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

NCT06484140 | Completed

• 1 other identifier: XYuan2312288-16
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasm Female; Financial Toxicity; Financial Navigation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Cost-related health literacy

  Baseline, 1st month and 3rd month since baseline

• Shared decision-making

  Baseline, 1st month and 3rd month since baseline

• Perceived stress

  Baseline, 1st month and 3rd month since baseline

Study Arms (2)

Financial Navigation

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

Financial Navigation BEHAVIORAL

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.

Financial Navigation

Usual Care OTHER

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.

Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Diagnosed with ductal carcinoma in situ (DCIS)
• Presence of any serious psychiatric disorders;
• Cognitive impairments;
• Difficulty in reading, writing, or communicating in Chinese.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Financial Stress

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: July 3, 2024
• Study Start: June 17, 2024
• Primary Completion: November 11, 2024
• Study Completion: November 17, 2024
• Last Updated: February 27, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)