Decision-making and autonomy among participants in early-phase cancer immunotherapy trials: a qualitative study

doi:10.1186/s12885-024-12119-7

. 2024 Mar 25;24(1):373.

doi: 10.1186/s12885-024-12119-7.

Decision-making and autonomy among participants in early-phase cancer immunotherapy trials: a qualitative study

Jonathan Avery^#^{1

2}, Jennifer A H Bell^#^{3

4

5

6

7}, Khotira Baryolay², Gary Rodin^{2

8

9

10

11}, Rinat Nissim^{2

9}, Lynda G Balneaves^#¹²

Affiliations

¹ School of Nursing, University of British Columbia, Vancouver, BC, Canada.
² Department of Supportive Care Research, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
³ Department of Supportive Care Research, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada. Jennifer.bell2@uhn.ca.
⁴ Department of Clinical and Organizational Ethics, University Health Network, Toronto, ON, Canada. Jennifer.bell2@uhn.ca.
⁵ The Institute for Education Research, University Health Network, Toronto, ON, Canada. Jennifer.bell2@uhn.ca.
⁶ Department of Psychiatry and Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada. Jennifer.bell2@uhn.ca.
⁷ Princess Margaret Cancer Centre, Department of Supportive Care, Research Division, 700 Bay St., 23rd Floor, Toronto, ON, M5G 1Z6, Canada. Jennifer.bell2@uhn.ca.
⁸ Global Institute of Psychosocial, Palliative and End-of-Life Care (GIPPEC), Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
⁹ Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
¹⁰ Cancer Experience, University Health Network Cancer Program, University Health Network, Toronto, ON, Canada.
¹¹ Princess Margaret Research Institute, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
¹² Rady Faculty of Health Sciences, College of Nursing, University of Manitoba, Winnipeg, MB, Canada.

^# Contributed equally.

PMID: 38528488
PMCID: PMC10962144
DOI: 10.1186/s12885-024-12119-7

Decision-making and autonomy among participants in early-phase cancer immunotherapy trials: a qualitative study

Jonathan Avery et al. BMC Cancer. 2024.

. 2024 Mar 25;24(1):373.

doi: 10.1186/s12885-024-12119-7.

Authors

Jonathan Avery^#^{1

2}, Jennifer A H Bell^#^{3

4

5

6

7}, Khotira Baryolay², Gary Rodin^{2

8

9

10

11}, Rinat Nissim^{2

9}, Lynda G Balneaves^#¹²

Affiliations

¹ School of Nursing, University of British Columbia, Vancouver, BC, Canada.
² Department of Supportive Care Research, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
³ Department of Supportive Care Research, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada. Jennifer.bell2@uhn.ca.
⁴ Department of Clinical and Organizational Ethics, University Health Network, Toronto, ON, Canada. Jennifer.bell2@uhn.ca.
⁵ The Institute for Education Research, University Health Network, Toronto, ON, Canada. Jennifer.bell2@uhn.ca.
⁶ Department of Psychiatry and Dalla Lana School of Public Health, University of Toronto, Toronto, ON, Canada. Jennifer.bell2@uhn.ca.
⁷ Princess Margaret Cancer Centre, Department of Supportive Care, Research Division, 700 Bay St., 23rd Floor, Toronto, ON, M5G 1Z6, Canada. Jennifer.bell2@uhn.ca.
⁸ Global Institute of Psychosocial, Palliative and End-of-Life Care (GIPPEC), Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
⁹ Department of Psychiatry, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
¹⁰ Cancer Experience, University Health Network Cancer Program, University Health Network, Toronto, ON, Canada.
¹¹ Princess Margaret Research Institute, Princess Margaret Cancer Centre, University Health Network, Toronto, ON, Canada.
¹² Rady Faculty of Health Sciences, College of Nursing, University of Manitoba, Winnipeg, MB, Canada.

^# Contributed equally.

PMID: 38528488
PMCID: PMC10962144
DOI: 10.1186/s12885-024-12119-7

Abstract

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: 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: 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: 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.

Keywords: Cancer clinical trials; Cancer immunotherapy; Early-phase trials; Patient decision making; Qualitative research; Research ethics.

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Conflict of interest statement

The authors declare no competing interests.

References

1. 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. - DOI - PubMed
1. 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. - DOI - PMC - PubMed
1. 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. - DOI
1. 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. - DOI - PMC - PubMed
1. 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. - DOI - PubMed

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[1] 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. - DOI - PubMed

[2] 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. - DOI - PubMed

[3] 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. - DOI - PMC - PubMed

[4] 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. - DOI - PMC - PubMed

[5] 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. - DOI

[6] 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. - DOI

[7] 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. - DOI - PMC - PubMed

[8] 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. - DOI - PMC - PubMed

[9] 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. - DOI - PubMed

[10] 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. - DOI - PubMed

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Decision-making and autonomy among participants in early-phase cancer immunotherapy trials: a qualitative study

Affiliations

Decision-making and autonomy among participants in early-phase cancer immunotherapy trials: a qualitative study

Authors

Affiliations

Abstract

Conflict of interest statement

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References

MeSH terms

Grants and funding

LinkOut - more resources

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Medical

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Abstract

Conflict of interest statement

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Related information

Grants and funding

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Medical

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