Clinical trial NCT05964816: A Longitudinal Study of the Trajectory of Financial Toxicity and Its Relationship With Symptom Burden in Breast Cancer Patients
Official title: A Longitudinal Study of the Trajectory of Financial Toxicity and Its Relationship With Symptom Burden in Breast Cancer Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Financial Toxicity
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2023-07-28
Enrollment: 485
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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

Primary outcomes:
measure: Financial toxicity
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Physical symptom burden
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Psychological symptom burden
timeFrame: Baseline, 3 months, 6 months, and 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
city: Shenyang
country: China
facility: The First Hospital of China Medical University
city: Wuhan
country: China
facility: Wuhan Union Hospital
city: Xi'an
country: China
facility: Xijing Hospital of the Fourth Military Medical University
Study officials:
References: