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abstract:
The association of financial difficulties with clinical outcomes in cancer patients: secondary analysis of 16 academic prospective clinical trials conducted in Italy
Background Cancer may
cause financial difficulties, but its impact in countries with public
health systems is unknown. We evaluated
the association of financial difficulties with
clinical outcomes of cancer patients enrolled in academic clinical
trials performed
within the Italian public health system.
Patients and methods
Data were pooled from 16 prospective multicentre trials in lung, breast
or ovarian cancer, using the EORTC quality of life
(QOL) C30 questionnaire. Question 28 scores
financial difficulties related to disease or treatment in four
categories from
‘not at all’ to ‘very much’. We defined
financial burden (FB) as any financial difficulty reported at baseline
questionnaire,
and financial toxicity (FT) as score worsening
in a subsequent questionnaire. We investigated (i) the association of FB
with
clinical outcomes (survival, global QOL response
[questions 29/30] and severe toxicity), and (ii) the association of FT
with
survival. Multivariable analyses were performed
using logistic regression models or the Cox model adjusting for trial,
gender,
age, region and period of enrolment, baseline
global QOL and, where appropriate, FB and global QOL response. Results
are reported
as odds ratio (OR) or hazard ratio (HR) with 95%
confidence intervals (CI).
Results At baseline 26% of the 3670 study patients reported FB, significantly correlated with worse baseline global QOL. FB was not
associated with risks of death (HR 0.94) and severe toxicity (OR 0.90) but was predictive of a higher chance of worse global QOL response (OR 1.35). During treatment, 2735 (74.5%) patients filled in subsequent questionnaires and 616 (22.5%) developed FT that was
significantly associated with an increased risk of death (HR 1.20). Several sensitivity analyses confirmed these findings.
Conclusion Even in a public health system, financial difficulties are associated with relevant cancer patients outcomes like QOL and
survival.
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