Breast CancerNCT05104632
Financial Toxicity in Breast Cancer Surgery
An observational study of Breast Cancer, run by McMaster University at 2 sites in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 630 participants
- Where
- 2 sitesCanada
- Study dates
- 18 Jul 2022to 1 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women undergoing surgery for breast cancer or risk reduction (e.g., BRCA) including both breast conservation or mastectomy, with or without reconstruction.
Who may be able to join
- 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
Who cannot join
- Patients will be excluded if they have recurrent or metastatic disease
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Juravinski Hospital
Hamilton, Ontario
St. Joseph's Healthcare Hamilton
Hamilton, Ontario
About this study
Official title: Financial Toxicity in Surgical Breast Cancer Patients: A Prospective, Multicenter Cohort Study
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.
Read the 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
- Keywords
- Financial toxicity, Breast cancer, Lumpectomy, Mastectomy, Breast reconstruction
- Medical subject headings
- Breast Neoplasms, Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (5)
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.
Measured: Baseline, 6 months
Satisfaction with Breasts
This will be measured using the BREAST-Q questionnaire; Satisfaction with Breast Module. All questions are answered on Likert scales (scored 1-4). This module varies based on the type of breast surgery the patient underwent (mastectomy only, breast conserving surgery, or reconstruction). The answers of this section are totalled and compared to the equivalent Rasch transformed score. Zero represents the worst possible score and 100 represents the best.
Measured: Baseline, 6 months, 12 months
Psychosocial Well-Being
This will be measured using the BREAST-Q questionnaire; Psychosocial Well-Being Module. All questions are answered on Likert scales (scored 1-5). The answers this section are totalled and compared to the equivalent Rasch transformed score. Zero represents the worst possible score and 100 represents the best.
Measured: Baseline, 6 months, 12 months
Satisfaction with Surgeon
This will be measured using the BREAST-Q questionnaire; Satisfaction with Surgeon Module. All questions are answered on Likert scales (scored 0-4). The answers this section are totalled and compared to the equivalent Rasch transformed score. Zero represents the worst possible score and 100 represents the best.
Measured: Baseline, 6 months, 12 months
Quality of Life (mental and physical health)
Quality of life, will be assessed using the 12-Item Short Form Health Survey (12-SF) that evaluates overall physical and mental health. The SF-12 is a general health patient-reported outcome measure that has 12 items, is reported 0 to 100 for two domains. Higher scores represent better quality of life.
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2021
- Study start18 Jul 2022
- Primary completion1 Feb 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 630 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton, Juravinski Cancer Center
- Responsible party
- Sponsor
- Investigators
- Christopher J Coroneos, MD, MSc, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05104632
- Sponsor's protocol ID
- 131916
- Status last verified
- Jun 2025
- First submitted
- 12 Oct 2021
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Financial Toxicity in Surgical Breast Cancer Patients: A Prospective, Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT05104632
- Acronym / sponsor ID
- 131916
- Conditions
- Breast Cancer
- Keywords
- Financial toxicity, Breast cancer, Lumpectomy, Mastectomy, Breast reconstruction
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 630 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- St. Joseph's Healthcare Hamilton, Juravinski Cancer Center
- Study start
- 18 Jul 2022 (actual)
- Primary completion
- 1 Feb 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 3 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women undergoing surgery for breast cancer or risk reduction (e.g., BRCA) including both breast conservation or mastectomy, with or without reconstruction.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patients will be excluded if they have recurrent or metastatic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Financial Toxicity (FT)
Time frame: 12 months
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.
5 secondary outcomes
Financial Toxicity (FT)
Time frame: Baseline, 6 months
Satisfaction with Breasts
Time frame: Baseline, 6 months, 12 months
Psychosocial Well-Being
Time frame: Baseline, 6 months, 12 months
Satisfaction with Surgeon
Time frame: Baseline, 6 months, 12 months
Quality of Life (mental and physical health)
Time frame: Baseline, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christopher J Coroneos, MD, MSc principal investigator
McMaster University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by McMaster University at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Financial Toxicity (FT) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.