Breast Neoplasm Female, Financial Navigation, Financial Toxicity
Conditions
Brief 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. 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
Interventions
BEHAVIORALFinancial Navigation
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
OTHERUsual Care
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.
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* (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.
Exclusion criteria
* (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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Qualitative assessment of the intervention | 1 month after discharge in Financial Navigation Arm | Participants' experiences will be captured through one-on-one, semi-structured qualitative interviews. |
| Consent rate | 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 | 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 | 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 | 1 month after discharge in Financial Navigation Arm | Participants' satisfaction will be measured with homemade 5 item questionnaire, with higher scores indicating higher satisfaction. |
| Eligibility rate | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Financial toxicity | Baseline, 1st 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 | 1st 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 | 1st 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. |
| Cost-related health literacy | Baseline, 1st month since baseline | The cost-related health literacy will be measured with homemade 10-item questionnaire, with higher scores indicating higher cost-related health literacy. |
Countries
China
Outcome results
None listed