Breast Neoplasm FemaleNCT06484140
Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China
A study testing Financial Navigation in people with Breast Neoplasm Female and Financial Toxicity, run by Fudan University at 1 site in China.
Trial summary
The goal of this study is to access the impact of a financial navigation program on improving financial toxicity among patients with breast cancer in China. The main questions it aims to answer are: Does the intervention alleviate participants' financial toxicity? Does the intervention enhance participants'… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasm Female, Financial Toxicity, Financial Navigation
- What is being tested?
- Financial Navigation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteChina
- Study dates
- 17 Jun 2024to 17 Nov 2024
- Phase
- Interventional
- 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
Who may be able to join
- Newly diagnosed with breast cancer and undergoing surgery during this admission;
- Female, age 18 years or older;
- Receiving or expected to receive one or more of the following therapies: chemotherapy, radiotherapy, endocrine therapy, targeted therapy, and immunotherapy;
- Eastern Cooperative Oncology Group Performance Status 0-2;
- Provided informed consent to participate in this study.
Who cannot join
- Diagnosed with ductal carcinoma in situ (DCIS)
- Presence of any serious psychiatric disorders;
- Cognitive impairments;
- Difficulty in reading, writing, or communicating in Chinese.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Evaluation of the Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China
The goal of this study is to access the impact of a financial navigation program on improving financial toxicity among patients with breast cancer in China.
The main questions it aims to answer are:
Read more
- Does the intervention alleviate participants' financial toxicity?
- Does the intervention enhance participants' cost-related health literacy?
- Does the intervention improve participants' shared decision-making?
- Does the intervention reduce participants' perceived stress?
Researchers will compare the financial navigation program with usual oncology care to evaluate its effectiveness.
Participants will receive the comprehensive financial navigation, including:
- Needs assessment;
- Cost-related health education, mainly including topics regarding communication of cost, treatment-related cost, health insurance policies, and family support;
- Resource and service referral;
- Personalized counseling.
- Being tested
- Financial Navigation, Usual Care
- Medical subject headings
- Financial Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Financial NavigationBehavioural
During hospitalization, participants will receive needs assessment, and one-on-one cost-related health education with a material booklet. Resource and service referral will be delivered face-to-face or by phone when the navigator identifies unaddressed problems. Within three months after discharge, participants will receive monthly follow-up phone calls and personalized counseling via WeChat.
Usual CareOther
Participants will receive usual oncology care during hospitalization and regular follow-up after discharge. Participants have the freedom to utilize any financial resources, but financial navigators do not offer comprehensive information support.
| Study group | Role | What they receive |
|---|---|---|
| Financial Navigation | Experimental | Participants will receive financial navigation service, including
* Needs Assessment: provide a brief introduction of cancer-related FT and assess patients' information needs using a self-made cost-related health literacy questionnaire;
* Cost-Related Health Education: mainly include topics regarding communication of cost, treatment-related cost, health insurance policies, and family support;
* Resource and Service Referral: promote timely referral to financial assistance programs and clinical professionals when identify unaddressed problems;
* Personalized Counseling Module: provide one-on-one counseling for symptom management, cost-related issues, and coping strategies. Receives: Behavioral: Financial Navigation |
| Usual Care | Active comparator | Participants will receive usual care during hospitalization and regular follow-up after discharge. Participants have the freedom to utilize any financial resources, but financial navigators do not offer comprehensive information support. When participants actively inquire about cancer treatment-related costs or financial planning strategies, financial navigators will answer their questions. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Financial toxicity
Financial toxicity will be measured with the Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy Version 2 (COST-FACIT-V2); lower scores (range, 0-44) indicating greater financial toxicity.
Measured: Baseline, 1st month and 3rd month since baseline
Material domain of financial toxicity
Material domain of financial toxicity will be measured with 2 items adapted from the Medical Expenditure Panel Survey (MEPS).
Measured: 1st month and 3rd month since baseline
Behavioral domain of financial toxicity
Behavioral domain of financial toxicity will be measured by employment changes and cost-related nonadherence with 6 items adapted from MEPS and previous literature.
Measured: 1st month and 3rd month since baseline
Secondary outcomes (3)
Cost-related health literacy
The cost-related health literacy will be measured with homemade 10-item questionnaire, with higher scores indicating higher cost-related health literacy.
Measured: Baseline, 1st month and 3rd month since baseline
Shared decision-making
The shared decision-making ability will be measured with 9-item shared decision-making questionnaire (SDM-Q-9); higher scores (range, 0-45) indicating a greater degree of participants' involvement in shared decision-making.
Measured: Baseline, 1st month and 3rd month since baseline
Perceived stress
The perceived stress will be measured with Perceived Stress Scale (PSS); higher scores (range, 0-56) indicating greater perceived stress.
Measured: Baseline, 1st month and 3rd month since baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2024
- Study start17 Jun 2024
- Primary completion11 Nov 2024
- Study completion17 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Neoplasm FemaleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoyi Yuan, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06484140
- Sponsor's protocol ID
- XYuan2312288-16
- Status last verified
- Jun 2024
- First submitted
- 26 Jun 2024
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share individual participant data due to privacy concerns and confidentiality agreements with participants.
