Decision-making and autonomy among participants in early-phase cancer immunotherapy trials: a qualitative study.
Cancer clinical trials
Cancer immunotherapy
Early-phase trials
Patient decision making
Qualitative research
Research ethics
Journal
BMC cancer
ISSN: 1471-2407
Titre abrégé: BMC Cancer
Pays: England
ID NLM: 100967800
Informations de publication
Date de publication:
25 Mar 2024
25 Mar 2024
Historique:
received:
24
08
2023
accepted:
13
03
2024
medline:
26
3
2024
pubmed:
26
3
2024
entrez:
26
3
2024
Statut:
epublish
Résumé
Participants considering early-phase cancer clinical trials (CTs) need to understand the unique risks and benefits prior to providing informed consent. This qualitative study explored the factors that influence patients' decisions about participating in early-phase cancer immunotherapy CTs through the ethical lens of relational autonomy. Using an interpretive descriptive design, interviews were conducted with 21 adult patients with advanced cancer who had enrolled in an early-phase CT. Data was analyzed using relational autonomy ethical theory and constant comparative analysis. The extent to which participants perceived themselves as having a choice to participate in early-phase cancer immunotherapy CTs was a central construct. Perceptions of choice varied according to whether participants characterized their experience as an act of desperation or as an opportunity to receive a novel treatment. Intersecting psychosocial and structural factors influenced participants' decision making about participating in early-phase cancer immunotherapy trials. These relational factors included: (1) being provided with hope; (2) having trust; (3) having the ability to withdraw; and (4) timing constraints. Findings highlight the continuum of perceived choice that exists among patients with cancer when considering participation in early-phase cancer immunotherapy CTs. All participants were interpreted as exhibiting some degree of relational autonomy within the psychosocial and structural context of early-phase CT decision making. This study offers insights into the intersection of cancer care delivery, personal beliefs and values, and established CT processes and structures that can inform future practices and policies associated with early-phase cancer immunotherapy CTs to better support patients in making informed decisions.
Sections du résumé
BACKGROUND
BACKGROUND
Participants considering early-phase cancer clinical trials (CTs) need to understand the unique risks and benefits prior to providing informed consent. This qualitative study explored the factors that influence patients' decisions about participating in early-phase cancer immunotherapy CTs through the ethical lens of relational autonomy.
METHODS
METHODS
Using an interpretive descriptive design, interviews were conducted with 21 adult patients with advanced cancer who had enrolled in an early-phase CT. Data was analyzed using relational autonomy ethical theory and constant comparative analysis.
RESULTS
RESULTS
The extent to which participants perceived themselves as having a choice to participate in early-phase cancer immunotherapy CTs was a central construct. Perceptions of choice varied according to whether participants characterized their experience as an act of desperation or as an opportunity to receive a novel treatment. Intersecting psychosocial and structural factors influenced participants' decision making about participating in early-phase cancer immunotherapy trials. These relational factors included: (1) being provided with hope; (2) having trust; (3) having the ability to withdraw; and (4) timing constraints.
CONCLUSIONS
CONCLUSIONS
Findings highlight the continuum of perceived choice that exists among patients with cancer when considering participation in early-phase cancer immunotherapy CTs. All participants were interpreted as exhibiting some degree of relational autonomy within the psychosocial and structural context of early-phase CT decision making. This study offers insights into the intersection of cancer care delivery, personal beliefs and values, and established CT processes and structures that can inform future practices and policies associated with early-phase cancer immunotherapy CTs to better support patients in making informed decisions.
Identifiants
pubmed: 38528488
doi: 10.1186/s12885-024-12119-7
pii: 10.1186/s12885-024-12119-7
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
373Subventions
Organisme : CIHR
ID : 154143
Pays : Canada
Informations de copyright
© 2024. The Author(s).
Références
Lara PN, Higdon R, Lim N, Kwan K, Tanaka M, Lau DHM, et al. Prospective evaluation of Cancer clinical trial accrual patterns: identifying potential barriers to enrollment. J Clin Oncol. 2001;19(6):1728–33.
doi: 10.1200/JCO.2001.19.6.1728
pubmed: 11251003
Carlisle B, Kimmelman J, Ramsay T, MacKinnon N. Unsuccessful trial accrual and human subjects protections: an empirical analysis of recently closed trials. Clin Trials. 2015;12(1):77–83.
doi: 10.1177/1740774514558307
pubmed: 25475878
Bell Ja, Balneaves H, Kelly LG, Richardson MT. Report on a Delphi Process and workshop to improve accrual to Cancer clinical trials. Curr Oncol. 2016;23(2):125–30.
