Nothing to lose: a grounded theory study of patients' and healthcare professionals' perspectives of being involved in the consent process for oncology trials with non-curative intent.
Cancer
Clinical trial
Consent
Decision-making
Grounded theory
Neoplasms
Journal
BMC palliative care
ISSN: 1472-684X
Titre abrégé: BMC Palliat Care
Pays: England
ID NLM: 101088685
Informations de publication
Date de publication:
30 Oct 2020
30 Oct 2020
Historique:
received:
29
06
2020
accepted:
29
09
2020
entrez:
31
10
2020
pubmed:
1
11
2020
medline:
16
6
2021
Statut:
epublish
Résumé
Clinical cancer research trials may offer little or no direct clinical benefit to participants where a cure is no longer possible. As such, the decision-making and consent process for patient participation is often challenging. To gain understanding of how patients make decisions regarding clinical trial participation, from the perspective of both the patient and healthcare professionals involved. In-depth, face to face interviews using a grounded theory approach. This study was conducted in a regional Cancer Centre in the United Kingdom. Of the 36 interviews, 16 were conducted with patients with cancer that had non-curative intent and 18 with healthcare professionals involved in the consent process. 'Nothing to lose' was identified as the core category that underpinned all other data within the study. This highlighted the desperation articulated by participants, who asserted trial participation was the 'only hope in the room'. The decision regarding participation was taken within a 'trusting relationship' that was important to both patients and professionals. Both were united in their 'fight against cancer'. These two categories are critical in understanding the decision-making/consent process and are supported by other themes presented in the theoretical model. This study presents an important insight into the complex and ethically contentious situation of consent in clinical trials that have non-curative intent. It confirms that patients with limited options trust their doctor and frequently hold unrealistic hopes for personal benefit. It highlights a need for further research to develop a more robust and context appropriate consent process.
Sections du résumé
BACKGROUND
BACKGROUND
Clinical cancer research trials may offer little or no direct clinical benefit to participants where a cure is no longer possible. As such, the decision-making and consent process for patient participation is often challenging.
AIM
OBJECTIVE
To gain understanding of how patients make decisions regarding clinical trial participation, from the perspective of both the patient and healthcare professionals involved.
METHODS
METHODS
In-depth, face to face interviews using a grounded theory approach. This study was conducted in a regional Cancer Centre in the United Kingdom. Of the 36 interviews, 16 were conducted with patients with cancer that had non-curative intent and 18 with healthcare professionals involved in the consent process.
RESULTS
RESULTS
'Nothing to lose' was identified as the core category that underpinned all other data within the study. This highlighted the desperation articulated by participants, who asserted trial participation was the 'only hope in the room'. The decision regarding participation was taken within a 'trusting relationship' that was important to both patients and professionals. Both were united in their 'fight against cancer'. These two categories are critical in understanding the decision-making/consent process and are supported by other themes presented in the theoretical model.
CONCLUSION
CONCLUSIONS
This study presents an important insight into the complex and ethically contentious situation of consent in clinical trials that have non-curative intent. It confirms that patients with limited options trust their doctor and frequently hold unrealistic hopes for personal benefit. It highlights a need for further research to develop a more robust and context appropriate consent process.
Identifiants
pubmed: 33126874
doi: 10.1186/s12904-020-00661-7
pii: 10.1186/s12904-020-00661-7
pmc: PMC7602307
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
166Références
Health Expect. 2015 Dec;18(6):2570-83
pubmed: 24975503
Patient Educ Couns. 2006 Oct;63(1-2):104-9
pubmed: 16242898
IRB. 2004 Mar-Apr;26(2):1-8
pubmed: 15069970
J Cancer Educ. 2012 Jun;27(2):257-62
pubmed: 22271582
Trials. 2010 Mar 22;11:31
pubmed: 20307273
J Pain Symptom Manage. 2007 Jul;34(1 Suppl):S1-6
pubmed: 17544251
Br Med J. 1964 Jul 18;2(5402):177
pubmed: 14150898
Support Care Cancer. 2006 Apr;14(4):303-9
pubmed: 16633840
Nurs Sci Q. 1990 Winter;3(4):177-84
pubmed: 2250837
J Oncol Pract. 2017 Oct;13(10):e863-e873
pubmed: 28837373
J Adv Pharm Technol Res. 2013 Jul;4(3):134-40
pubmed: 24083200
Trials. 2018 Sep 29;19(1):528
pubmed: 30268150
Health Aff (Millwood). 2013 Feb;32(2):357-67
pubmed: 23381529
Eur J Cancer. 2001 Oct;37 Suppl 8:S153-9
pubmed: 11602381
Soc Sci Med. 2016 Jul;161:83-91
pubmed: 27261532
Kennedy Inst Ethics J. 2011 Sep;21(3):201-18
pubmed: 22073815
Nurs Clin North Am. 1985 Jun;20(2):379-91
pubmed: 3846980
JAMA. 1996 Nov 27;276(20):1662-6
pubmed: 8922453
J Clin Oncol. 1995 May;13(5):1062-72
pubmed: 7738612
J Clin Oncol. 2014 Oct 10;32(29):3229-35
pubmed: 25199753
SAGE Open Med. 2014 Apr 22;2:2050312114532456
pubmed: 26770726
IRB. 2003 Jan-Feb;25(1):11-6
pubmed: 12833900
J Med Ethics. 2011 Feb;37(2):74-80
pubmed: 21098797
Cochrane Database Syst Rev. 2015 Nov 27;(11):CD009736
pubmed: 26613337
Support Care Cancer. 2011 Aug;19(8):1227-38
pubmed: 20593202
Dimens Crit Care Nurs. 2010 Jul-Aug;29(4):173-4
pubmed: 20543620
MDM Policy Pract. 2019 Mar 28;4(1):2381468319840322
pubmed: 30944886
J Med Ethics. 2011 Sep;37(9):563-6
pubmed: 21551464
Eur J Cancer Care (Engl). 2002 Sep;11(3):220-4
pubmed: 12296842
Cancer. 2016 Nov 15;122(22):3501-3508
pubmed: 27716902
N Engl J Med. 2010 Aug 19;363(8):733-42
pubmed: 20818875
Support Care Cancer. 2017 Oct;25(10):3235-3242
pubmed: 28488050
Support Care Cancer. 2011 Mar;19(3):371-9
pubmed: 20333413
Eur J Cancer Care (Engl). 1998 Mar;7(1):15-22
pubmed: 9582747
Clin Trials. 2015 Dec;12(6):567-74
pubmed: 26319116