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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:
Researchers will compare the financial navigation program with usual oncology care to preliminarily evaluate its effectiveness.
Participants will receive comprehensive information support, including:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
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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 | 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:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. | 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. |
| 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 since baseline |
| Financial toxicity |
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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 |
|---|---|---|---|
| 40124659 | Derived | 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. |
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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. |
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| 1 month after discharge in Financial Navigation Arm |
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 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 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 since baseline |