Publications
Jing F, Yuan X, Tang Y, Liu Y, Huang Y, Chen L, Tang L, Qiu J, Xing W. The effects of a financial navigation intervention on financial toxicity among patients with breast cancer in China: A randomized controlled trial. Breast. 2026 Aug;88:104824. doi: 10.1016/j.breast.2026.104824. Epub 2026 May 27.
PubMed 42224905
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China
- ClinicalTrials.gov ID
- NCT06484140
- Acronym / sponsor ID
- XYuan2312288-16
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 17 Jun 2024 (actual)
- Primary completion
- 11 Nov 2024 (actual)
- Study completion
- 17 Nov 2024 (actual)
- First posted
- 3 Jul 2024 (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.
The goal of this study is to access the impact of a financial navigation program on improving financial toxicity among patients with breast cancer in China.
The main questions it aims to answer are:
- Does the intervention alleviate participants' financial toxicity?
- Does the intervention enhance participants' cost-related health literacy?
- Does the intervention improve participants' shared decision-making?
- Does the intervention reduce participants' perceived stress?
Researchers will compare the financial navigation program with usual oncology care to evaluate its effectiveness.
Participants will receive the comprehensive financial navigation, including:
- Needs assessment;
- Cost-related health education, mainly including topics regarding communication of cost, treatment-related cost, health insurance policies, and family support;
- Resource and service referral;
- Personalized counseling.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Financial Navigation | Experimental | Behavioral: Financial NavigationParticipants will receive financial navigation service, including * Needs Assessment: provide a brief introduction of cancer-related FT and assess patients' information needs using a self-made cost-related health literacy questionnaire; * Cost-Related Health Education: mainly include topics regarding communication of cost, treatment-related cost, health insurance policies, and family support; * Resource and Service Referral: promote timely referral to financial assistance programs and clinical professionals when identify unaddressed problems; * Personalized Counseling Module: provide one-on-one counseling for symptom management, cost-related issues, and coping strategies. |
| Usual Care | Active comparator | Other: Usual CareParticipants will receive usual care during hospitalization and regular follow-up after discharge. Participants have the freedom to utilize any financial resources, but financial navigators do not offer comprehensive information support. When participants actively inquire about cancer treatment-related costs or financial planning strategies, financial navigators will answer their questions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Newly diagnosed with breast cancer and undergoing surgery during this admission;
- Female, age 18 years or older;
- Receiving or expected to receive one or more of the following therapies: chemotherapy, radiotherapy, endocrine therapy, targeted therapy, and immunotherapy;
- Eastern Cooperative Oncology Group Performance Status 0-2;
- Provided informed consent to participate in this study.
Key exclusion criteria (4 listed)
- Diagnosed with ductal carcinoma in situ (DCIS)
- Presence of any serious psychiatric disorders;
- Cognitive impairments;
- Difficulty in reading, writing, or communicating in Chinese.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Financial NavigationDuring hospitalization, participants will receive needs assessment, and one-on-one cost-related health education with a material booklet. Resource and service referral will be delivered face-to-face or by phone when the navigator identifies unaddressed problems. Within three months after discharge, participants will receive monthly follow-up phone calls and personalized counseling via WeChat. | Behavioural | Financial Navigation |
| Usual CareParticipants will receive usual oncology care during hospitalization and regular follow-up after discharge. Participants have the freedom to utilize any financial resources, but financial navigators do not offer comprehensive information support. | Other | Usual Care |
Primary outcome
Financial toxicity
Time frame: Baseline, 1st month and 3rd month since baseline
Financial toxicity will be measured with the Comprehensive Score for Financial Toxicity-Functional Assessment of Chronic Illness Therapy Version 2 (COST-FACIT-V2); lower scores (range, 0-44) indicating greater financial toxicity.
Material domain of financial toxicity
Time frame: 1st month and 3rd month since baseline
Material domain of financial toxicity will be measured with 2 items adapted from the Medical Expenditure Panel Survey (MEPS).
Behavioral domain of financial toxicity
Time frame: 1st month and 3rd month since baseline
Behavioral domain of financial toxicity will be measured by employment changes and cost-related nonadherence with 6 items adapted from MEPS and previous literature.
3 secondary outcomes
Cost-related health literacy
Time frame: Baseline, 1st month and 3rd month since baseline
Shared decision-making
Time frame: Baseline, 1st month and 3rd month since baseline
Perceived stress
Time frame: Baseline, 1st month and 3rd month since baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Derived from this study: PubMed 42224905Jing F, Yuan X, Tang Y, Liu Y, Huang Y, Chen L, Tang L, Qiu J, Xing W. The effects of a financial navigation intervention on financial toxicity among patients with breast cancer in China: A randomized controlled trial. Breast. 2026 Aug;88:104824. doi: 10.1016/j.breast.2026.104824. Epub 2026 May 27.
- Individual participant dataSharing planned: No. We do not plan to share individual participant data due to privacy concerns and confidentiality agreements with participants.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Financial Navigation in people with Breast Neoplasm Female and Financial Toxicity, run by Fudan University at 1 site 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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, 1st month and 3rd month since baseline). 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?
On the ClinicalTrials.gov record for NCT06484140, which also lists 1 linked publication.
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 27 Feb 2025.