doi: 10.3747/co.23.3110
pmcid: 4834998
Juraskova I, Butow P, Lopez A, Seccombe M, Coates A, Boyle F, et al. Improving informed consent: pilot of a decision aid for women invited to participate in a breast cancer prevention trial (IBIS-II DCIS). Health Expect. 2008;11(3):252–62.
doi: 10.1111/j.1369-7625.2008.00498.x
pubmed: 18816321
pmcid: 5060455
Falagas ME, Korbila IP, Giannopoulou KP, Kondilis BK, Peppas G. Informed consent: how much and what do patients understand? Am J Surg. 2009;198(3):420–35.
doi: 10.1016/j.amjsurg.2009.02.010
pubmed: 19716887
Kimmelman J. Is participation in Cancer Phase I trials really therapeutic? J Clin Oncol. 2017;35(2):135–8.
doi: 10.1200/JCO.2016.67.9902
pubmed: 27646944
Truong TH, Weeks JC, Cook EF, Joffe S. Altruism among participants in cancer clinical trials. Clin Trials. 2011;8(5):616–23.
doi: 10.1177/1740774511414444
pubmed: 21813584
Abdoler E, Taylor H, Wendler D. The Ethics of phase 0 oncology trials. Clin Cancer Res. 2008;14(12):3692–7.
doi: 10.1158/1078-0432.CCR-08-0876
pubmed: 18559585
Daugherty CK, Banik DM, Janish L, Ratain MJ. Quantitative analysis of ethical issues in phase I trials: a survey interview study of 144 Advanced Cancer patients. IRB Ethics Hum Res. 2000;22(3):6.
doi: 10.2307/3564113
Cescon D, Siu LL. Cancer clinical trials: the rear-view Mirror and the Crystal Ball. Cell. 2017;168(4):575–8.
doi: 10.1016/j.cell.2017.01.027
pubmed: 28187280
Prowell TM, Theoret MR, Pazdur R. Seamless oncology-drug development. N Engl J Med. 2016;374(21):2001–3.
doi: 10.1056/NEJMp1603747
pubmed: 27074059
Sherman RE, Li J, Shapley S, Robb M, Woodcock J. Expediting Drug Development — the FDA’s new breakthrough therapy designation. N Engl J Med. 2013;369(20):1877–80.
doi: 10.1056/NEJMp1311439
pubmed: 24224621
Escritt K, Mann M, Nelson A, Harrop E. Hope and meaning-making in phase 1 oncology trials: a systematic review and thematic synthesis of qualitative evidence on patient-participant experiences. Trials. 2022;23(1):409.
doi: 10.1186/s13063-022-06306-9
pubmed: 35578308
pmcid: 9112562
Thorne S. Interpretive decision. In: Beck CT, editor. Routledge International Handbook of Qualitative Nursing Research. London: Routledge; 2013. pp. 295–306.
Bell JAH. Relational autonomy as a Theoretical Lens for Qualitative Health Research. IJFAB Int J Fem Approaches Bioeth. 2020;13(2):69–92.
Sherwin S. A relational approach to autonomy in health care. The politics of women’s health: Exploring Agency and Autonomy. Philadelphia: Temple University; 1998. pp. 19–47.
Meyers DT. Self, Society, and personal choice. New York, NY: Columbia University; 1989. pp. 19–47.
Nielsen ZE, Berthelsen CB. Cancer patients’ perceptions of factors influencing their decisions on participation in clinical drug trials: a qualitative meta-synthesis. J Clin Nurs. 2019;28(13–14):2443–61.
doi: 10.1111/jocn.14785
pubmed: 30673153
Corbin JM, Strauss AL. Basics of qualitative research: techniques and procedures for developing grounded theory. Thousand Oaks, CA: SAGE; 1998.
Morse J. Principles of Mixed Methods and Multimethod Research Design. In: Handbook of mixed methods in social and behavioral research. 2003.
Halpern J, Paolo D, Huang A. Informed consent for early-phase clinical trials: therapeutic misestimation, unrealistic optimism and appreciation. J Med Ethics. 2019;45(6):384–7.
doi: 10.1136/medethics-2018-105226
pubmed: 31189726
Cox AC, Fallowfield LJ, Jenkins VA. Communication and informed consent in phase 1 trials: a review of the literature. Support Care Cancer. 2006;14(4):303–9.
doi: 10.1007/s00520-005-0916-2
pubmed: 16633840
Sawyer C, Preston L, Taylor S, Davies M, Carter L, Krebs M et al. Oncology patients’ experiences in experimental medicine cancer trials: a qualitative study. BMJ Open. 2021;11(10).
