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Clinical Trials/NCT05964816
NCT05964816
Active, not recruiting
Not Applicable

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

Fudan University4 sites in 1 country485 target enrollmentNovember 16, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Financial Toxicity
Sponsor
Fudan University
Enrollment
485
Locations
4
Primary Endpoint
Physical symptom burden
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
November 16, 2022
End Date
March 31, 2024
Last Updated
2 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yi Kuang

Principal Investigator

Fudan University

Eligibility Criteria

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

Outcomes

Primary Outcomes

Physical symptom burden

Time Frame: Baseline, 3 months, 6 months, and 12 months

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.

Financial toxicity

Time Frame: Baseline, 3 months, 6 months, and 12 months

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.

Psychological symptom burden

Time Frame: Baseline, 3 months, 6 months, and 12 months

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.

Study Sites (4)

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