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

NCT ID: NCT06484140

Last Updated: 2025-02-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-17

Study Completion Date

2024-11-17

Brief Summary

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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

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Conditions

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Breast Neoplasm Female Financial Toxicity Financial Navigation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Financial Navigation

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fudan University

OTHER

Sponsor Role lead

Responsible Party

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Xiaoyi Yuan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Other Identifiers

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XYuan2312288-16

Identifier Type: -

Identifier Source: org_study_id

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