Background:Radspherin®is a novel α-emitting radiopharmaceutical administered intraperitoneally following complete cytoreductive surgery and hyperthermic intraperitoneal chemotherapy (CRS-HIPEC) for peritoneal metastases. It delivers short-range radiation aimed at eliminating residual microscopic disease. This qualitative study explored how participants with colorectal cancer experienced participating in an early-phase clinical trial involving CRS-HIPEC followed by Radspherin®.Materials and Methods:Semi-structured interviews were conducted with ten participants enrolled in a phase 1/2a trial involving CRS-HIPEC and intraperitoneal Radspherin®. The analysis was guided by a phenomenological and interpretive approach using reflexive thematic analysis.Results:Participants expressed a strong sense of motivation and hope tied specifically to receiving Radspherin®, which they perceived as an opportunity to improve their prognosis. Many also viewed participation as a contribution to future cancer research. None attributed complications or side effects to Radspherin®. Clear and supportive verbal communication from healthcare professionals was highly valued, while the written information was described as overwhelming. Despite fears of recurrence, most participants remained optimistic about regaining a meaningful life. While experiences with Radspherin®were largely positive, participants also described pain, fatigue, and prolonged recovery related to CRS-HIPEC, including ongoing functional and psychosocial challenges.Conclusions:Participants associated Radspherin®with hope and a therapeutic benefit but did not link it to their adverse events. Their willingness to participate in experimental treatment was shaped by trust in clinicians, clear communication, and a desire for extended survival. However, the burden of CRS-HIPEC-related side effects underscores the importance of tailored follow-up and support.
背景:Radspherin®是一种新型的α-发射放射性药物,用于腹膜转移瘤患者在完全肿瘤细胞减灭术联合腹腔热灌注化疗后腹腔内给药。该药物通过短程辐射旨在消除残留的微小病灶。本定性研究探讨了结直肠癌患者参与一项早期临床试验的体验,该试验涉及CRS-HIPEC治疗后接受Radspherin®治疗。
材料与方法:对参与1/2a期临床试验(涉及CRS-HIPEC及腹腔内Radspherin®治疗)的十名患者进行半结构化访谈。采用现象学与解释学指导下的反思性主题分析法进行数据分析。
结果:参与者表达了与接受Radspherin®治疗密切相关的强烈动机和希望,他们将其视为改善预后的机遇。许多人也将参与试验视为对未来癌症研究的贡献。无人将并发症或副作用归因于Radspherin®。医疗专业人员清晰而支持性的言语沟通受到高度重视,而书面信息则被描述为令人难以消化。尽管担心复发,大多数参与者对重获有意义的生活仍持乐观态度。虽然Radspherin®的治疗体验总体积极,但参与者也描述了与CRS-HIPEC相关的疼痛、疲劳及恢复期延长等问题,包括持续存在的功能和社会心理挑战。
结论:参与者将Radspherin®与希望和治疗获益相联系,但未将其与不良事件关联。他们参与实验性治疗的意愿源于对临床医生的信任、清晰的医患沟通以及对延长生存期的渴望。然而,CRS-HIPEC相关副作用带来的负担凸显了个体化随访与支持的重要性。