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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:
Researchers will compare the financial navigation program with usual oncology care to evaluate its effectiveness.
Participants will receive the comprehensive financial navigation, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Financial Navigation | Experimental | Participants will receive financial navigation service, including
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Financial Navigation | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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). | 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. | 1st month and 3rd month since baseline |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 1st month and 3rd month since baseline |
| Shared decision-making |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fudan University Shanghai Cancer Center | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42224905 | Derived | 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 May 27;88:104824. doi: 10.1016/j.breast.2026.104824. Online ahead of print. |
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We do not plan to share individual participant data due to privacy concerns and confidentiality agreements with participants.
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| ID | Term |
|---|---|
| D000086522 | Financial Stress |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| Usual Care | Other | 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. |
|
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. |
| 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. | Baseline, 1st month and 3rd month since baseline |