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Trial Title:
A Longitudinal Study of the Trajectory of Financial Toxicity and Its Relationship With Symptom Burden in Breast Cancer Patients
NCT ID:
NCT05964816
Condition:
Financial Toxicity
Conditions: Official terms:
Financial Stress
Study type:
Observational
Overall status:
Active, not recruiting
Study design:
Time perspective:
Prospective
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
Female
Gender based:
Yes
Gender description:
Participant eligibility is based on self-representation of gender identity.
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fudan University Shanghai Cancer Center
Address:
City:
Shanghai
Country:
China
Facility:
Name:
The First Hospital of China Medical University
Address:
City:
Shenyang
Country:
China
Facility:
Name:
Wuhan Union Hospital
Address:
City:
Wuhan
Country:
China
Facility:
Name:
Xijing Hospital of the Fourth Military Medical University
Address:
City:
Xi'an
Country:
China
Start date:
November 16, 2022
Completion date:
March 31, 2024
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05964816
