Breast Neoplasm FemaleNCT06355440
Pilot Study of 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 pilot study is to access the feasibility and impact of a financial navigation program on improving financial toxicity among patients with breast cancer in China. 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
- 26 participants
- Where
- 1 siteChina
- Study dates
- 18 Feb 2024to 7 May 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
- (1) Newly diagnosed with breast cancer and undergoing surgery during this admission;
- (2) Female, age 18 years or older;
- (3) Receiving or expected to receive one or more of the following therapies: chemotherapy, radiotherapy, endocrine therapy, targeted therapy, and immunotherapy;
- (4) Eastern Cooperative Oncology Group Performance Status 0-2;
- (5) Provided informed consent to participate in this study.
Who cannot join
- (1) Diagnosed with ductal carcinoma in situ (DCIS)
- (2) Presence of any serious psychiatric disorders;
- (3) Cognitive impairments;
- (4) 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
The goal of this pilot study is to access the feasibility and 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
- Is the intervention feasible and acceptable among participants?
- Does the intervention enhance participants' cost-related health literacy?
- Does the intervention reduce participants' financial toxicity?
Researchers will compare the financial navigation program with usual oncology care to preliminarily evaluate its effectiveness.
Participants will receive comprehensive information support, including:
- Strategies on patient-physician costs discussion
- Skills for inquiring and tracking treatment-related costs
- Basic knowledge about health insurance
- Guidance on accessing and applying for financial assistance
- Suggestions for returning to normal life and work
- Strategies for holding a financial-related family meeting
- 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
One-on-one information support with material booklets during hospitalization. Weekly financial navigation information will be sent via WeChat after discharge for 1 month.
The financial navigation encompasses comprehensive information support:
- Strategies on patient-physician costs discussion
- Skills for inquiring and tracking treatment-related costs
- Basic knowledge about health insurance
- Guidance on accessing and applying for financial assistance
- Suggestions for returning to normal life and work
- Strategies for holding a financial-related family meeting
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. During their hospitalization, participants will receive face-to-face information support with material booklets. Following discharge, weekly financial navigation information will be sent via WeChat for 1 month.
The financial navigation encompasses comprehensive information support:
* Strategies on patient-physician costs discussion
* Skills for inquiring and tracking treatment-related costs
* Basic knowledge about health insurance
* Guidance on accessing and applying for financial assistance
* Suggestions for returning to normal life and work
* Strategies for holding a financial-related family meeting 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.
Eligibility rate
The eligibility rate will be calculated as the proportion of participants who meet the eligibility criteria among the total number of participants who will be assessed for eligibility. Reasons for participants' ineligibility will be recorded.
Measured: Approximately 1 month
Consent rate
The consent rate will be calculated as the proportion of eligible participants who consent to participate among those who will be approached and eligible for participation. Reasons for participants' refusal to participate will be recorded.
Measured: Approximately 1 month
Attrition rate
The attrition rate will be calculated as the percentage of participants who withdraw from or drop out of the study after enrolment. Reasons for participants' withdrawal or dropout will be recorded.
Measured: Through study completion, an average of 3 month
Adherence rate
The adherence rate will be calculated as the proportion of participants completing the entire program. Reasons for participants' nonadherence to the intervention will be recorded.
Measured: Through study completion, an average of 3 month
Patient-reported satisfaction
Participants' satisfaction will be measured with homemade 5 item questionnaire, with higher scores indicating higher satisfaction.
Measured: 1 month after discharge in Financial Navigation Arm
Qualitative assessment of the intervention
Participants' experiences will be captured through one-on-one, semi-structured qualitative interviews.
Measured: 1 month after discharge in Financial Navigation Arm
Secondary outcomes (4)
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 since baseline
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 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 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 since baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start18 Feb 2024
- Primary completion28 Mar 2024
- Study completion7 May 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
- 26 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
- NCT06355440
- Sponsor's protocol ID
- 2312288-16
- Status last verified
- Jun 2024
- First submitted
- 28 Mar 2024
- Last updated
- 25 Sep 2024
- 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
Yuan X, Chen L, Sun Y, Kuang Y, Ruan J, Tang L, Qiu J, Xing W. The development and preliminary evaluation of a financial navigation program among patients with breast cancer in China. Asia Pac J Oncol Nurs. 2025 Feb 17;12:100668. doi: 10.1016/j.apjon.2025.100668. eCollection 2025 Dec.
