A Longitudinal Study of the Trajectory of Financial Toxicity and Its Relationship With Symptom Burden in Breast Cancer Patients

Breast cancer has become the leading cause of global cancer incidence. With the improvement of treatment methods, some breast cancer patients have experienced different degrees of financial toxicity, which seriously affected the quality of life, treatment compliance and treatment outcomes of patients. Currently, there are some related studies on financial toxicity in breast cancer patients, but they are mainly cross-sectional studies, lacking the use of validated financial toxicity tools to measure the longitudinal change trajectory of financial toxicity. The financial toxicity of breast cancer patients may change dynamically with the treatment stage, expenditure and time, so it is necessary to conduct a rigorously designed prospective study to explore the trajectory of financial toxicity. In addition, previous studies have showed that financial toxicity may be associated with anxiety, distress, pain and overall symptom burden. However, the relevant evidence is currently limited. This study is designed as a prospective longitudinal study to explore the trajectory of financial toxicity and its influencing factors in breast cancer patients in China, and to focus on the relationship between symptom burden and financial toxicity, which will help clinicians identify potential high-risk populations, and provide a new perspective for future intervention programs.

Study Overview

• Status: Active, not recruiting
• Conditions: Financial Toxicity

• Study Type: Observational
• Enrollment (Actual): 485

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Fudan University Shanghai Cancer Center
  • Shenyang, China
    • The First Hospital of China Medical University
  • Wuhan, China
    • Wuhan Union Hospital
  • Xi'an, China
    • Xijing Hospital of the Fourth Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Breast cancer patients undergoing surgery at the Fudan University Shanghai Cancer Center, the First Hospital of China Medical University, Wuhan Union Hospital and Xijing Hospital of the Fourth Military Medical University.

Description

Inclusion Criteria:

• Diagnosed with breast cancer and underwent surgery
• Be going to receive one or more of chemotherapy, radiotherapy, targeted therapy, endocrine therapy, and immunotherapy
• With the ability to understand and communicate in Chinese
• Provided informed consent

Exclusion Criteria:

• Illness was considered too severe for participation
• With cognitive or psychiatric disorders

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Financial toxicity	Measured with the Comprehensive Scores for Financial Toxicity Based on The Patient-reported Outcome Measures (COST-PROM). The total score is 0-44, and the lower the score, the more severe financial toxicity.	Baseline, 3 months, 6 months, and 12 months
Physical symptom burden	Measured with the Breast Cancer Prevention Trial Eight Symptom Scale (BESS), which is a 5-point severity scale. The higher the score, the more severe the physical symptom burden.	Baseline, 3 months, 6 months, and 12 months
Psychological symptom burden	Measured with Psychologic Symptom Distress Score (PHYS) of Memorial Symptom Assessment Scale Short Form (MSAS-SF), which adopted Likert 4 scale. The higher the score, the more severe the psychological symptom burden.	Baseline, 3 months, 6 months, and 12 months

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2022
• Primary Completion (Estimated): March 31, 2024
• Study Completion (Estimated): March 31, 2024

Study Registration Dates

• First Submitted: July 20, 2023
• First Submitted That Met QC Criteria: July 20, 2023
• First Posted (Actual): July 28, 2023

Study Record Updates

• Last Update Posted (Actual): August 1, 2023
• Last Update Submitted That Met QC Criteria: July 27, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Financial Stress
• Other Study ID Numbers: YKuang

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No