Decision-making and autonomy among participants in early-phase cancer immunotherapy trials: a qualitative study
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 immunot...
| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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BMC
2024-03-01
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| Series: | BMC Cancer |
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| Online Access: | https://doi.org/10.1186/s12885-024-12119-7 |
| _version_ | 1797233515956273152 |
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| author | Jonathan Avery Jennifer A.H. Bell Khotira Baryolay Gary Rodin Rinat Nissim Lynda G. Balneaves |
| author_facet | Jonathan Avery Jennifer A.H. Bell Khotira Baryolay Gary Rodin Rinat Nissim Lynda G. Balneaves |
| author_sort | Jonathan Avery |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-04-24T16:17:24Z |
| format | Article |
| id | doaj.art-3e8a476a081b415184e9c3bbf3303e3f |
| institution | Directory Open Access Journal |
| issn | 1471-2407 |
| language | English |
| last_indexed | 2024-04-24T16:17:24Z |
| publishDate | 2024-03-01 |
| publisher | BMC |
| record_format | Article |
| series | BMC Cancer |
| spelling | doaj.art-3e8a476a081b415184e9c3bbf3303e3f2024-03-31T11:23:19ZengBMCBMC Cancer1471-24072024-03-0124111210.1186/s12885-024-12119-7Decision-making and autonomy among participants in early-phase cancer immunotherapy trials: a qualitative studyJonathan Avery0Jennifer A.H. Bell1Khotira Baryolay2Gary Rodin3Rinat Nissim4Lynda G. Balneaves5School of Nursing, University of British ColumbiaDepartment of Supportive Care Research, Princess Margaret Cancer Centre, University Health NetworkDepartment of Supportive Care Research, Princess Margaret Cancer Centre, University Health NetworkDepartment of Supportive Care Research, Princess Margaret Cancer Centre, University Health NetworkDepartment of Supportive Care Research, Princess Margaret Cancer Centre, University Health NetworkRady Faculty of Health Sciences, College of Nursing, University of ManitobaAbstract 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.https://doi.org/10.1186/s12885-024-12119-7Research ethicsPatient decision makingCancer clinical trialsEarly-phase trialsQualitative researchCancer immunotherapy |
| spellingShingle | Jonathan Avery Jennifer A.H. Bell Khotira Baryolay Gary Rodin Rinat Nissim Lynda G. Balneaves Decision-making and autonomy among participants in early-phase cancer immunotherapy trials: a qualitative study BMC Cancer Research ethics Patient decision making Cancer clinical trials Early-phase trials Qualitative research Cancer immunotherapy |
| title | Decision-making and autonomy among participants in early-phase cancer immunotherapy trials: a qualitative study |
| title_full | Decision-making and autonomy among participants in early-phase cancer immunotherapy trials: a qualitative study |
| title_fullStr | Decision-making and autonomy among participants in early-phase cancer immunotherapy trials: a qualitative study |
| title_full_unstemmed | Decision-making and autonomy among participants in early-phase cancer immunotherapy trials: a qualitative study |
| title_short | Decision-making and autonomy among participants in early-phase cancer immunotherapy trials: a qualitative study |
| title_sort | decision making and autonomy among participants in early phase cancer immunotherapy trials a qualitative study |
| topic | Research ethics Patient decision making Cancer clinical trials Early-phase trials Qualitative research Cancer immunotherapy |
| url | https://doi.org/10.1186/s12885-024-12119-7 |
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