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Clinical Trials/NCT06484140
NCT06484140
Completed
Not Applicable

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

Fudan University1 site in 1 country82 target enrollmentJune 17, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Neoplasm Female
Sponsor
Fudan University
Enrollment
82
Locations
1
Primary Endpoint
Material domain of financial toxicity
Status
Completed
Last Updated
last year

Overview

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.
Registry
clinicaltrials.gov
Start Date
June 17, 2024
End Date
November 17, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Xiaoyi Yuan

Principal Investigator

Fudan University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Material domain of financial toxicity

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • Perceived stress(Baseline, 1st month and 3rd month since baseline)
  • Shared decision-making(Baseline, 1st month and 3rd month since baseline)
  • Cost-related health literacy(Baseline, 1st month and 3rd month since baseline)

Study Sites (1)

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