An interventional study of Financial Navigation and Usual Care in Breast Neoplasm Female, Financial Toxicity and Financial Navigation, sponsored by Fudan University. Completed at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-25.
Sponsored by Fudan University · Not applicable, Interventional, and Supportive care
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:
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 26 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
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
Behavioral: Financial Navigation
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.
Other: Usual Care
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
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 month after discharge in Financial Navigation Arm
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 1st month since baseline
Plan to share: No — We do not plan to share individual participant data due to privacy concerns and confidentiality agreements with participants.
No publications or documents are linked to this record.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Fudan University