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

Evaluation of the Financial Navigation Program for Improving Financial Toxicity Among Breast Cancer in China

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.

Study Overview

• Status: Completed
• Conditions: Breast Neoplasm Female; Financial Toxicity; Financial Navigation
• Intervention / Treatment: Other: Usual Care; Behavioral: Financial Navigation

• Study Type: Interventional
• Enrollment (Actual): 82
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Fudan University Shanghai Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Other: Usual 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.
Experimental: 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.	Behavioral: Financial 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 1st month and 3rd 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).	1st month and 3rd 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.	1st month and 3rd month since baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 1st month and 3rd month since baseline
Shared decision-making	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.	Baseline, 1st month and 3rd month since baseline
Perceived stress	The perceived stress will be measured with Perceived Stress Scale (PSS); higher scores (range, 0-56) indicating greater perceived stress.	Baseline, 1st month and 3rd month since baseline

Collaborators and Investigators

• Sponsor: Fudan University

Study record dates

Study Major Dates

• Study Start (Actual): June 17, 2024
• Primary Completion (Actual): November 11, 2024
• Study Completion (Actual): November 17, 2024

Study Registration Dates

• First Submitted: June 26, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Behavioral Symptoms; Skin Diseases; Breast Diseases; Stress, Psychological; Financial Stress; Breast Neoplasms
• Other Study ID Numbers: XYuan2312288-16

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We do not plan to share individual participant data due to privacy concerns and confidentiality agreements with participants.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No