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Background: Few studies have explored in depth the experiences of patients with advanced cancer who are participating in clinical investigational medicinal product trials. However, integrated qualitative studies in such trials are needed to enable a broader evaluation of patient experiences in the trial, with important ethical and practical implications for the design and conduct of similar trials and treatment regimes in the future.

Methods: Ten participants were recruited from the control and intervention arms of FRAGMATIC: a non-placebo trial for patients with advanced lung cancer. Participants were interviewed at up to three time points during their time in the trial. Interviews were analysed using Interpretive Phenomenological Analysis.

Results: Patients were motivated to join the trial out of hope of medical benefit and altruism. Understanding of randomisation was mixed and in some cases poor, as was appreciation of trial purpose and equipoise. The trial was acceptable to and evaluated positively by most participants; participants receiving the intervention focused on the potential treatment benefits they hoped they would receive, whilst participants in the control arm found alternative reasons, such as altruism, personal fulfilment and positive attention, to commit to and perceive benefits from the trial. However, whilst experiences were generally very positive, poor understanding, limited engagement with trial information and focus on treatment benefits amongst some participants give cause for concern.

Conclusions: By exploring longitudinally the psychological, emotional and cognitive domains of trial participation, we consider potential harms and benefits of participation in non-placebo trials amongst patients with advanced lung cancer and identify several implications for future research with and care for patients with advanced cancer.

Trial Registration: ISRCTN80812769 . Registered on 8 July 2005.

Titel:	"I didn't really understand it, I just thought it'd help": exploring the motivations, understandings and experiences of patients with advanced lung cancer participating in a non-placebo clinical IMP trial.
Autor/in / Beteiligte Person:	Harrop, E ; Noble, S ; Edwards, M ; Sivell, S ; Moore, B ; Nelson, A
Link:	Zum Volltext
Zeitschrift:	Trials, Jg. 17 (2016-07-20), Heft 1, S. 329
Veröffentlichung:	[London] : BioMed Central, 2006-, 2016
Medientyp:	academicJournal
ISSN:	1745-6215 (electronic)
DOI:	10.1186/s13063-016-1460-8
Schlagwort:	Female Humans Lung Neoplasms psychology Male Lung Neoplasms therapy Motivation Patient Selection
Sonstiges:	Nachgewiesen in: MEDLINE Sprachen: English Corporate Authors: FRAGMATIC Trial Management Group (TMG) Publication Type: Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't Language: English [Trials] 2016 Jul 20; Vol. 17 (1), pp. 329. <i>Date of Electronic Publication: </i>2016 Jul 20. MeSH Terms: Motivation* ; Patient Selection* ; Lung Neoplasms / *therapy ; Female ; Humans ; Lung Neoplasms / psychology ; Male References: Control Clin Trials. 1999 Apr;20(2):149-71. (PMID: 10227415) ; BMJ. 2002 Oct 5;325(7367):766-70. (PMID: 12364308) ; Cancer. 2010 Aug 1;116(15):3702-11. (PMID: 20564120) ; BMJ. 2003 May 3;326(7396):980-1. (PMID: 12727776) ; Soc Sci Med. 2006 May;62(9):2279-90. (PMID: 16290917) ; BMJ Support Palliat Care. 2015 Dec 8;:null. (PMID: 26647042) ; Trials. 2012 Nov 29;13:228. (PMID: 23190503) ; Hastings Cent Rep. 1987 Apr;17(2):20-4. (PMID: 3294743) ; J Clin Epidemiol. 2001 Mar;54(3):217-24. (PMID: 11223318) ; Trials. 2011 Mar 15;12:78. (PMID: 21406089) ; Eur J Cancer Care (Engl). 2002 Sep;11(3):220-4. (PMID: 12296842) ; Eur J Cancer Care (Engl). 1996 Jun;5(2):90-5. (PMID: 8716204) ; Control Clin Trials. 2003 Jun;24(3):272-82. (PMID: 12757993) ; BMC Cancer. 2009 Oct 06;9:355. (PMID: 19807917) ; Trials. 2013 Oct 09;14 :325. (PMID: 24107437) ; Int J Palliat Nurs. 2002 Aug;8(8):376-80. (PMID: 12271258) ; Trials. 2016 Jan 19;17 :35. (PMID: 26787177) ; Trials. 2014 Oct 22;15:402. (PMID: 25336193) ; J Gen Intern Med. 2005 Jun;20(6):531-5. (PMID: 15987329) ; Oncol Nurs Forum. 2010 Mar;37(2):E124-32. (PMID: 20189911) ; BMJ. 2008 Sep 29;337:a1655. (PMID: 18824488) ; Health Expect. 2007 Sep;10(3):248-58. (PMID: 17678513) ; J Health Psychol. 2002 Mar;7(2):125-30. (PMID: 22114232) ; BMJ Open. 2013 Jun 20;3(6):null. (PMID: 23794542) ; Patient Educ Couns. 2008 Nov;73(2):313-7. (PMID: 18691845) ; J Clin Oncol. 2016 Feb 10;34(5):488-94. (PMID: 26700124) ; Trials. 2014 Apr 15;15:126. (PMID: 24731249) ; Soc Sci Med. 2002 Sep;55(5):709-19. (PMID: 12190265) ; BMC Complement Altern Med. 2009 Jun 18;9:18. (PMID: 19538715) ; Hastings Cent Rep. 2003 May-Jun;33(3):19-28. (PMID: 12854452) ; IRB. 2006 Jul-Aug;28(4):13-9. (PMID: 17036434) ; J Pain Symptom Manage. 2009 Jun;37(6):1078-85. (PMID: 19419837) ; Health Technol Assess. 2015 Oct;19(83):vii-xxiii, 1-93. (PMID: 26490434) ; Soc Sci Med. 1997 Nov;45(9):1337-55. (PMID: 9351153) Grant Information: MCCC-FCO-11-C United Kingdom MCCC_ Marie Curie Contributed Indexing: Keywords: Consent; Lung cancer; Qualitative; RCT; Randomisation Molecular Sequence: ISRCTN ISRCTN80812769 Entry Date(s): Date Created: 20160722 Date Completed: 20171214 Latest Revision: 20220129 Update Code: 20231215 PubMed Central ID: PMC4955155

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"I didn't really understand it, I just thought it'd help": exploring the motivations, understandings and experiences of patients with advanced lung cancer participating in a non-placebo clinical IMP trial.