Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05104632 |
| Other study ID # |
131916 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 18, 2022 |
| Est. completion date |
February 1, 2025 |
Study information
| Verified date |
March 2023 |
| Source |
McMaster University |
| Contact |
Christopher J Coroneos, MD, MSc |
| Phone |
905-521-2100 |
| Email |
coronec[@]mcmaster.ca |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The purpose of this study is to evaluate financial toxicity, or financial harm, in breast
cancer patients. The study will follow patients throughout their cancer treatment. The study
investigators will measure if patients are experiencing financial toxicity and if it changes
throughout treatment, and whether it's associated with different cancers, treatments, or
demographics. Also, the study investigators will measure if financial toxicity impacts other
areas of life (e.g., well-being, satisfaction). Finally, patients will be asked to estimate
how much money they expect to spend on out-of-pocket expenses during their treatment and how
their finances and employment status have changed since their cancer diagnosis.
Description:
One in three breast cancer patients experiences treatment-related, cost-associated distress.
This financial harm is termed "financial toxicity" (FT). FT is the strongest independent risk
factor for diminished quality of life and patient-reported outcomes (PROs) among cancer
patients. The present study will be the first prospective cohort study examining FT in breast
cancer patients in Canada, or any other publicly-funded healthcare system.
The primary objective is to detect the prevalence and trajectory of FT using a validated
instrument and its association with patient and treatment-related characteristics. The
secondary objective is to assess the effects of financial toxicity on patient-reported
quality of life, well-being, and satisfaction. The tertiary objective is to assess patients'
baseline cost expectations for reconstructive surgery, actual out-of-pocket spending, private
insurance or workplace benefits expenditure, and employment status, over the course of
treatment.
Participants will be recruited at their consultation with the general surgeon, will consent
to be observed for up to 1 year and be asked to complete a series of validated
questionnaires, at baseline, 6 months, and 12 months.
The primary outcome is financial toxicity (FT), assessed using the COmprehensive Score for
financial Toxicity (COST), a validated patient-reported outcome measure that uses a 12 item,
five-point Likert scale type.
The secondary outcomes include (1) well-being and satisfaction, as measured by the BREAST-Q,
(2) quality of life as measured by the 12-Item Short Form Health Survey (12-SF), (3)
patient-level (age, co-morbidities, stage, socioeconomic status) and treatment-associated
(complications, type of breast surgery, decision to have reconstruction, type of
reconstruction), and (4) baseline cost expectations, out-of-pocket spending, private
insurance or workplace benefits expenditure, and employment status, over the course of
treatment.
Multivariate regression will be used to identify patient and treatment level factors
associated with financial toxicity. First, the association between the COST scores and each
survey question response, patient characteristic, and treatment factor will be determined. A
stepwise linear regression will be completed with backward elimination to generate a list of
co-variates based on their significance level. All variables in the final selected model has
a significance level < 0.1. Other data will be characterized the study samples by presenting
the means, standard deviations, and medians for continuous variables and frequencies for
categorical variables.
