Financial Toxicity in Breast Cancer Surgery

NCT05104632 | Active Not Recruiting

• 1 other identifier: 131916
• Study Type: observational
• Target: 630
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer

Keywords

Financial toxicity; Breast cancer; Lumpectomy; Mastectomy; Breast reconstruction

Outcome Measures

Primary Outcomes (1)

• Financial Toxicity (FT)

  FT will be assessed using the COmprehensive Score for financial Toxicity (COST). The COST measure is an 11-item cancer-specific patient-reported outcome measure. Each item is scored on a 0 to 4-point Likert scale, where a lower total score represents greater financial distress.

  12 months

Secondary Outcomes (5)

• Financial Toxicity (FT)

  Baseline, 6 months

• Satisfaction with Breasts

  Baseline, 6 months, 12 months

• Psychosocial Well-Being

  Baseline, 6 months, 12 months

• Satisfaction with Surgeon

  Baseline, 6 months, 12 months

• Quality of Life (mental and physical health)

  Baseline, 6 months, 12 months

Study Arms (3)

Breast conserving surgery only

Patients who receive breast conserving surgery.

Mastectomy only

Patients who receive mastectomy surgery.

Mastectomy & breast reconstruction

Patients who receive mastectomy and breast reconstruction.

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Female
• Have an indication for surgical treatment of breast cancer
• 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

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead
• St. Joseph's Healthcare Hamilton: collaborator
• Juravinski Cancer Center: collaborator

Study Sites (2)

Juravinski Hospital

Hamilton, Ontario, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms; Financial Stress

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Christopher J Coroneos, MD, MSc

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: November 3, 2021
• Study Start: July 18, 2022
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)