Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China
- Conditions
- Financial ToxicityBreast Neoplasm FemaleFinancial Navigation
- Interventions
- Behavioral: Financial NavigationOther: Usual Care
- Registration Number
- NCT06484140
- Lead Sponsor
- Fudan University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 82
- 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.
- Diagnosed with ductal carcinoma in situ (DCIS)
- Presence of any serious psychiatric disorders;
- Cognitive impairments;
- Difficulty in reading, writing, or communicating in Chinese.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Financial Navigation Financial Navigation Participants will receive financial navigation service, including * Needs Assessment: provide a brief introduction of cancer-related FT and assess patients' information needs using a self-made cost-related health literacy questionnaire; * Cost-Related Health Education: mainly include topics regarding communication of cost, treatment-related cost, health insurance policies, and family support; * Resource and Service Referral: promote timely referral to financial assistance programs and clinical professionals when identify unaddressed problems; * Personalized Counseling Module: provide one-on-one counseling for symptom management, cost-related issues, and coping strategies. Usual Care Usual Care 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.
- Primary Outcome Measures
Name Time Method 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).
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.
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 Outcome Measures
Name Time Method 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.
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.
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.
Trial Locations
- Locations (1)
Fudan University Shanghai Cancer Center
🇨🇳Shanghai, Shanghai, China