributor.author	LeBlanc, TW	en_US
dc.contributor.author	Lodato, JE	en_US
dc.contributor.author	Currow, DC https://orcid.org/0000-0003-1988-1250	en_US
dc.contributor.author	Abernethy, AP	en_US
dc.date.issued	2013-01-01	en_US
dc.identifier.citation	Journal of Oncology Practice, 2013, 9 (6), pp. 277 - 282	en_US
dc.identifier.issn	1554-7477	en_US
dc.identifier.uri	http://hdl.handle.net/10453/117421
dc.description.abstract	Purpose: Palliative care is increasingly viewed as a necessary component of cancer care, especially for patients with advanced disease. Rigorous clinical trials are thus needed to build the palliative care evidence base, but clinical research - especially participant recruitment - is difficult. Major barriers include (1) patient factors, (2) "gatekeeping," and (3) ethical concerns. Here we discuss an approach to overcoming these barriers, using the Palliative Care Trial (PCT) as a case study. Patients and Methods: The PCT was a 2 x 2 x 2 factorial randomized controlled trial (RCT) of different service delivery models to improve pain control in the palliative setting. It used a recruitment protocol that fused evidence-based strategies with principles of "social marketing," an approach involving the systematic application of marketing techniques. Main components included (1) an inclusive triage algorithm, (2) information booklets targeting particular stakeholders, (3) a specialized recruitment nurse, and (4) standardization of wording across all study communications. Results: From an eligible pool of 607 patients, the PCT enrolled 461 patients over 26 months. Twenty percent of patients referred to the palliative care service were enrolled (76% of those eligible after screening). Several common barriers were minimized; among those who declined participation, family disinterest was uncommon (5%), as was the perception of burden imposed (4%). Conclusion: Challenges to clinical trial recruitment in palliative care are significant but not insurmountable. A carefully crafted recruitment and retention protocol can be effective. Our experience with designing and deploying a social-marketing-based protocol shows the benefits of such an approach. Copyright © 2013 by American Society of Clinical Oncology.	en_US
dc.relation.ispartof	Journal of Oncology Practice	en_US
dc.relation.isbasedon	10.1200/JOP.2013.000996	en_US
dc.subject.classification	Oncology & Carcinogenesis	en_US
dc.subject.mesh	Humans	en_US
dc.subject.mesh	Neoplasms	en_US
dc.subject.mesh	Pain	en_US
dc.subject.mesh	Palliative Care	en_US
dc.subject.mesh	Attitude to Health	en_US
dc.subject.mesh	Patient Selection	en_US
dc.subject.mesh	Social Marketing	en_US
dc.subject.mesh	Clinical Trials as Topic	en_US
dc.subject.mesh	Randomized Controlled Trials as Topic	en_US
dc.subject.mesh	Pain Management	en_US
dc.title	Overcoming recruitment challenges in palliative care clinical trials	en_US
dc.type	Journal Article
utslib.citation.volume	6	en_US
utslib.citation.volume	9	en_US
utslib.for	1112 Oncology and Carcinogenesis	en_US
pubs.embargo.period	Not known	en_US
pubs.organisational-group	/University of Technology Sydney
pubs.organisational-group	/University of Technology Sydney/Faculty of Health
pubs.organisational-group	/University of Technology Sydney/Faculty of Health/IMPACCT
utslib.copyright.status	open_access
pubs.issue	6	en_US
pubs.publication-status	Published	en_US
pubs.volume	9	en_US

Abstract:

Purpose: Palliative care is increasingly viewed as a necessary component of cancer care, especially for patients with advanced disease. Rigorous clinical trials are thus needed to build the palliative care evidence base, but clinical research - especially participant recruitment - is difficult. Major barriers include (1) patient factors, (2) "gatekeeping," and (3) ethical concerns. Here we discuss an approach to overcoming these barriers, using the Palliative Care Trial (PCT) as a case study. Patients and Methods: The PCT was a 2 x 2 x 2 factorial randomized controlled trial (RCT) of different service delivery models to improve pain control in the palliative setting. It used a recruitment protocol that fused evidence-based strategies with principles of "social marketing," an approach involving the systematic application of marketing techniques. Main components included (1) an inclusive triage algorithm, (2) information booklets targeting particular stakeholders, (3) a specialized recruitment nurse, and (4) standardization of wording across all study communications. Results: From an eligible pool of 607 patients, the PCT enrolled 461 patients over 26 months. Twenty percent of patients referred to the palliative care service were enrolled (76% of those eligible after screening). Several common barriers were minimized; among those who declined participation, family disinterest was uncommon (5%), as was the perception of burden imposed (4%). Conclusion: Challenges to clinical trial recruitment in palliative care are significant but not insurmountable. A carefully crafted recruitment and retention protocol can be effective. Our experience with designing and deploying a social-marketing-based protocol shows the benefits of such an approach. Copyright © 2013 by American Society of Clinical Oncology.

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http://hdl.handle.net/10453/117421