Financial ToxicityNCT05964816
A Longitudinal Study of the Trajectory of Financial Toxicity and Its Relationship With Symptom Burden in Breast Cancer Patients
An observational study of Financial Toxicity, run by Fudan University at 4 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Financial Toxicity
- How many people
- 485 participants
- Where
- 4 sitesChina
- Study dates
- 16 Nov 2022to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Illness was considered too severe for participation
- With cognitive or psychiatric disorders
Trial locations and contacts
4 sites in 1 country.
China4 sites
Fudan University Shanghai Cancer Center
Shanghai
The First Hospital of China Medical University
Shenyang
Wuhan Union Hospital
Wuhan
Xijing Hospital of the Fourth Military Medical University
Xi'an
About this study
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
- Medical subject headings
- Financial Stress
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Baseline, 3 months, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start16 Nov 2022
- Primary completion31 Mar 2024 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Financial ToxicityStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 485 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yi Kuang, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05964816
- Sponsor's protocol ID
- YKuang
- Status last verified
- Jul 2023
- First submitted
- 20 Jul 2023
- Last updated
- 1 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Longitudinal Study of the Trajectory of Financial Toxicity and Its Relationship With Symptom Burden in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT05964816
- Acronym / sponsor ID
- YKuang
- Conditions
- Financial Toxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 485 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 31 Mar 2024 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 28 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- Illness was considered too severe for participation
- With cognitive or psychiatric disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
Related trials for Financial Toxicity
Not yet recruiting
Financial Tools Access and Navigation (FinTAN)
Serious Mental Illness, Financial Hardship
Active, not recruiting
Economic Empowerment and Health Promotion of Uganda Grandmother-caregivers.
Financial Burden, Health Behavior
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
Recruiting
Medical Payment Case Management for Financial Toxicity in Patients With Primary Bone Tumors: A Randomized Controlled Trial
Bone Tumor, Bone Cancer
Active, not recruitingObservational study
Financial Toxicity in Cancer Patients
Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Financial Toxicity, run by Fudan University at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Financial toxicity (time frame: Baseline, 3 months, 6 months, and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.