PubMed 40124659
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China
- ClinicalTrials.gov ID
- NCT06355440
- Acronym / sponsor ID
- 2312288-16
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 18 Feb 2024 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 7 May 2024 (actual)
- First posted
- 9 Apr 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 pilot study is to access the feasibility and 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:
- Is the intervention feasible and acceptable among participants?
- Does the intervention enhance participants' cost-related health literacy?
- Does the intervention reduce participants' financial toxicity?
Researchers will compare the financial navigation program with usual oncology care to preliminarily evaluate its effectiveness.
Participants will receive comprehensive information support, including:
- Strategies on patient-physician costs discussion
- Skills for inquiring and tracking treatment-related costs
- Basic knowledge about health insurance
- Guidance on accessing and applying for financial assistance
- Suggestions for returning to normal life and work
- Strategies for holding a financial-related family meeting
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. During their hospitalization, participants will receive face-to-face information support with material booklets. Following discharge, weekly financial navigation information will be sent via WeChat for 1 month. The financial navigation encompasses comprehensive information support: * Strategies on patient-physician costs discussion * Skills for inquiring and tracking treatment-related costs * Basic knowledge about health insurance * Guidance on accessing and applying for financial assistance * Suggestions for returning to normal life and work * Strategies for holding a financial-related family meeting |
| 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)
- (1) Newly diagnosed with breast cancer and undergoing surgery during this admission;
- (2) Female, age 18 years or older;
- (3) Receiving or expected to receive one or more of the following therapies: chemotherapy, radiotherapy, endocrine therapy, targeted therapy, and immunotherapy;
- (4) Eastern Cooperative Oncology Group Performance Status 0-2;
- (5) Provided informed consent to participate in this study.
Key exclusion criteria (4 listed)
- (1) Diagnosed with ductal carcinoma in situ (DCIS)
- (2) Presence of any serious psychiatric disorders;
- (3) Cognitive impairments;
- (4) 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 NavigationOne-on-one information support with material booklets during hospitalization. Weekly financial navigation information will be sent via WeChat after discharge for 1 month. The financial navigation encompasses comprehensive information support: * Strategies on patient-physician costs discussion * Skills for inquiring and tracking treatment-related costs * Basic knowledge about health insurance * Guidance on accessing and applying for financial assistance * Suggestions for returning to normal life and work * Strategies for holding a financial-related family meeting | 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
Eligibility rate
Time frame: Approximately 1 month
The eligibility rate will be calculated as the proportion of participants who meet the eligibility criteria among the total number of participants who will be assessed for eligibility. Reasons for participants' ineligibility will be recorded.
Consent rate
Time frame: Approximately 1 month
The consent rate will be calculated as the proportion of eligible participants who consent to participate among those who will be approached and eligible for participation. Reasons for participants' refusal to participate will be recorded.
Attrition rate
Time frame: Through study completion, an average of 3 month
The attrition rate will be calculated as the percentage of participants who withdraw from or drop out of the study after enrolment. Reasons for participants' withdrawal or dropout will be recorded.
Adherence rate
Time frame: Through study completion, an average of 3 month
The adherence rate will be calculated as the proportion of participants completing the entire program. Reasons for participants' nonadherence to the intervention will be recorded.
Patient-reported satisfaction
Time frame: 1 month after discharge in Financial Navigation Arm
Participants' satisfaction will be measured with homemade 5 item questionnaire, with higher scores indicating higher satisfaction.
Qualitative assessment of the intervention
Time frame: 1 month after discharge in Financial Navigation Arm
Participants' experiences will be captured through one-on-one, semi-structured qualitative interviews.
4 secondary outcomes
Cost-related health literacy
Time frame: Baseline, 1st month since baseline
Financial toxicity
Time frame: Baseline, 1st month since baseline
Material domain of financial toxicity
Time frame: 1st month since baseline
Behavioral domain of financial toxicity
Time frame: 1st 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 25 Sep 2024.
- Derived from this study: PubMed 40124659Yuan X, Chen L, Sun Y, Kuang Y, Ruan J, Tang L, Qiu J, Xing W. The development and preliminary evaluation of a financial navigation program among patients with breast cancer in China. Asia Pac J Oncol Nurs. 2025 Feb 17;12:100668. doi: 10.1016/j.apjon.2025.100668. eCollection 2025 Dec.
- 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 25 Sep 2024. 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?
Eligibility rate (time frame: Approximately 1 month). The study lists 6 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 NCT06355440, 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 25 Sep 2024.