Breast Neoplasm Female, Financial Navigation, Financial Toxicity
Conditions
Brief summary
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: * Does the intervention alleviate participants' financial toxicity? * Does the intervention enhance participants' cost-related health literacy? * Does the intervention improve participants' shared decision-making? * Does the intervention reduce participants' perceived stress? Researchers will compare the financial navigation program with usual oncology care to evaluate its effectiveness. Participants will receive the comprehensive financial navigation, including: * Needs assessment; * Cost-related health education, mainly including topics regarding communication of cost, treatment-related cost, health insurance policies, and family support; * Resource and service referral; * Personalized counseling.
Interventions
BEHAVIORALFinancial Navigation
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.
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
* Newly diagnosed with breast cancer and undergoing surgery during this admission; * Female, age 18 years or older; * Receiving or expected to receive one or more of the following therapies: chemotherapy, radiotherapy, endocrine therapy, targeted therapy, and immunotherapy; * Eastern Cooperative Oncology Group Performance Status 0-2; * Provided informed consent to participate in this study.
Exclusion criteria
* Diagnosed with ductal carcinoma in situ (DCIS) * Presence of any serious psychiatric disorders; * Cognitive impairments; * Difficulty in reading, writing, or communicating in Chinese.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Financial toxicity | Baseline, 1st month and 3rd 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 and 3rd 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 and 3rd 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost-related health literacy | Baseline, 1st month and 3rd 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. |
| Shared decision-making | Baseline, 1st month and 3rd month since baseline | 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. |
| Perceived stress | Baseline, 1st month and 3rd month since baseline | The perceived stress will be measured with Perceived Stress Scale (PSS); higher scores (range, 0-56) indicating greater perceived stress. |
Countries
China
Outcome results
None listed