Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China

Not Applicable

Completed

• Conditions: Financial Toxicity; Breast Neoplasm Female; Financial Navigation

• 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

Study Timeline

• Status Verified: 2024-06
• Study Start: 2024-06-17
• Study First Submitted: 2024-06-26
• Study First Submitted QC: 2024-06-26
• Study First Posted: 2024-07-03
• Primary Completion: 2024-11-11
• Study Completion: 2024-11-17
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 82

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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