Clinical trial NCT05104632: Financial Toxicity in Breast Cancer Surgery
Official title: Financial Toxicity in Surgical Breast Cancer Patients: A Prospective, Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer
Keywords: Financial toxicity
Breast cancer
Lumpectomy
Mastectomy
Breast reconstruction
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: St. Joseph's Healthcare Hamilton
name: Juravinski Cancer Center
First posted: 2021-11-03
Enrollment: 630
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women undergoing surgery for breast cancer or risk reduction (e.g., BRCA) including both breast conservation or mastectomy, with or without reconstruction.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* Female
* Have an indication for surgical treatment of breast cancer
* 18 years of age or older
* Able to understand and communicate in English
* Have access to email and internet and are able to fill out an electronic survey

Exclusion Criteria:

- Patients will be excluded if they have recurrent or metastatic disease

Primary outcomes:
measure: Financial Toxicity (FT)
timeFrame: 12 months
Secondary outcomes:
measure: Financial Toxicity (FT)
timeFrame: Baseline, 6 months
measure: Satisfaction with Breasts
timeFrame: Baseline, 6 months, 12 months
measure: Psychosocial Well-Being
timeFrame: Baseline, 6 months, 12 months
measure: Satisfaction with Surgeon
timeFrame: Baseline, 6 months, 12 months
measure: Quality of Life (mental and physical health)
timeFrame: Baseline, 6 months, 12 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Juravinski Hospital
state: Ontario
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster University
name: Christopher J Coroneos, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: