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

NCT05964816 | Unknown

• 1 other identifier: YKuang
• Study Type: observational
• Target: 485
• Locations: 1 country
• Sites: 4

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.

Conditions

Financial Toxicity

Outcome Measures

Primary Outcomes (3)

• 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

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Participant eligibility is based on self-representation of gender identity.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (4)

Fudan University Shanghai Cancer Center

Shanghai, China

Location

The First Hospital of China Medical University

Shenyang, China

Location

Wuhan Union Hospital

Wuhan, China

Location

Xijing Hospital of the Fourth Military Medical University

Xi'an, China

Location

MeSH Terms

Conditions

Financial Stress

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: July 28, 2023
• Study Start: November 16, 2022
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: August 1, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (4)