Gregersen A, Birkelund T, Wolderslund R, Dahl Steffensen M, Ammentorp K. Patients’ experiences of the decision-making process for clinical trial participation. Nurs Health Sci. 2022;24(1):65–72.
doi: 10.1111/nhs.12933
Dunn LB, Wiley J, Garrett S, Hlubocky F, Daugherty C, Trupin L, et al. Interest in initiating an early phase clinical trial: results of a longitudinal study of advanced cancer patients. Psychooncology. 2017;26(10):1604–10.
doi: 10.1002/pon.4179
pubmed: 27233054
Swift T. Desperation may affect autonomy but not informed consent. AJOB Neurosci. 2011;2(1):45–6.
doi: 10.1080/21507740.2010.537293
pubmed: 21390293
pmcid: 3046626
Miller FG, Joffe S. Phase 1 oncology trials and informed consent. J Med Ethics. 2013;39(12):761–4.
doi: 10.1136/medethics-2012-100832
pubmed: 23161617
Shokar S, Buldo E, Siu LL, Hansen AR, Spreafico A, Doi J et al. Patient knowledge, attitudes, and expectations of cancer immunotherapies. J Clin Oncol. 2018;36(15).
Hauser DJ, Schwarz N. The War on Prevention II: Battle metaphors Undermine Cancer Treatment and Prevention and do not increase vigilance. Health Commun. 2020;35(13):1698–704.
doi: 10.1080/10410236.2019.1663465
pubmed: 31496298
Adashek JJ, LoRusso PM, Hong DS, Kurzrock R. Phase I trials as valid therapeutic options for patients with cancer. Nat Rev Clin Oncol. 2019;16(12):773–8.
doi: 10.1038/s41571-019-0262-9
pubmed: 31477881
pmcid: 6868302
Weber JS, Levit LA, Adamson PC, Bruinooge SS, Burris HA, Carducci MA, et al. Reaffirming and clarifying the American Society of Clinical Oncology’s Policy Statement on the critical role of phase I trials in Cancer Research and Treatment. J Clin Oncol. 2017;35(2):139–40.
doi: 10.1200/JCO.2016.70.4692
pubmed: 27893329
Horgan J. Scientific American Blog Network. [cited 2023 May 26]. The Cancer Industry: Hype vs. Reality. Available from: https://blogs.scientificamerican.com/cross-check/the-cancer-industry-hype-vs-reality/ .
Axicabtagene Ciloleucel for Large B-cell Lymphoma. Implementation and Ethics Project Protocol. CADTH Optimal Use Reports. Volume 9. Ottawa (ON): CADTH; 2019.
Abola MV, Prasad V. The Use of superlatives in Cancer Research. JAMA Oncol. 2016;2(1):139–41.
doi: 10.1001/jamaoncol.2015.3931
pubmed: 26512913
Vater LB, Donohue JM, Arnold R, White DB, Chu E, Schenker Y. What Are Cancer Centers Advertising to the Public? Ann Intern Med. 2014;160(12):813–20.
doi: 10.7326/M14-0500
pubmed: 24863081
pmcid: 4356527
Bell JAH, Kelly MT, Gelmon K, Chi K, Ho A, Rodney P, et al. Gatekeeping in cancer clinical trials in Canada: the ethics of recruiting the ideal patient. Cancer Med. 2020;9(12):4107–13.
doi: 10.1002/cam4.3031
pubmed: 32314549
pmcid: 7300392
Bellhouse S, Galvin L, Turner L, Taylor S, Davies M, Krebs M, et al. Phase I cancer trials: a qualitative study of specialist palliative care. BMJ Support Palliat Care. 2020;10(2):234–41.
doi: 10.1136/bmjspcare-2019-001919
pubmed: 31784463
Zimmermann C, Swami N, Krzyzanowska M, Hannon B, Leighl N, Oza A, et al. Early palliative care for patients with advanced cancer: a cluster-randomised controlled trial. Lancet. 2014;383(9930):1721–30.
doi: 10.1016/S0140-6736(13)62416-2
pubmed: 24559581
Woo JA, Maytal G, Stern TA. Clinical challenges to the delivery of end-of-Life Care. Prim Care Companion J Clin Psychiatry. 2006;8(6):367–72.
pubmed: 17245459
pmcid: 1764519
Oncology TL. Immunotherapy: hype and hope. Lancet Oncol. 2018;19(7):845.
doi: 10.1016/S1470-2045(18)30317-6
Bulaklak K, Gersbach CA. The once and future gene therapy. Nat Commun. 2020;11(1):5820.
doi: 10.1038/s41467-020-19505-2
pubmed: 33199717
pmcid: 7670458