Objectives
Phase 1 (P1) trials support cancer patients with limited treatment options. Time Toxicity (TT), the days spent in contact with the healthcare system, is understudied in this cohort. This study examined TT and its impact on quality of life (QOL).
Sample and Setting
Thirteen patients undergoing P1 cancer trials were enrolled.
Procedures
This mixed methods study involved semi structured interviews and FACT-G questionnaires at baseline and follow up (12 weeks), and time diaries maintained throughout. Interviews were analysed thematically and refined using generative AI. Expected TT was calculated from the P1 patient informed consent forms (PICF) and interviews; actual TT from time diaries.
Results
Six themes were developed from the interviews: (1) Awareness of TT through informed consent and prior treatment experiences; (2) Contributors to TT including travel and inflexible trial processes; (3) Reduction of TT with trial progression and an underestimated cognitive toll; (4) TT had minimal impact on QOL, with disease progression and treatment effects having greater impact; (5) Management of TT was by the patient with support networks, and healthcare team who aided in minimising time burden; and (6) Personal Impact; trial seen as a worthwhile time investment, offering hope and purpose, and not a deterrent to participation.
Expected TT from the PICF (median 13 days, [11-19]) was significantly different to actual TT (median 25 days, [12-26]); (p value <0.01). TT estimates from patient interviews (median 24 days, [7-42]) was not significantly different to actual TT (p value = 0.95). The global QOL score (FACT-G) was preserved across timepoints (p value = 0.77).
Conclusions
Patients were well-informed about TT, which did not deter participation in P1 trials. PICFs underestimated TT, highlighting a discrepancy to be addressed. While cognitively fatiguing, the hope afforded outweighs time burden. Support networks and minimising time investment is key in managing TT.