Mooney-Doyle Kim, Knafl Kathleen A, Huang Liming, Wallen Gwenyth R, Ulrich Connie M
Department of Family and Community Health, University of Maryland School of Nursing, Baltimore, MD, USA.
School of Nursing, University of North Carolina, Chapel Hill, Chapel Hill, NC, USA.
J Psychosoc Oncol. 2025;43(1):88-104. doi: 10.1080/07347332.2024.2366996. Epub 2024 Jun 22.
To advance oncology treatment for adults, comprehensive understanding of how and why people decide to enroll in, remain in, and withdraw from cancer clinical trials is needed. While quantitative findings provide insights into these benefits and burdens, they provide limited understanding of how adults with cancer appraise their situation and approach decisions to undertake a clinical trial. The goal of this mixed methods analysis was to conceptualize participants' assessment of benefits and burdens related to cancer clinical trial participation.
This sub-group analysis of 21 participants was part of a larger sequential, explanatory mixed methods study. We used Creamer's integrated approach to linking quantitative and qualitative data to assess convergence, with qualitative data explaining quantitative results. Participants were grouped into four categories based on quantitative benefit/burden scores and thematic analysis of their qualitative data was used to describe these categories.
Across groups participants varied in descriptions of benefits and burdens of cancer clinical trial participation and reasons for participating. Those reporting high benefit/low burden described "seizing the opportunity to participate;" those reporting low benefit/low burden described "taking responsibility" through trial participation; those reporting low benefit/high burden described how they were "willing to endure," and those with high benefit/high burden emphasized "deciding to act."
Participants' qualitative descriptions of benefits and burdens were more nuanced and dynamic than reflected in their quantitative ratings. Thus, current measures may be missing important concepts, such as logistic challenges of trial participation. Our results have implications for consenting procedures and decisional support guidance offered to patients and their caregivers.
为推进成人肿瘤治疗，需要全面了解人们如何以及为何决定参加、继续参与和退出癌症临床试验。虽然定量研究结果能洞察这些益处和负担，但对于癌症成人患者如何评估自身情况以及做出参与临床试验的决策，其提供的理解有限。这项混合方法分析的目的是对参与者对与癌症临床试验参与相关的益处和负担的评估进行概念化。
对21名参与者的亚组分析是一项更大规模的序列式、解释性混合方法研究的一部分。我们使用克里默的综合方法将定量和定性数据相联系，以评估数据的趋同性，用定性数据解释定量结果。根据定量的益处/负担得分将参与者分为四类，并通过对其定性数据的主题分析来描述这些类别。
在各个组中，参与者对癌症临床试验参与的益处和负担的描述以及参与原因各不相同。那些报告高益处/低负担的人描述为“抓住参与机会”；那些报告低益处/低负担的人描述为通过参与试验“承担责任”；那些报告低益处/高负担的人描述了他们如何“愿意忍受”，而那些高益处/高负担的人强调“决定行动”。
参与者对益处和负担的定性描述比其定量评分所反映的更为细致入微和动态变化。因此，当前的测量方法可能遗漏了重要概念，如试验参与的后勤挑战。我们的结果对向患者及其护理人员提供的知情同意程序和决策支持指导具有启示意义。
