Financial Toxicity in Breast Cancer Surgery

NCT ID: NCT05104632

Last Updated: 2025-06-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 630 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-07-18
• Study Completion Date: 2027-02-01

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Breast conserving surgery only

Patients who receive breast conserving surgery.

No interventions assigned to this group

Mastectomy only

Patients who receive mastectomy surgery.

No interventions assigned to this group

Mastectomy & breast reconstruction

Patients who receive mastectomy and breast reconstruction.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role: collaborator

Juravinski Cancer Center

OTHER

Sponsor Role: collaborator

McMaster University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christopher J Coroneos, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

McMaster University

Locations

Juravinski Hospital

Hamilton, Ontario, Canada

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

131916

Identifier Type: -

Identifier Source: org_study_id